Anda di halaman 1dari 41

Pieter H.

Joubert
Silvia M. Rogers

Strategic Scientific
and Medical Writing

The Road to Success

123
Strategic Scientific and Medical Writing
Pieter H. Joubert Silvia M. Rogers

Strategic Scientific and


Medical Writing
The Road to Success
Pieter H. Joubert Silvia M. Rogers
PHJ Consult Ltd. Mediwrite GmbH
Pangbourne Basel
United Kingdom Switzerland

ISBN 978-3-662-48315-2 ISBN 978-3-662-48316-9 (eBook)


DOI 10.1007/978-3-662-48316-9

Library of Congress Control Number: 2015956036

Springer Heidelberg New York Dordrecht London


Springer-Verlag Berlin Heidelberg 2015
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does not imply, even in the absence of a specific statement, that such names are exempt from the relevant
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The publisher, the authors and the editors are safe to assume that the advice and information in this book
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Preface

Need to write a short, succinct paper, a report which will capture the attention of the
reader and influence the outcome? Help is at hand in this punchy manual written by
two knowledgeable scientists and teachers with experience in the worlds of aca-
demia, industry, and regulation.
This book is written in easily accessible sections, each dealing with the practical
problems that a newcomer to the field may experience and seasoned writers need to
be reminded of. It is written with a lightness of touch, combining common sense
with illustrative examples of how to address different types of situations.
An attractive feature is that you, the reader, can test yourself on your planning
skills and performance and detect the errors you may not even have been aware of,
thereby improving your success rate in making important submissions.
But as the authors say, while learning these skills requires care and attention, it does
not need to be all drudgery and can also be enjoyable once the basic principles have been
mastered. Having read the book, you may say but I knew all these things before.
Good! So now is the opportunity to put them into practice, and by reading and noting the
plans outlined in this book, you will become an even better communicator.

Prof. Sir Alasdair Breckenridge (former Head of the MRCA, England)


May 2015

v
Contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Why Bother with Writing Skills? . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.2 The Key Components of Good Medical/Scientific Writing. . . . . . . . 2
1.2.1 Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.2 Science . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.3 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.4 Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.2.5 Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3 How to Plan a Document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.1 The Nature of the Document . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.2 The Desired Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.3 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.3.4 Target Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.5 Key Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.3.6 Sources of Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.4 Using a Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.5 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
2 Written Communication in Drug Development . . . . . . . . . . . . . . . . . . . 9
2.1 Where Is Written Communication Used in Drug Development? . . . 9
2.1.1 Recording Nonclinical Findings . . . . . . . . . . . . . . . . . . . . . . 10
2.1.2 Preparing Drug Development Documents . . . . . . . . . . . . . . . 10
2.1.3 Communicating with Regulatory Authorities and Other
Important Institutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
3 Written Communication in Academic Settings . . . . . . . . . . . . . . . . . . . 13
3.1 Where Is Communication Used in the Academic Setting? . . . . . . . . 13
3.2 Scientific Papers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
3.3 Theses and Dissertations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.3.1 Masters Thesis/Dissertation . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.3.2 Doctoral Dissertation/Thesis . . . . . . . . . . . . . . . . . . . . . . . . . 15

vii
viii Contents

3.4 Other Student Papers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17


3.4.1 Laboratory Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.4.2 Research Proposals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.5 Application for Ethics Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3.6 Grant Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.7 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
4 Language Pitfalls: Native English Speakers . . . . . . . . . . . . . . . . . . . . . . 25
4.1 Do Native English Speakers Have an Advantage? . . . . . . . . . . . . . . 25
4.2 Misused Terms and Expressions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.3 Problems with Singular and Plural Nouns . . . . . . . . . . . . . . . . . . . . . 27
4.3.1 Plurals of Non-English Nouns . . . . . . . . . . . . . . . . . . . . . . . . 27
4.3.2 Collective Nouns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.4 Punctuation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
4.4.1 Comma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.4.2 Hyphen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
4.4.3 Other Troublesome Punctuation Marks . . . . . . . . . . . . . . . . . 31
4.5 Jargonized Writing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.5.1 Carelessness and Sloppiness . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.5.2 Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.5.3 Nonparallel Clauses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
4.6 Sentence Structure and Word Order (Syntax) . . . . . . . . . . . . . . . . . . . 36
4.6.1 Dangling Modifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.6.2 Misplaced Modifiers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.7 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
5 Language Pitfalls: Nonnative English Speakers . . . . . . . . . . . . . . . . . . 39
5.1 Do Nonnative English Speakers Have a Disadvantage? . . . . . . . . . . 39
5.2 Main Troublemakers for Nonnative English Speakers . . . . . . . . . . . 39
5.2.1 Choice of Correct Tense. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
5.2.2 Avoiding Wordiness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
5.2.3 Active Versus Passive Writing . . . . . . . . . . . . . . . . . . . . . . . . 44
5.2.4 Nonessential and Essential Clauses . . . . . . . . . . . . . . . . . . . . 45
5.2.5 Use of Respectively . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
5.3 Lost in Translation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
6 Scientific Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
6.1 Why Does Everyone Suddenly Talk about Fraud and Plagiarism? . . 49
6.2 Causes of Scientific Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
6.3 Forms of Scientific Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.3.1 Data Fabrication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
6.3.2 Data Falsification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.3.3 Plagiarism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
6.4 Other Forms of Scientific Misconduct . . . . . . . . . . . . . . . . . . . . . . . . 53
6.4.1 Provision of Incorrect or Incomplete Information . . . . . . . . . 53
6.4.2 Omission of Publication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
6.4.3 List of Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Contents ix

6.5 Post-publication Misconduct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55


6.5.1 Storage and Retrieval of Data . . . . . . . . . . . . . . . . . . . . . . . . 55
6.5.2 Correction and Retraction of Publications and Expression
of Concern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
6.6 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
7 Key Statistical Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
7.1 Descriptive Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
7.2 Inferential Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
7.2.1 Parametric Tests for Two Datasets . . . . . . . . . . . . . . . . . . . . . 64
7.2.2 Nonparametric Tests for Small Datasets . . . . . . . . . . . . . . . . 66
7.2.3 Comparing Categories: Chi-Squared Test . . . . . . . . . . . . . . . 68
7.2.4 Tests for Multiple Samples . . . . . . . . . . . . . . . . . . . . . . . . . . 70
7.3 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
8 Tables and Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
8.1 Producing Sensible Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
8.2 Sensible Use of Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
8.2.1 Illustrating the Characteristics of a Database. . . . . . . . . . . . . 73
8.2.2 Comparing Databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
8.2.3 Showing Relationships Between Parameters . . . . . . . . . . . . . 75
8.2.4 Showing Trends over Time Using Arithmetic
Line Graphs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
8.2.5 Column Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
8.2.6 Inappropriate and Misleading Use of Graphs . . . . . . . . . . . . 80
8.3 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
9 International Conference on Harmonization (ICH)
and Other Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
9.1 Achievements by the International Conference
on Harmonization (ICH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85
9.2 Quality Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86
9.3 Safety Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
9.4 Efficacy Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
9.5 Multidisciplinary Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
9.6 Consistency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88
9.7 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
10 The Investigators Brochure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
10.1 Key Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
10.2 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
10.3 Emphasis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
10.4 Key Messages and Outcome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
10.5 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
x Contents

