1

Systematic Review on clinical trial

participants: Indian perspective

M. Sc. Thesis Report (2008-2010)

Submitted to
Institute of Clinical Research, India (ICRI)

&
Cranfield University, UK

Submitted by:
Machut Zimik
D-1017
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DECLARATION

I hereby declare that the thesis work entitled “Systematic Review on Clinical Trial Participants:

An Indian Perspective” submitted to the “Cranfield University” and “Institute of Clinical

Research India” is a record of an original work done by me under the guidance of Professor Phil

Warner (Cranfield University) and Dr. Amit Kumar Verma (Institute of Clinical Research India).
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ACKNOWLEDGEMENT

Firstly, I must thank my mentor Dr. Amit Kumar Verma for his continuous support and guidance

throughout my academic programs. Without his constant support and inputs I could not have

finished this thesis.

I would also like to thank Professor Phil Warner for his valuable expertise and pointers which

helped me immensely to frame my thesis work appropriately.

Last but not least a special thanks to all my friends and family for their support and prayer which

enables me to complete my thesis effectively and on time.

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ABSTRACT

The globalization of clinical trial has substantially increased the participation of India thereby

becoming one of the hotspot destinations for conducting global clinical trial sites. At present,

India being one of the fastest in patient enrollment rate , certain ethical concerns has been raised

fearing that the cultural and socio-economic background are exploited to enhance the research

programs. There is clearly a large knowledge gap between the researchers and the potential yet

vulnerable participants. With a large number of people now participating in a clinical trial, it is

important to determine their willingness to participate in a clinical trial.

The reviewer conducted a systematic review of all studies that emphasize on the contributing

factors and barriers on trial participants within the Indian populations. An online database was

searched both International as well as Indian journals. The study included in the final analysis

dealt exclusively with only Indian population participating in a clinical trial. Data extraction and

validation was conducted by the reviewer alone.

The final evaluation comprises of five qualitative studies and two surveys. The themes included

in the participants favoring factors include personal benefits, social benefits; generate extra

income, knowledge associated with the trial, motivating methods for participation and physicians

while themes acting as barriers for participation include logistical problem and misconception,

concern about the treatment, fear, confidentiality issues, psychosocial factors and mistrust

towards sponsors.

Factors that facilitate participation and factors that act as barriers among Indian subjects were

identified by the reviewer. Before initiating a clinical trial it is important to consider patient’s

perspective on participation and accordingly plan for any future implementation.

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CONTENTS

Declaration ……………………………………………………………………… 2

Acknowledgement ……………………………………………………………… 3

Abstract …………………………………………………………………………. 4

1. Introduction...………………………………………………………………...7-8

2. Literature Review

2.1. Systematic Review……………………………………………………...9

2.1.1. Importance of Systematic Review………………………………..9-10

2.1.2. Appraisal of Systematic Review………………………………….10-13

2.2. Patient recruitment……………………………………………………….13-14

2.2.1. Difficulties faced in recruitment process…………………………14

2.2.2. Reasons of patient participation in clinical trial…………………..14

2.2.3. Roadblocks to patient participation in clinical trial……………….15

2.2.4. Background on clinical trial participants………………………….15-16

2.2.4.1. Indian scenario………………………………………………..16-17

2.2.4.1.1. Advantages of conducting clinical trial in India……….17

2.2.4.1.2. Factors affecting patient recruitment in India…….........18-20

2.2.4.1.3. Rationality of the study ………………………………..20-21

3. Aims……………………………………………………………………………22

4. Objectives………………………………………………………………………22

5. Research Methodology…………………………………………………………23

5.1. Defining Research Question……………………………………………….23

5.2. Ethical Approval……………………………………………………………23

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5.3.Selection of Studies………………………………………………………..23