11 Initiating Clinical Programs (IND and IMPD) . . . . . . . . . . . . . . . . . . 97


11.1 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97
11.2 CTA Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
11.3 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
12 The Common Technical Document: Overviews and Summary
Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
12.1 The Key Components of the CTD . . . . . . . . . . . . . . . . . . . . . . . . . 103
12.1.1 The First Component (Module 1) . . . . . . . . . . . . . . . . . . 104
12.1.2 The Second Component (Module 2) . . . . . . . . . . . . . . . . 104
12.1.3 The Third Component (Modules 3, 4, and 5) . . . . . . . . . 105
12.2 Summaries That Are More Than Summaries . . . . . . . . . . . . . . . . 105
12.3 The Summaries (Module 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
12.3.1 Clinical and Nonclinical Overviews
(Modules 2.4 and 2.5) . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
12.4 Where Do I Start? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
12.5 Selecting the Expert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
12.6 Common Mistakes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
12.7 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
13 Study Protocols and Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
13.1 Study Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
13.1.1 Where Do I Start? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
13.1.2 Key Elements of a Protocol . . . . . . . . . . . . . . . . . . . . . . . 115
13.1.3 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
13.2 Study Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
13.2.1 Structure and Content . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
13.2.2 Abbreviated Study Reports . . . . . . . . . . . . . . . . . . . . . . . . 122
13.3 Planning, Teamwork, and Prototyping. . . . . . . . . . . . . . . . . . . . . . . 123
13.4 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
14 Scientific Papers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
14.1 Publication Ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
14.2 Why Publish? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
14.3 Selecting the Journal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
14.4 How Do I Plan and Write a Scientific Paper? . . . . . . . . . . . . . . . . 127
14.5 Where Do I Start? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
14.5.1 Title and Authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
14.5.2 Keywords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
14.5.3 Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
14.5.4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
14.5.5 Materials and Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . 129
14.5.6 Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
14.5.7 Discussion and Conclusions . . . . . . . . . . . . . . . . . . . . . . 130
14.5.8 Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
14.5.9 Disclosures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
14.5.10 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
14.6 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Contents xi

15 Publication Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133


15.1 Publication Strategy in a Commercial Drug
Development Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
15.1.1 Data That Benefit the Program
and Must Be Published . . . . . . . . . . . . . . . . . . . . . . . . . . 134
15.1.2 Publications of No Specific Benefit to the Program . . . . 135
15.2 Publication in an Academic Setting . . . . . . . . . . . . . . . . . . . . . . . . 135
15.3 Final Thoughts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Glossary of Abbreviations Used in This Book . . . . . . . . . . . . . . . . . . . . . 137

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Books . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Published Literature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
List of Tables

Table 1.1 Template for the planning of documents


Table 3.1 Suggested structure of a masters thesis
Table 3.2 Suggested structure of a laboratory report
Table 3.3 Suggested structure of a research proposal
Table 3.4 Questions asked by reviewers of grant applications
Table 4.1 Words and expressions frequently causing problems
Table 4.2 Verbs that are commonly confused
Table 4.3 Latin and Greek singular and plural suffixes
Table 4.4 Comma rules
Table 4.5 Hyphen rules
Table 5.1 The most common ESL mistakes in science writing
Table 5.2 The tense rules
Table 5.3 Strategies for eliminating wordiness
Table 7.1 Example of a small dataset (n = 10)
Table 7.2 Determining variance and standard deviation (square root of the mean
variance)
Table 7.3 Abbreviated table of Students t-distribution
Table 7.4 Body mass of football players and Olympic marathon runners (raw
data, means, and standard deviations)
Table 7.5 Diastolic blood pressure in patients with essential hypertension before
and after 4 weeks of treatment with a beta-blocker
Table 7.6 Illustration of how u is determined in two samples of four data points
each
Table 7.7 Ages of gymnasts and 1500 m runners
Table 7.8 Pain scores on a 10-point scale after treatment with a placebo or an
analgesic
Table 7.9 Some representative probabilities for T for the Wilcoxon signed-rank
test
Table 7.10 2 2 Contingency table for two treatments with two categories of
response (2 2 table)
Table 7.11 Chi-squared distribution table

xiii
xiv List of Tables

Table 8.1 Age, mass, height, and body mass index in four groups of professional
athletes
Table 8.2 Trough plasma concentrations in healthy volunteers after a single dose
(750 mg) of four different formulations of a new drug intended for a
phase III clinical study
Table 9.1 ICH quality guidelines
Table 9.2 ICH safety guidelines
Table 9.3 ICH efficacy guidelines
Table 9.4 Multidisciplinary guidelines
Table 9.5 ICH multidisciplinary guidelines
Table 9.6 Key regulatory guidelines
Table 10.1 ICH guidelines on the Investigators Brochure
Table 10.2 Contents of the Investigators Brochure
Table 10.3 Template for planning an IB in conjunction with a specific study proto-
col, aimed at the investigator and staff
Table 11.1 FDA guidelines for IND submissions
Table 11.2 Key elements of the IND application
Table 11.3 European Commission guidance on CTA submissions
Table 11.4 Key elements of the CTA application
Table 11.5 Suggested preparation template for CTA (IMPD) or IND
Table 12.1 Regulatory guidance on Module 1 of the CTD
Table 12.2 Components of Module 2 of the CTD
Table 12.3 ICH guidance on preparing an electronic CTD
Table 12.4 Proposed planning template for the CTD
Table 12.5 Regulatory guidance on nonclinical overview preparation
Table 12.6 Structure of nonclinical overview
Table 12.7 Regulatory guidance on clinical overview preparation
Table 12.8 Structure of clinical overview
Table 12.9 Common mistakes when compiling a CTD
Table 13.1 Regulatory and other guidance on protocol preparation
Table 13.2 Template for planning a study protocol
Table 13.3 Regulatory guidance on studies in children
Table 13.4 Example of a simple schedule of assessments
Table 13.5 Guidance on ethics and informed consent
Table 13.6 Contents of a clinical study report according to the ICH3 guideline
Table 13.7 Suggested numbering of study report contents
Table 13.8 Regulatory guidance on abbreviated studies
Table 14.1 Impact factor for the top 10 medical journals in 2015
List of Figures

Fig. 1.1 Key aspects for the planning of a scientific/medical document


Fig. 7.1 Schematic representation of a normal distribution curve
Fig. 7.2 Schematic presentation of a skewed distribution (a skewed to the right,
b skewed to the left)
Fig. 7.3 Schematic presentation of a bimodal distribution (two subpopulations)
Fig. 7.4 Diastolic blood pressure in 10 patients before and after treatment with
a beta-blocker for 4 weeks
Fig. 8.1 Plasma concentrations (mg/L) shown as A, scatter plot; B, scatter plot
with overlapping values spread horizontally; C, means SD; D, box-
and-whisker plot (box, median between second and third quartiles;
whiskers, first quartile below the box and fourth quartile above the box)
Fig. 8.2 Trough plasma concentrations (mg/L) of four different potential formu-
lations of a new drug for a phase III study
Fig. 8.3 Plasma concentrations (expressed as AUC) after a single dose of a new
drug given to 32 subjects with varying degrees of renal impairment. A
linear regression (straight-line fit) was obtained using y = mx + c. Note:
x = plasma concentration, m = slope, y = creatinine clearance,
c = intercept on the y-axis
Fig. 8.4 A typical concentration-effect curve shown as an Emax model. E effect,
Emax maximum effect, EC50 concentration that produces 50% of the
effect
Fig. 8.5 Dose-response relationship shown as a linear regression model (same
data as in Fig. 8.4)
Fig. 8.6 Typical concentration versus time curve. Note that the T1/2 is obtained
from the time it took for the concentration to decrease by 50% (100 to
50 mg/L)
Fig. 8.7 Data of Fig. 8.6 plotted with the plasma concentrations as log values
Fig. 8.8 Change in numbers of two animal populations over time in a nature
reserve, shown as actual numbers on the left and their logarithms on the
right

xv
xvi List of Figures

Fig. 8.9 Kaplan-Meier plot showing survival in patients with a specific type of
cancer receiving either standard treatment (ST) with an investigational
drug or placebo added to their treatment
Fig. 8.10 Average number of cases of carbon monoxide poisoning seen per
month (average of 5 years) in an African village with no electricity
Fig. 8.11 Data shown in Fig. 8.10, broken down into age groups
Fig. 8.12 Responder rates for drug A and drug B. An inappropriate Y-axis scale
is misleading and makes a small difference appear large
Fig. 8.13 Plasma concentrations in dogs receiving identical doses directly into
the stomach, small bowel, or large bowel (a log Y-axis makes the differ-
ences between the absorption sites appear smaller than they really are)
Fig. 8.14 Cmax versus dose, shown as the mean Cmax versus dose (left graph) and
individual values of Cmax versus dose (right graph). Using the mean
data makes the linear relationship appear clear and statistically signifi-
cant. Using all the individual data points shows that there is no statisti-
cal significance
Fig. 9.1 Organization and numbering of the ICH topics and guidelines
Fig. 10.1 Development of the Investigators Brochure and changes over time
Fig. 10.2 The IB viewed primarily as a GCP document
Fig. 11.1 Summary of the planning information required in IND and CTA
documentation
Fig. 12.1 Components of the common technical document (CTD)
Fig. 12.2 Summary of the overall approach for planning and producing the clini-
cal overview
About the Authors

Pieter H. Joubert, MBBCh, FCP(SA), MD

Pieter Joubert is a clinician specialized in internal


medicine in South Africa who trained in clinical
pharmacology at the University of Rochester,
USA. During a successful academic clinical pharma-
cology career, he was a member of several boards
and committees. He also reviewed applications for
approval of new drugs for the South African health
authority. His key areas of clinical experience are in
cardiovascular disease, nephrology, and diabetes. He
has extensive drug development experience in the
pharmaceutical industry, the major part as Global
Head of Clinical Pharmacology at F. Hofmann-La
Roche, Switzerland. He currently holds an honorary
professorship of pharmacology and therapeutics at the Medical University of
Southern Africa and a visiting professorship in pharmaceutical medicine at the
University of Surrey, UK. He has acted as a consultant to numerous pharmaceutical
and biotechnology companies and has published extensively in books and scientific
journals.

xvii
xviii About the Authors

Silvia M. Rogers, BSc hons., PhD

Silvia M. Rogers is the founder and owner of


MEDIWRITE GmbH, a successful small company
located in Basel, Switzerland. She trained at the
University of Liverpool, UK, in the Department of
Pharmacology and Therapeutics headed by Prof. Sir
Alasdair Breckenridge (former Head of the MRCA).
Before forming MEDIWRITE in 1994, she gained
extensive experience in key areas of pharmaceutical
research and development including project manage-
ment in a major pharmaceutical company. She lec-
tures on scientific writing at Basel University and has
provided extensive training in various aspects of
medical and scientific writing and presentation. She
has written many regulatory documents, study
reports, and scientific publications for clients and has
authored the popular book Mastering Scientific and
Medical Writing (2nd ed., Springer, 2014).
Chapter 1
Introduction

The quality of mercy is not straind,


It droppeth as the gentle rain from heaven
Upon the place beneath: it is twice blest;
It blesseth him that gives and him that takes:
Tis mightiest in the mightiest: it becomes
The throned monarch better than his crown;
His sceptre shows the force of temporal power,
The attribute to awe and majesty,
Wherein doth sit the dread and fear of kings;
But mercy is above this sceptred sway;
It is enthroned in the hearts of kings,
It is an attribute to God himself.
The Merchant of Venice, Shakespeare, 1596

1.1 Why Bother with Writing Skills?

There is wide consensus that the writings of William Shakespeare are of a high
literary standard that has survived the test of time. It is clear that if text of the scene
from the Merchant of Venice would be used as a bedtime story for a 3-year old, with
the intention of imprinting on a young mind the concept that compassion and
sympathy are useful attributes, it simply would not work. On the other hand, a story
in simple contemporary English of the mouse that took out a thorn from the
elephants foot would work as a bedtime story with a message on compassion.
In the area of medical and scientific writing, the underlying science in a document
may be solid and the use of language perfect, but if the text does not convey the
intended message to the target audience, the document might be a dismal failure. A
good document should not only be based on solid medical/scientific data but should
additionally convey the correct messages to the target audience to achieve the
desired outcome.

Springer-Verlag Berlin Heidelberg 2015 1


P.H. Joubert, S.M. Rogers, Strategic Scientific and Medical Writing:
The Road to Success, DOI 10.1007/978-3-662-48316-9_1
2 1 Introduction

As the authors of this book we aim to assist you in becoming successful medical
and scientific communicators, on top of being good writers. The key factor in
achieving this is to imagine yourself as being in the shoes of the target reader(s) of
your document and to pre-empt their response.
In most cases, we will discuss medical/scientific writing in the context of
pharmaceutical medicine and drug development. The principles, however, also
apply to academic fields and other areas of medical/scientific writing, as well as to
non-written means of communication.

1.2 The Key Components of Good Medical/Scientific Writing

The art of successful medical/scientific writing is all about transferring information


to a person or a group of people to achieve a specific outcome. Examples include:
Presenting nonclinical data to drug-regulatory professionals at the Food and
Drug Administration (FDA) to convince them that the available data on safety
and efficacy warrant approval of a single ascending-dose protocol in humans
Preparing an abbreviated study report of the data from the first study in humans
that recommends to your companys managerial board the discontinuation of
development of a compound expected to be a blockbuster
Preparing a manuscript on important new scientific data for publication in a
reputable journal, with the result that it will be accepted for publication and
widely read by the target audience
To be able to produce high-quality documents with a high probability of a
successful outcome, you should be aware of the requirements. Figure 1.1 summarizes
the key aspects you should consider in planning a document.

Science

Tools

Guidelines Language

Fig. 1.1 Key aspects for Strategy


the planning of a scientific/
medical document
Target audience, key messages, desired outcome
1.2 The Key Components of Good Medical/Scientific Writing 3

1.2.1 Strategy

The key to writing successful documents is to use the correct strategic approach. To
plan and execute a successful strategy, you have to familiarize yourself with the type
of document you wish to produce. You need to identify and understand your target
audience so that you can convey the key messages clearly, convincingly, and
concisely and achieve the desired outcome.
Documents always have to be reader-friendly. If you antagonize, bore, confuse,
or irritate the reader, your chances of a successful outcome are greatly diminished.
Documents should be well organized with appropriate headings and skillful use of
graphics. There should be a natural and logical flow, and the reader should not have
to hunt for information. If your document is easy to read and captures the attention
of the reader, you have a high probability of a positive outcome.