5.4.Following keywords were used as a search strategy………………………24

5.5.Inclusion/Exclusion Criteria……………………………………………….24-26

5.6.Study Characteristics………………………………………………………26

5.7. Interpretation……………………………………………………………...26

6. Results …………………………………………………………………………27-29

6.1. Contributing factors that favor subject participation in a clinical trial……..30

6.1.1. Personal benefits……………………………………………………31-32

6.1.2. Social benefits………………………………………………………32

6.1.3. Generate extra income………………………………………………32-33

6.1.4. Knowledge associated with the trial………………………………...33

6.1.5. Motivating methods for participation ………………………………233

6.1.6. Physicians …………………………………………………………..34

6.2.Barriers to participate in clinical trial……………………………………….34-35

6.2.1. Logistical problem and misconception……………………………...35

6.2.2. Concern about the treatment………………………………………....35-36

6.2.3. Fear…………………………………………………………………..36

6.2.4. Confidentiality issue…………………………………………………36

6.2.5. Psychosocial factors………………………………………………….37

6.2.6. Mistrust towards trial sponsor………………………………………..37

7. Discussion………………………………………………………………………...38-47

8. Conclusion………………………………………………………………………..48-49

References ………………………………………………………………………………..50-53
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1. INTRODUCTION

It is estimated that an average of 6% of the entire clinical trial budgets are being spend on subject

recruitment strategy (advertising and marketing) by global pharmaceutical companies and

biotech sponsors (1). Notwithstanding the amount of this investment by pharmaceutical

companies about 86% of the clinical trial surprisingly does not meet recruitment expectation (1).

More than 80% of clinical trial fails to enroll subjects on time globally, which can amount to loss

of 85%-95% of days in a clinical trial (2). This has made subject recruitment one of the most

challenging aspects to the sponsors. India offers a numerous advantages to the sponsors because

it provides a large patient pool to facilitate faster recruitment rate, cost effective clinical trial,

world class hospitals and clinical research facilities besides availability of a highly qualified

professionals.

It is apparent that global clinical research is exploring in India in an exponential manner. The age

old technique of medical research begin long time ago in India since the two ancient scripts

Charaka Samhita (a textbook of medicine) and Sushruta Samhita (a textbook of surgery) written

as early as 200 B.C and 200 A.D. However, the current scenario in clinical research is

spearheaded by USA, UK and Japan after they jointly proposed the ICH (International

Conference of Harmonization) guidelines. After recognizing the potential to outsource clinical

trials in India because of certain advantages the growth of clinical research industry in India has

been expanding rapidly.

Since mid 1990 India started conducting International Clinical trial though it was until 2005 that

the regulation on clinical trials began to change rapidly. A report from a conference at the

Institute of Clinical research (India), Mumbai Oct. 2008 by DCGI stated that 582 registered
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clinical trials are being conducted in India (3). With more than 150 CRO’s and a number of

pharmaceutical companies now operating in India the rate of conducting clinical trials are very

much on the rise. It is apparent that India being a favored destination for conducting global

clinical trial the number of NDA is increasing in a large scale. This had eventually led to the

increase in recruitment of study subjects. Patient recruitment itself is a big challenge as it is with

Research and development. Pharmaceutical companies and CRO’s are now professionalizing in

recruitment activities to overcome the hurdles of missed deadlines, more cost and delay in

approval. The increased in the participation of multi-site studies has raised certain ethical

concern particularly on the study subjects fearing that their local customs, cultures and habits are

not respected by exploiting their economic status and leaving them no choice rather than forcing

them to participate in a study.

Unfortunately, the absence of affordable health care and poverty in India can be easily exploited

by CRO’s and pharmaceutical companies to enhance their research overlooking the integrity of

patients. It is estimated that approximately 5,300 subjects are required per NDA (4) and India

being 10 times faster in the rate of patient recruitment in contrast with US it is important to

identify the factors that led to patient participation in India. Conducting a systematic review on

the contributing factor of patient recruitment in India would serve as an ideal way of assessing

this attributes.
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2. LITERATURE REVIEW

2.1. Systematic Reviews

A systematic review is a scientific tool that can be used to appraise, summarize, and

communicate the results and implications of otherwise unmanageable quantities of research.

Systematic Review utilizes the availability of evidence and evaluates the number of studies

conducted separately to synthesize the result. Depending on the similarity of the studies

systematic review may or may not utilize meta-analysis (5). Meta-analysis is considered optional

components of systematic review.

Systematic Meta-
Review analysis

Meta-analysis is however a part of systematic reviews and involves statistical technique for

generating combining data to bring about a summary result. For the purpose of this thesis

systematic review will be use for the process of finding, selecting, apprising, synthesizing, meta-

analysis and interpretation of results.

2.1.1 Importance of Systematic Review:

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 Helps decision makers and healthcare providers summarize large amount of research-

based data/information

 Helps overcome bias among clinical trials and other research-based studies

 Helps resolve conflicts in results of several studies

 Helps to evaluate generalizability of conclusion

 Helps to overcome inadequate size of individual studies

 Conclusions can be drawn by considering all the available evidence

2.1.2 Appraisal of systematic reviews:

During systematic reviews, a conventional and rigorous methodology is developed to reduce

bias. Implementation of appropriate methodology for conducting systematic reviews and

minimizing bias during reviews can help enhance the appraisal of published articles.

Steps in developing systematic reviews:

I) Defining a research question:

This includes a thorough research on the related topics of interest and frame the

importance of answering a certain question that needs attention. The reviewer should

clearly state the question that needs to be addressed.

II) Selection Criteria:

Selection Criteria are considered depending on the clear question of the systematic

review such as population, intervention, age, ethnicity, outcome, etc. This will help as

a source of generating a set of inclusion and exclusion criteria of the study review.

Further it will determine if the searched literature can be assessed against the
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selection criteria of the study to be reviewed. The selection criteria must also reflect

on the objectives of the systematic reviews.

III) Searching the literature:

Searching a literature both from published and unpublished articles can be an

immense work and therefore should be carefully plan so that only the appropriate and

relevant studies could be searched. For instance, in systematic reviews of prevention

and treatment intervention, comparative randomized trials are most commonly used

to reduce bias. Depending on the interest of systematic review both electronic

databases as well as non-English sources can be searched.

IV) Assessment of included studies:

Assessing the selected studies is important in determining the validity of the searched

articles that needs to be included in the systematic review. Validity assessment should

be presented clearly.

V) Combining the results:

All the individual studies included in the review are aggregated to summarize the

overall effect of each study. In this step meta-analysis are utilized to analyze the

overall result of the included studies.

Meta-analysis is done in a two-stage process:

 Data extraction

 Calculation of result

VI) Interpretation:

The findings from meta-analysis are interpreted depending on the results of met-

analysis and further address the accountability of the findings.

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Defining a Research Question

Selection Criteria

Searching the Literature

Assessment of included studies

Combining the results

Interpretation

Figure 1 Overview of systematic reviews

Systematic reviews provide the best possible estimate among all other studies of any true effect.

A relevant clinical or any research question can be answered appropriately only if the systematic
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review are conducted with high quality and properly implemented. Gaining access to relevant

and reliable evidence could hugely favor on the outcome of systematic review. On the contrary, a

well conducted systematic review will immensely help the researchers, decision makers,

investigators, clinicians and practitioners.

2.2. Patient Recruitment

A successful completion of a clinical trial depends on the timely enrollment of patient

participants. A new molecules is expected to take 10-15 years to reach a market of which

30 percent of it are spend on recruitment of patients (6). Patient recruitment is therefore

considered as the “key bottle-neck” of clinical trial because it can either accelerate or

undermine the success of a clinical trial. The USFDA requires a minimum of 4,000

patients per drug to be tested so as to obtain for approval and marketing authorization.

Yet less than 5% of US populations are willing to participate in a clinical trial. This could

prove costly for the pharmaceutical companies since nearly 1 million dollars a day are

lost as revenue due to delay in gaining access to the market. A study by Rabo India

Finance ascertained that the cost of conducting phase I clinical trial in India is less than

half of the cost conducted in US while that of phase II cost almost 60% less.

Looking at the perspective of the companies cost effectiveness remains their prime

objectives and is looking towards countries like India and China where vast patient pools

are available. This has intensified competition within the pharmaceutical companies and

CRO’s which has made patient recruitment even more difficult. Currently pharmaceutical

companies are considering a major focus on patient recruitment strategy such as

identifying the demographics of the target population and other elements. As India is
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attracting more and more clinical trials it might face the same problem of patient

recruitment like in western countries such as US and Europe. The availability of a

suitable subject will reflect on the timely implementation of the study and further add as

incentives to the funding and designing of the study (7).