1.2.2 Science

In the area of drug development and pharmaceutical medicine, it is essential to use


solid, well-presented scientific data to support your key messages. This includes a
thorough review of the data from the literature as well as of the available nonclinical
and clinical data obtained in the drug development program. Apart from providing
available data, you should make clear what data are missing and what steps are
planned to obtain them. Any issues should be apparent upfront. Hiding or
downplaying issues is a recipe for disaster.

1.2.3 Guidelines

There are guidelines for most documents. Examples are internal company guidelines,
guidelines of regulatory authorities, or journal guidelines for authors. In general, it
is advisable to follow guidelines closely, as they represent the expectations of your
target reader(s). Guidelines are, however, exactly what the word suggests, namely,
the mere guidance for the preparation of a document. They cover the general
requirements but are usually not cast in stone. Sometimes, the guidelines do not fit
the issue you are concerned with, and you may have to make some adjustments.
However, any deviation from the guidelines should be made clear upfront, and your
decision should be justified and well motivated. Any deviation from a guideline
should add value, make the key message clearer, and enhance your chances of a
successful outcome.
4 1 Introduction

1.2.4 Language

In this book, we focus on English as it is the most widely used scientific language,
but the principles we cover are universal, irrespective of the language you use for
producing a document.
Many scientists like using complicated and impressive scientific jargon, forgetting
that the people they communicate with do not necessarily have the same scientific
expertise and might not be proficient in the language they use. In general, the
language you use should be simple, correct, clear, and unambiguous. A helpful
principle is to use simple words and keep sentences short. You might communicate
with regulatory authorities, for example, where most of the staff members are
nonnative English speakers. For them, English might be a second, third, or even
fourth language. I once heard a politician speak about the first exposure of the young
mind to the formal educational process. He meant when children start going to
school, but for nonnative speakers, this may not have become clear at once. Sloppy
and overblown language will plant the seeds of doubt in the readers mind; they may
ask themselves whether the scientific work underlying the document may have been
as careless as the language used to describe the findings. Thus, the credibility of your
medical/scientific message may be jeopardized on the grounds of sloppy language.

1.2.5 Tools

We live in an age of computers, information technology, and the Internet. Proficient


medical and scientific writers must be computer-literate and should be able to use
appropriate word processing tools, graphics packages, data analysis tools, and
reference managers. They should be able to do literature searches, find guidelines,
and communicate rapidly and efficiently while linking and managing literature
references. At the same time, you should be selective and avoid information overload
that may result from the ease of data access. A PubMed search might identify
hundreds of references on a particular topic within minutes. Make sure that the
references you select are relevant and add value to your main messages.
Figures, graphs, and tables (see Chap. 8) are powerful tools for projecting key
messages and summarizing large datasets. Simple illustrations of concepts (as used
in Figure 1.1, for example) are helpful in conveying the intended message in a
concise way.

1.3 How to Plan a Document

Your planning is driven by strategy. Assuming that you work with solid data, your
chances of success will be determined by the way you manage the key elements as
discussed below.
1.3 How to Plan a Document 5

1.3.1 The Nature of the Document

The major determinant of how you will proceed is the nature and purpose of the
document you aim to produce. Many types of documents are integral parts of the
drug development process, such as the Investigational New Drug (IND) document,
Investigational Medical Product Dossier (IMPD), Investigators Brochures (IB),
study protocols, study reports, the Common Technical Document (CTD),
publications in a scientific journal, etc. Once you know the type of document you
need to write, the following are key considerations:

1.3.2 The Desired Outcome

Successful medical/scientific writing should always be outcome-driven. Examples


of the desired outcome include the approval of a CTD for marketing by a regulatory
authority, acceptance of a paper for publication by a reputable medical journal, or
preparation of an IB ensuring the conduct of a good clinical study by the principal
investigator and supporting staff. The required outcome determines the content and
the format of the particular document.

1.3.3 Guidelines

If you work for a pharmaceutical company, there will be internal guidelines and
templates for documents such as study protocols and reports. The current guidance
documents of regulatory authorities are readily accessible on their websites. Before
starting to write a document, you should familiarize yourself with the appropriate
guidelines. Sometimes you will find that you need to deviate from a regulatory
guideline because it does not entirely fit your situation. This is fine, provided you
make the deviation clear upfront and can justify your approach. It is also important
to decide whether your document is a final document, such as a final study report,
or a living document, such as an IB, where changes should be made as new
information becomes available. A good medical/scientific writer will not only add
new information but will also remove information that has become irrelevant to
prevent the document from becoming too large and difficult to read.
A common mistake is the urge of some authors to write something under a
particular heading at all cost. If no clinical data are available at the time you are
writing an IB (see Chap. 10), Section 7.3.6 of the ICH guideline (Effects in
Humans) should not include any speculation on what may be found, but should
merely contain a simple statement that no data in humans are available at the time
of writing the document.
6 1 Introduction

1.3.4 Target Audience

Your target audience may vary greatly. For example, the audience may include
employees of regulatory authorities (with varying backgrounds in terms of scientific
and/or medical training), ethics committees (which usually include lay members,
people with legal background, scientists, and clinicians), or journal editors and
reviewers. It is imperative to consider the background of the target audience in
choosing the appropriate style of language and the use and explanation of scientific
and clinical terminology. A sentence such as Deposition of hydroxy apatite in the
intima, irrespective of the presence of atheromatous changes, impacts on vascular
compliance and tissue perfusion might be fine for a clinician, but for a lay person in
an ethics committee, a more appropriate sentence would be: When calcium crystals
form on the inner surface of blood vessels, the blood vessels may become stiff and
hard or blocked, and this can decrease the blood supply to important organs.

1.3.5 Key Messages

The key messages should convey the essential information needed to convince the
responsible person(s) to make a decision in line with your desired outcome. For
example, when compiling an IND application for the first study in humans, you
would primarily like to tell the regulatory authority that you have sufficient and
convincing nonclinical data to justify a study in humans and that all potential safety
issues are addressed in the proposed protocol.

1.3.6 Sources of Information

Most documents written in a pharmaceutical industry setting contain proposals


based on medical/scientific data. Such data may come from the public domain
(mainly from scientific or medical publications) or from in-house research. To write
a good document, you must be thoroughly familiar with the data supporting your
arguments and proposals. It is crucial to not only provide favorable data but to also
identify unfavorable issues, put them into context, and indicate how they will be
addressed. A good medical writer will strive to find a balance between providing too
much information and skipping important information.