2.2.1 Difficulties faced in Recruitment Process

 Rare consideration of recruitment strategy during the protocol design

 Narrowly defined inclusion/exclusion criteria

 Inadequate budget allocations on recruitment process

 Lack of basic knowledge by Investigator on patient recruitment

 Negative publicity by the media

2.2.2 Reasons of patient participation in clinical trial

 Willingness to help advance knowledge

 Looking for a cure

 Lack of available therapy

 Better treatment

 Higher quality care

 Lack of health insurance

 Advice by personal or family physician

 Economic reason

 Received money for participation

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2.2.3 Roadblocks to patient participation in clinical trial

 Risk of side effects

 Language barrier

 Not eligible

 Psychological reason

 Inconvenient hours and trial center

 Trial burden

 Concern about getting placebo

 Fear of loss in confidentiality

 Mistrust of trial sponsor

2.2.4 Background on clinical trial participant

Currently there is a mixed opinion on why some study subject participates while others

choose not to participate. A survey from Harris Interactive Poll on cancer clinical trial

showed that, 83% of adults encourage the concept of clinical trials and considered

essential, however only 3% of US oncology patients participate in clinical trial (8). In

another study of Harris Interactive Survey a staggering 71% of eligible subjects choose

not to participate in a clinical trial (9).

In a randomized clinical trial recruiting a patient has become one of the most major

barriers that may decide the fate of a new molecules or generic drugs. Various studies

identified some of the main barriers of patient recruitment such as race, personal reasons,

language problem, patient preferences, education, age, eligibility criteria and other factors

(11-27). Similarly numerous studies also suggested adequate measures that need to be
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considered during patient recruitment process (28-34). Several organizations often face

financial problems and limited resources while addressing measures to overcome

recruitment barriers. The comprehensive list of recruitment barriers also makes it

impossible to generalize the individual differences such as lifestyle divergence, cultural

and religious differences, social and economic conditions. In a global clinical trial it is

important to consider the differences in social and cultural issues, as it is important to

focus on specific effective measures to minimize those barriers wherever the patients are

available.

2.2.4.1 Indian scenario

It was until recently that clinical research is evolving dramatically in India with the

constant increase in outsourcing by foreign pharmaceutical companies. However the

awareness of clinical trial among Indian people is very low as compared to European

countries and US. Prior to participating in a clinical trial 56% of Indian population are not

aware of clinical research and an overwhelming 97% of patients first came to know about

clinical trial through physician as compared to 23% in the US. The understanding of the

study in a clinical trial among Indian people is another major concern, since only 8% of

patients were able to make their decision to participate in a clinical trial as compared to

38% in the US.

In spite of all the issues of awareness among the Indian population clinical trials are

being conducted at a fast rate. The reason could be due to the amendment of Schedule Y

of the Drugs and Cosmetics Act of India which are upgraded as equivalent to the section

of USFDA to harmonize with the ICH standard. Since the regulatory barriers are being
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removed to perform clinical trials and identifying the potential to enroll patient at much

faster rate, more pharmaceutical companies and CRO’s have now identified India as a

global hub for clinical research industry.

2.2.4.1.1 Advantages of conducting clinical trials in India

Today India possesses several unique criteria for becoming a preferred destination of

global clinical trials.

western disease
distribution
diverse cultural
and socio-
economic availability of high
background patient pool

high patient:doctor treatment naive

ratio India patient
advantage

no language low cost

barriers

highly qualified
world class hospitals proffessionals
and CR facilities

Figure 2: Advantages of conducting clinical trials in India

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2.2.4.1.2 Factors affecting patient recruitment in India