1.4 Using a Template

Using a suitable template (Table 1.1) helps you to compile a document that follows
a logical train of thought and covers all important issues. The template we
recommend resulted from years of trial and error. In our experience, the template
1.5 Final Thoughts 7

Table 1.1 Template for the planning of documents


Document Identify the type of document you are planning to write (e.g., study report,
IB, or manuscript for publication)
Outcome Clearly state the optimal desired outcome (e.g., acceptance of publication in
an appropriate journal that will impact on the prescription patterns of
cardiologists)
Guidelines Identify and consult the appropriate guideline (e.g., FDA guidance on IB)
Target audience Identify and consider the background of the target audience (e.g., informed
consent documentation for participants in a clinical trial should be written in
a language that will be understood by lay people)
Key messages Identify the key messages (they should be based on solid scientific/medical
knowledge) that will convey the information to the decision makers and
achieve a desired response (e.g., approval of a pivotal trial protocol by a
regulatory authority)
Information The main sources in the context of medical/scientific writing would be data
sources from the literature and from previous work performed by the sponsor

facilitates and simplifies the construction of high-quality documents. The template


can also be used for the preparation of oral presentations and accompanying visuals.

1.5 Final Thoughts

We hope that your journey through this book will be pleasant and informative and
that sharing our experience with you will help you to optimize your communication
skills, both verbally and in writing.

Exercise
Before proceeding to the next chapters, try to compile the following document
templates:
A scientific publication: You are working for a company that has developed
a novel antihypertensive drug (use your imagination to create a target
profile), and the CTD has been submitted. Your target prescribers will be
general practitioners and you would like to establish your drug as first-line
therapy. You have the data from two major pivotal studies in patients with
mild to moderate essential hypertension. Plan a scientific publication that
will be complimentary to your marketing campaign.
An IB
A study protocol
A study report
Retain these templates while reading the book and repeat the exercise
when you have finished, without looking at your first set of templates. Then
compare. Have fun!
Chapter 2
Written Communication in Drug Development

The single biggest problem in communication is the illusion that


it has taken place.
George Bernard Shaw

2.1 Where Is Written Communication Used in Drug


Development?

Written communication in drug development plays an important role on several


levels, including:
Recording new findings from nonclinical studies
Preparing documents needed within the drug development process (IND, IMPD,
IB, clinical study protocols, clinical study reports, CTD, etc.)
Communicating with regulatory authorities, ethics committees, and other
important groups
Drafting publication manuscripts in connection with the drug in development
The data communicated at these various levels differ in terms of their nature,
terminology, and complexity. Moreover, the audience to be reached by the various
documents changes during the course of drug development, which necessitates
considerable sensitivity on the part of the writer. Scientific/medical information
should be presented in a manner that can be understood and interpreted by the
targeted audience.
Consequently, a good writer must be able to anticipate the level of understanding
of the intended readers. There is no point in overloading the nonclinical scientist
with unnecessary marketing information, nor would the clinical investigator benefit
from excessive technical details on the synthesis of the drug under study. Thus,
good writing additionally entails careful planning of the level of detail required for
the intended audience.

Springer-Verlag Berlin Heidelberg 2015 9


P.H. Joubert, S.M. Rogers, Strategic Scientific and Medical Writing:
The Road to Success, DOI 10.1007/978-3-662-48316-9_2
10 2 Written Communication in Drug Development

2.1.1 Recording Nonclinical Findings

Imagine what happens with your experiments or studies if you fail to record their
outcome in writing. No one would know of your important findings, and it will be
almost impossible to prove to others that you had actually carried out the research.
Painstaking efforts and elaborate work may be lost, simply because there is no
written account of them. Essentially, nonclinical findings form the basis of future
studies in humans.
It follows that written communication in drug development is of critical
importance. For this reason, it should be our main concern to document new findings
efficiently, effectively, and truthfully. A concise summary of the documents written
during the preclinical stages of drug development is provided by Rogge and Taft [1].

2.1.2 Preparing Drug Development Documents

As pointed out in Chap. 1, the drug development process encompasses many types
of documents, such as IBs (Chap. 10), INDs and IMPDs (see Chap. 11), CTDs (see
Chap. 12), study protocols (see Chap. 13), study reports (see Chap. 13), and
manuscripts intended for publication in a scientific journal (see Chaps. 3 and 14).
In drug development, failure to document our findings inevitably results in delays
in obtaining marketing authorization of a new drug. This translates into substantial
sums of money being lost by the sponsor company.

2.1.3 Communicating with Regulatory Authorities and Other


Important Institutions

Nowadays, the drug development environment is highly regulated. Moreover, it may


take as many as 10 years to develop a new drug, although the pharmaceutical industry
and health authorities have been working hard at reducing the long development
times. Ideally, initial contact with the authorities should take place even before
applying for an IND. Recently, the FDA assessed the development times of new
drugs that were approved with the benefit of pre-IND meetings and compared them
to the development times for drugs that were approved without such meetings [10].
The findings underscore the value of early communication. Average clinical
development times of new drugs for which a pre-IND meeting between the drug
developer and FDA was held were substantially shorter than those of other drugs. For
instance, average clinical development time for all new drugs approved between
2010 and 2012 was shortened by >3 years when a pre-IND meeting was held [10].
2.1 Where Is Written Communication Used in Drug Development? 11

Although many factors influence the speed and efficiency of a drug development
program, the value of effective communication during the drug development and
approval process is unquestioned, especially for the development of novel
medications for which regulatory guidelines have not yet been established [10].
While early consultation with the authorities is indispensable, other bodies relevant
to the target indication may have to be addressed. Such consultations should,
however, only be undertaken when the pertinent medical and drug information data
are available.
The FDAs Center for Drug Evaluation and Research (CDER) typically approves
more than 100 new medications every year. In 2014, as many as 41 of the newly
approved agents were novel molecular entities or new therapeutic biologics, which
is considerably more than in previous years [11]. Many of these new drugs are
expected to make a significant contribution to the management of serious or
life-threatening diseases. In addition, an exceptionally large number of drugs
(n = 17) to treat so-called rare diseases were approved in 2014. This achievement is
of particular merit because there are often no (or insufficiently effective) drugs
available to treat diseases occurring in small populations.
Early and regular communication between drug developers and health authorities
allows the authorities to apply tailor-made review and approval procedures, with the
aim to ensure the fast availability of important new medications. In the USA, such
regulatory procedures include Fast Track, Breakthrough Therapy, Priority Review,
and Accelerated Approval [11]. Fast Track and Breakthrough Therapy designations
are intended for drugs to treat serious conditions with unmet medical needs, while
Priority Review is granted for drugs expected to provide a significant advance in
medical care. For such medications, CDER shortens their review period from 10
months to 6 months. The Accelerated Approval program allows early approval of
drugs to treat serious or life-threatening illnesses for which less effective treatments
are available. In these cases, approval is based on a surrogate endpoint (e.g.,
laboratory value or biological marker) or intermediate clinical endpoint that is
thought to be reasonably likely to predict clinical benefit [11]. After approval of
such drugs, additional clinical studies are usually required to confirm the predicted
clinical benefit [11].
There are special areas where there are timeline and/or financial incentives to
encourage drug development:
Obtaining orphan drug designation encourages the development of drugs for rare
diseases. Incentives include free advice and possible acceptance of innovative
study designs.
Pediatric population: Many adult diseases have a small subpopulation in
pediatric patients (e.g., rheumatoid arthritis, essential hypertension, type II
diabetes). The FDA encourages pediatric studies as part of drug development
in adults by offering an additional 6 months of marketing exclusivity, for
example.
12 2 Written Communication in Drug Development

2.2 Final Thoughts

Early contact with the regulatory authorities helps to expedite the development
process, and regular communication between the authorities and drug developers is
instrumental in streamlining the review of new products. Thus, health authorities
encourage regular exchange with drug developers and are usually prepared to
provide guidance at an early stage. Responsible professionals in the pharmaceutical
industry should make use of this opportunity; in this way, issues in connection with
manufacture, formulation, and/or testing of the new drug candidate can be addressed
at an early stage, thus preventing unexpected delays.
Chapter 3
Written Communication in Academic Settings

The more elaborate our means of communication, the less we


communicate.
Joseph Priestley

3.1 Where Is Communication Used in the Academic Setting?

The primary purpose of universities and other research-oriented institutions is to


transfer and disseminate knowledge. While students write to explore topics and
become familiar with what is known about them, it is the duty of every scientist to
share any new findings with the scientific community, in an effort to advance the
existing knowledge pool. In this way, the writing produced in the academic setting
aims to educate the next generation of scientists.
Good universities are those whose research performance, as measured by the
number of publications and citations per year, is excellent. Although the various
systems applied to rank the quality of universities employ variable criteria, academic
excellence and research performance are always among the main factors. Some
ranking systems, e.g., the Academic Ranking of World Universities (ARWU; www.
shanghairanking.com), do not only rate the number of publications produced but
specifically focus on the number of articles published by the prominent journals
Nature and Science.

3.2 Scientific Papers

As pointed out in Chap. 14, publishing data in medical and scientific journals is the
most important means of communicating research results, both in the academic and
commercial settings. In either environment, authors are faced with the main three

Springer-Verlag Berlin Heidelberg 2015 13


P.H. Joubert, S.M. Rogers, Strategic Scientific and Medical Writing:
The Road to Success, DOI 10.1007/978-3-662-48316-9_3
14 3 Written Communication in Academic Settings

questions, namely, why they wish to publish, what journal should be chosen, and
how they are going to unveil their scientific story.
While the reason for publishing in the commercial setting is usually connected
with marketing strategies, academic publishing primarily aims to advance scientific
and medical knowledge. In the academic environment, the publishing procedure is
usually less regulated than that in the commercial environment where company
policies oversee the publication strategy (see also Chap. 15). Thus, academic
researchers bear sole responsibility for their publishing efforts a fact that can be
an advantage or a disadvantage.
Chapter 14 provides detailed guidance on the planning and preparing of a
scientific manuscript intended for publication.

3.3 Theses and Dissertations

3.3.1 Masters Thesis/Dissertation

For many students, the masters thesis (also referred to as masters dissertation)
represents the first attempt at writing a formal scientific document. Although the
Internet supplies ample advice on how to write a thesis and universities tend to
supply good templates, most students face a major challenge when embarking on
their masters thesis. They are aware of the importance of this document in that it
represents the formal product of their studies, on the basis of which their
performance and achievements can be assessed.
Ideally, the masters thesis is written in a manner that renders it suitable for
subsequent publication in an appropriate scientific journal. For scientists, the
publication track record is of fundamental importance, and the sooner they can
establish themselves in the scientific community, the better are their chances of
advancement. However, not all masters projects are suitable for eventual publication,
and this may not necessarily reflect on the students ability to address a scientific
question. Some projects simply do not deliver publishable results, or they just form
a part of a larger study that will be published by other authors. Students whose
masters projects involve collaboration with a pharmaceutical company may
additionally be faced with confidentiality issues that prevent them from making
their findings available to a broader audience.
In any case, the masters thesis has to meet high standards in terms of contents,
format, and writing style, but there is no general consensus on how to present and
structure the data. The type of structure chosen depends primarily on the nature of
the study, as well as on guidelines and example documents provided by the university
or other institution at which the research was conducted. If the outcome of a masters
project is suitable for publication, the structure of the manuscript is essentially
guided by the specific author instructions of the chosen journal. Most journals
3.3 Theses and Dissertations 15

follow the classic IMRAD structure (an acronym based on the first letters of
Introduction, Methods, Results, and Discussion), or a modification of this. For
example, Introduction may be replaced by Background, Methods by Procedures,
and Results by Findings. Clearly, this simplifies the task of writing a masters thesis
to some extent because author guidance tends to be concise, and novice writers can
consult examples of papers published by the journal in question.
If you do not intend to publish the data generated within the study for whatever
reason, the thesis should be written in the form of a book consisting of chapters.
Although the number and nature of chapters depends on the specific research project
and extent of information accumulated, the structure suggested in Table 3.1 can be
applied to most situations.
In a section placed before or after the main text, you may wish to acknowledge
any help you have received during the studies. This may include supervisory efforts,
laboratory assistance, statistical help, or even editorial support.

3.3.2 Doctoral Dissertation/Thesis

The doctoral dissertation (also termed doctoral thesis) constitutes a more extensive
treatise than the masters thesis, reflecting the prolonged research period involved.
Commonly, doctoral projects last at least 3 years; occasionally, they can take
considerably longer. If funding of the project is limited to 3 years (as is typical in
certain countries, e.g., the UK), students and supervisors have a vested interest to
complete the studies within a reasonable time frame. However, funding for a limited
time period may put students under undue pressure to complete their studies more
quickly than would be appropriate to solve the research question. Such constraints
are liable to mislead students into careless or even sloppy work, which severely
impinges on the quality and credibility of the generated data. Even worse, students
may be tempted to falsify results or copy data from other authors, thus making them
guilty of plagiarism (see Sect. 6.3.3).
The doctoral dissertation constitutes an exposition of original research and
should reflect not only mastery of research techniques but also ability to deal
competently with an important research question. In addition, the writing of a
doctoral dissertation challenges your skills as a scientific communicator. It would be
unforgivable to present your hard-earned results in a dissertation that is difficult to
read and understand. As is true for any type of scientific treatise, the doctoral
dissertation aims to inform rather than confuse the reader. Although writing a
doctoral thesis may be a daunting task, it is perhaps the most important investment
into your future as a scientist. It will be a passport to acceptance into the scientific
community, and the nature of your work will set the scene for your future scientific
endeavors. For these reasons, it is more than worth your while to invest sufficient
time and energy into the completion of your thesis.
Table 3.1 Suggested structure of a masters thesis
16

Title page Use the format suggested by you institution


The title page (one page only, not numbered!) should indicate that the document is a masters thesis and should include the
title of the study, author details (i.e., your name, current degree such as B.Sc., and affiliation), as well as the date of release.
Most universities also require supervisor details
A formal statement is commonly required, e.g., Submitted in partial fulfillment of the requirements for the degree of
Master of Science or Research project submitted in partial fulfillment of the requirements for the degree of Master of
Science
Abstract Provide a brief (usually 250 words) abstract using IMRAD, in line with the main part of the thesis
Make sure the most important findings (including numerical data, e.g., percentages and p-values) appear in the abstract
Chapter 1: Background or Describe the rationale behind your project. Why did you embark on this research project?
Introduction Summarize what is known already by crediting the relevant authors (see List of References, below)
Do not reveal any of your new findings in the Introduction
Chapter 2: Literature Review This chapter should only be added if you have reviewed the literature supporting your research question. If the existing
3

literature is limited, include a summary in Chapter 1


Chapter 3: Methods and This section should detail all methods used during the study, including statistical methods and data analysis. Some
Materials templates foresee a separate section for data analysis, but this may not make sense for your specific project
Provide sufficient and accurate information that would allow other scientists to apply your methods to their own work or
repeat experiments that you have conducted
Chapter 4: Results Summarize your results, using sensible subheadings that allow readers to quickly find the information they are looking for
Use tables for numerical findings and graphs for developments, trends, progress, etc.
Chapter 5: Discussion and Discuss your findings in a qualitative sense, elaborating sensible explanations for them
Conclusions Do not over-hypothesize if there is no plausible explanation
Place your findings in the context of what is already known, giving credit to those who reported any previous findings (see
List of References, below)
Chapter 6: List of References List all references cited in your thesis, using an accepted format (as suggested by your institution or formatted automatically
or Bibliography by a reference manager tool)
The reference format should be used consistently throughout
Chapter 7: Appendix Include any additional materials, such as raw data, detailed method descriptions, randomization codes, tables and figures
Written Communication in Academic Settings

not included in the main part, etc.


3.4 Other Student Papers 17

While in former times, a doctoral thesis followed roughly the same format as the
one used for a masters thesis (see Table 3.1), a more popular approach nowadays is
to structure it as a series of articles suitable for publication in scientific journals. As
pointed out in Sect. 3.3.1, scientific endeavors live from sharing information and
contributing to the knowledge pool. Moreover, a scientists success hinges on his
or her publication track record, and early visibility in the scientific community is
clearly advantageous. Moreover, the thesis structure based on individual manuscripts
spares students the effort of having to write the thesis and articles for publication
separately. Nonetheless, not all universities support this approach, and your
institution and/or supervisor will have to advise you on this.
The Internet provides ample advice on the preparation of a doctoral thesis, but
the most appropriate inspiration usually comes from good examples written by
members of your group or department. There is no hard and fast rule on the
composition, contents, and structure of a doctoral thesis; you are the author and the
expert!

3.4 Other Student Papers

3.4.1 Laboratory Reports

For most science students, the writing of a laboratory report constitutes their very
first attempt at presenting data in a structured and logical manner. Therefore, it is
not surprising that the quality of laboratory reports ranges from clumsy compilations
of methods and materials to rather sophisticated scientific papers. Universities and
other research institutions often provide insufficient advice for novice writers, thus
leaving students alone with a difficult first encounter with scientific communication.
This effort may be additionally impeded by language hurdles; most laboratory
reports are written in English, but this may not be the native tongue of the author
(see also Chap. 5).
Although laboratory reports are written for several reasons, the main reason in all
cases is to communicate the experimental work to your instructor, supervisor, or
other interested reader. Without the written record of your laboratory experiments,
there is no proof of your findings, and your efforts may be lost forever. Much
unnecessary time goes into repeating laboratory experiments if we fail to archive the
work. In the pharmaceutical industry, such deficiencies translate into serious delays
in the development of new drugs and unnecessary (and costly) prolongation of the
time to market.
Like all scientific expositions, laboratory reports should be brief, concise, and to
the point. This may be easier said than done; inexperience and language problems
invariably lead to wordiness and redundancies. Students are often tempted to
compensate for their lack of expertise with inappropriate detail and awkward
descriptions, thus making it hard for the reader to work out the story. A useful tip
is to rely on short sentences and commonly known words rather than obscure terms
18 3 Written Communication in Academic Settings

Table 3.2 Suggested structure of a laboratory report


Introduction State the reason(s) for performing the laboratory work, e.g., student practical,
method validation, student exercise, etc.
State the hypothesis that underlies your research question (if available)
Place your undertaking into the context of what is already known about the
topic
Methods and Describe all methods, including data analysis
Materials Do not overload this section with unnecessary detail but provide sufficient
information to allow other scientists or students to reproduce your work
Results State your findings in an appropriate form (tables for numbers, figures for
trends, etc.), but avoid reiteration and duplication
If you list your results in a table, you should not additionally describe them in
the text
Discussion Discuss your findings in the light of your hypothesis (if available). Has the
anticipated outcome been proven right or wrong?
Which additional experiments may be useful/necessary?
Conclusions Briefly (no more than a couple of sentences or bullet points) state what can be
learned from your work
Appendix Include any additional materials (if available), such as raw data or tables and
figures not included in the main part

that are not understood by your readers. A good laboratory report lives from clear,
transparent, and logical messages that can be grasped on first reading!
Structural organization of a laboratory report is dictated to some extent by the
nature of the experimental work, but the conventional IMRAD (see also Sect. 3.3.1)
is, at least, a good start. Table 3.2 provides a suggestion for organizing your report
if the IMRAD structure can be applied.

3.4.2 Research Proposals

Research proposals may be written at various stages of your scientific career. Here,
we focus on those you may have to write early on in your development as a scientist,
e.g., when elaborating a scientific question for your masters or doctoral studies.
A research proposal does not only aim to sell the research project; it additionally
serves as an advertisement for your capability as a scientist and scientific
communicator. You may have an impressive research idea, but if you fail to convince
the financial sponsor and/or your project supervisor(s), the proposal is likely to be
turned down. On the other hand, a well-prepared proposal may stand a good chance
of being approved even if the research idea is not groundbreaking. The quality of
your research proposal depends not only on the quality of your proposed project, but
also on the quality of your proposal writing. Therefore, the writing should be
coherent, clear, and compelling.
3.4 Other Student Papers 19

Thus, a research proposal is intended to convince the relevant individuals of your


research idea as well as of your skills and work plan to pursue it. Regardless of your
research area and the methods you choose, the research proposal must address the
following questions:
What do I plan to accomplish?
Why do I want to pursue this research idea?
How will I tackle it?
In that respect, a research proposal is not unlike a scientific paper (see Chap. 14)
or thesis (see Sect. 3.3). The story your research proposal aims to share should be
based on a logical train of thought, just like a scientific paper or thesis is based on a
clear-cut concept and accurately phrased narrative. Like scientific articles, research
proposals have sections describing the research background, significance, methods,
and references.
There are, however, some distinct differences:
The research proposal is written in the future tense because the work is planned
rather than completed at the proposal stage.
There are different points of emphasis. For example, the method section of a
research proposal tends to be considerably more detailed than that of a scientific
paper to allow the financial sponsor of the study to assess the expenses involved.
Statistical plans and randomization procedure (if applicable) must be explained
in full.
Research proposals do not contain any results but describe the hypotheses and/or
expected results.
A typical research proposal includes an extensive but focused literature review.
A research proposal may also include preliminary results.
Research proposals usually contain the curriculum vitae (CV) of the applicant(s).
This confirms that the responsible researcher(s) is/are capable of conducting the
research they propose.
In some academic institutes, a detailed rsum of the project supervisor(s) is
required.
Bearing in mind that spelling mistakes are annoying and distracting to the reader
and may even jeopardize the credibility of your proposal, pay careful attention to
grammar, spelling, and typos. Use a clear writing style, based on short sentences, words
with clear meaning, and active voice where possible. It may be useful to ask a competent
scientific writer to proofread your proposal and to get an experienced academic to
ensure that the proposal conforms to institutional and international academic standards.
Sometimes, the research proposal forms part of an application for ethics approval
required for studies in humans or studies involving human tissue. Below, we
summarize the most important aspects of preparing an application for ethics
approval.
Table 3.3 shows the structure of a typical research proposal.
20 3 Written Communication in Academic Settings

Table 3.3 Suggested structure of a research proposal


Title page List personal data (name, academic title, your position, contact
information)
Give a brief but clear title of your planned research. The title should be
no more than 10 words (60 characters) and should include the key
words to reference the classification of the research subject
If required, state the name(s) of your supervisor(s), the university
department where you hope to do your research, and, if applicable,
information about other academics with whom you plan to collaborate
Abstract or summary This one-page summary focuses on the relevant aspects of the
of the project proposed research
Literature review Provide an overview about the current state of research connected with
your project
Reference the most important contributions made by other scientists
Indicate the unanswered question(s) forming the basis of your proposal
and stress their significance
Your history/ Summarize the most important impact of your own work on the topic
preparation (if applicable). If available, attach copies of your own publications
relating to the research project
Objectives of the Give a concise outline of the academic (and other, if applicable)
research project objectives
Outline the significance and/or relevance of the topic
Outline of the project Detail the planned research procedure
List sources of evidence you will consult, the analytical technique you
will employ, and the timetable you will follow
Depending on the topic, suitable research strategies should be defined
to ensure that enough and adequate empirical data will be gathered for
a successful research project
Describe the intended methods of data gathering, the controls you will
introduce, the statistical methods to be used, the type of literature or
documentary analysis to be followed, etc.
Timetable Develop a time table (if possible in table form or flowchart), indicating
the sequence of research phases and the time that you will probably
need for each phase
Selective research List all references mentioned in your research proposal as well as other
bibliography important literature
Attachments Attach any additional materials, such as CVs, references, etc.

3.5 Application for Ethics Approval

Research projects involving human participants, personal data, or human tissue


have to be approved by the responsible ethics committee (EC) before the study is
initiated. This applies to nonclinical as well as clinical studies (see also Chap. 13),
regardless of whether the study will be conducted at a university or external facilities.
3.6 Grant Applications 21

The EC, also termed Institutional Review Board (IRB), is an independent


organization consisting of healthcare professionals and nonmedical members,
whose main responsibility is to protect the rights, safety, and well-being of humans
involved in a clinical study. The EC evaluates the study protocol in terms of its
scientific rationale and ethical considerations, but also assesses the suitability of the
investigator(s) and study facilities involved. Moreover, an important task of the EC
is to ensure that all documents written for study participants are clear, accurate,
truthful, and complete. Potential study participants have the right to know all
implications and consequences of their participation, and they need to be fully
aware of every aspect of the study before giving their informed consent. In some
cases, this requires that patient information documents have to be translated into
various languages.
Ethics approval can be obtained via a number of possible routes, depending on
the nature of the study. For research involving the use of human tissue, there are
specific legal and regulatory requirements. When deciding on the appropriate
procedure for obtaining EC approval, the responsible researchers(s) should consult
the guidelines of their local EC and seek early interaction with its members to
ensure that all necessary information and documents are available.
The process of obtaining ethics approval can be time-consuming and nerve-racking.
Often, much time is lost at this early stage because applicants are insufficiently well
informed of what is required for the planned study. To expedite this procedure, consult
someone who has experience with applications for ethics approval at an early stage.
And remember a favorable decision on the part of the EC hinges on the scientific
logic and persuasiveness of your proposal, but also on the clarity and completeness of
the documents supporting it.

3.6 Grant Applications

In the academic setting, grant applications play an important role at various stages
of a scientists career. The earliest encounter with grant applications may even be
before you enter university if you apply for a study grant. Here, we are primarily
concerned with applications for research grants, although the points made may
apply to other grant forms as well.
Why would you want to write a grant application as a researcher? Most of us are
aware that grant applications are hard work, demanding, laborious, and time-
consuming so why would anyone invest their precious time into such an
undertaking?
The answer is obvious: research is costly, and university funds are limited. Thus,
academic institutions depend on financial support from other sources. As pointed
out in Sect. 3.2, advancement and success of a researcher primarily depend on his/
her publication track record, and how can you publish in the absence of data? In
other words, grants enable you to pursue an interesting research question that you
could not have addressed without financial support.
22 3 Written Communication in Academic Settings

When applying for a research grant, you are expected to hand in a detailed and
precise description of the planned study or research proposal, as well as any previous
studies or other information of particular relevance to your project. It is also useful
if you include a realistic budget proposal. Your application for funding should
convince the sponsoring organization that your scientific question is of interest to
the scientific community and that you are able to answer the question on the grounds
of your training, experience, and technical facilities. Moreover, the proposal should
entail a realistic time frame and reasonable expenses. Open-ended proposals tend to
be suspect in the eyes of reviewers as it will be difficult to estimate the overall
costs.
A grant application that stands a reasonable chance of being successful must
fulfill a number of criteria. First, the research topic in question must be creative,
novel, and of interest to the scientific community as a whole. Second, your
experimental plan must be realistic, sound, and compelling. Finally, you must make
sure that the information is organized in a logical structure and that the wording of
your text is clear, unambiguous, and free of language mistakes. As with all good
writing, a grant application stands the highest chances of being successful if you are

Table 3.4 Questions asked by reviewers of grant applications


Merits How high are the intellectual value and potential merits of the
project in question?
Impact How high is the expected impact? How much new knowledge is
likely to be added?
How many individuals, groups, or institutions, etc. would
potentially benefit from the study outcome?
Novelty of the project How novel is the proposed work? If not novel, to what extent does
potential impact overcome this lack?
Is the research likely to produce new data and concepts or confirm
existing hypotheses?
Hypothesis and evidence Is the hypothesis valid?
Have you presented sufficient evidence in support of it?
Logic and feasibility of Are the aims logical and realistic?
aims Can the proposed aims be reached within the period for which the
grant is being sought?
Appropriateness of Are the methods and procedures appropriate, adequate, and
methods and procedures feasible for the research?
Could less costly alternatives be suggested?
Investigator qualification Is/are the grant applicant(s) qualified to perform the study as
proposed?
What evidence is there to document their expertise in the field?
How much previous work has gone into clarifying the importance
of the research question?
Suitability of research Does the research facility stand up to quality checks?
facility Does the suggested project fit in the facilitys general research
interests?
3.7 Final Thoughts 23

able to anticipate the reviewers questions and work around them. Table 3.4 list the
most pertinent issues reviewers tend to bring up.
The format and extent of your proposal may vary, depending on the complexity
of the proposed topic and the level of detail expected by the sponsoring organization.
If guidelines for the specific grant application are available, make sure your
document complies with them in full. Many organizations provide forms and
templates that facilitate the process of completing a grant application. In the absence
of such guidance, your best bet is to use a layout similar to that suggested for a
research proposal (see Sect. 3.4.2). In addition, it is good advice to consult an
internal advisor with experience in writing successful grant applications. Bearing in
mind that you are asking for something (i.e., financial support), a favorable decision
on the part of the jury or selection committee is much more likely if your proposal
is enticing, legible, and well structured.

3.7 Final Thoughts

In both their learning and teaching roles, members of academic institutions have to
pay great attention to the quality of their texts. Poorly written or disorganized
student papers will hinder the advancement of the student, and manuscripts, research
proposals, or grant applications whose contents, structure, or style are deficient will
not be approved.