A written informed consent is usually given prior to participation in a clinical trial to

respect the integrity of the subject. In a country such as India illiteracy could lead patient

to participate in a clinical trial by applying pressure by the sponsors to enhance their

research without considering the ethical criteria. Factors such as geographical region,

culture, socio-economic background and other market related environment offer India the

potential to recruit large number of subjects even without advertisement or enrollment

campaign. Majority of the population in India are not supported by healthcare system

besides the private medicine support is very costly which is beyond the financial reach to

majority of the Indian population. As a result many people still rely on government run

health care support. It is through this hospitals and other health care support that refer

patients to enter clinical trial in major cities and towns. Some of the popular hospitals

with subsidized nature in India like AIIMS (All India Institute of Medical Science,

Delhi), CMC (Christian Medical College, Vellore) and TATA (Tata Memorial Hospitals,

Mumbai) attract a lot of patient from different parts of the country because of the

infrastructure, facilities and presence of ethics committee. These hospitals have a large

number of patient database of varying patient profile and has become the referral center

for enrolling patient in a clinical trial. At present more than 80 private and government

hospitals in India are engaged in international clinical trials. India now has conducted

more than 100 clinical trials involving around 15,000 patients.

It is imminent that the socio-economic factors have contributed in recruiting patient in

India due to poverty, illiteracy and other social ills. It is acknowledgeable that in India the

potential participants maybe either poor or illiterate and might not be able to decide on
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their own to participate. The complicated nature of the clinical trial such statistical design

and procedure further adds up to their inability to understand the nature of the trial. Such

factors may contribute them to participate through socioeconomic compulsion regardless

of the risk and danger they may encounter. Moreover, in a country such as India where

huge numbers of population are illiterate the study subject could be easily coerced by the

researchers compromising the guideline adherence. Another compelling factor of patient

participation in clinical trial could be impoverishment. Almost all impoverish person in

India rely on government institution for their health. These people main factors for

participating in a trial could be to reduce their economic burden and gaining access to

free medication and treatment along with getting incentives and other benefits.

With the exclusion of few states in South India, majority of the people in India speaks

Hindi, while English has become as a common language for all official purpose.

However the fact is most of the people in India are illiterate and majority of them are

confine with their own local knowledge. This could be one of the major barriers for the

sponsor in patient recruitment. In an Indian context the most important element to enroll

patient could be overcome by giving a proper counseling and guidance by the

investigators. The sponsors in return are quick to response to this issue and are allowing

investigators to recruit patient for them by providing them with incentives and extra

benefits. Another cultural barrier in India is the family barrier where for instance if a

female is to participate in a trial she enters the trial only after consultation with either

husband or parents or other family members. Other factors such as feeling offended while

undergoing the procedure of the protocol (example getting pregnancy test, HIV test etc)

could play a significant role in their participation. Regardless of all those barriers one of
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the main factors for participation could be due to deep respect towards physician. In other

way this cultural value of respect for physician in India has contributed to fast

recruitment rate. The cultural factors however have also imparted responsibilities towards

the physician to safeguard patient more carefully and appropriately.

2.2.4.1.3 Rationality of the study

In contrast with the western countries, most of the patient participants are treatment naïve

indicating the socio-economic factors and quality of life of those patients that may

possibly contribute them to enter a clinical trial. A study conducted by CRO Excel Life

Science showed that an overwhelming 97% of patients in India enter clinical trial because

of the advice or referral by their primary care physician (10). It is apparent that the

patients are either influence by their doctor’s advice or unwilling to deviate from the

doctor’s judgment. This may bring about conflict of interest particularly when the doctors

are paid for recruitment fees to recruit patients in the trials. Several studies have shown

that very few patients participate in a trial to receive money who might possibly have

overlooked the risk involve in participation.

ICMR guidelines clearly state that, payments to participant should not be so large or the

medical services provided to the study subject should not be so extensive so that the most

important factor a patient should enter a trial is through his/her willingness to participate

with a proper knowledge on all aspects of the trial.

In a culturally diverse country such as India it becomes a problematic since it is at the

epicenter of a global clinical trial. The growing R & D capabilities, enormous

professionals, improve infrastructure and large patient pool made India global site for
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health research. One of the major reason India has become a suitable location for global

clinical trial is due to its enormous potential to enroll patients in a short time (35, 36) with

as much as ten times faster in enrolment rates than US (37, 38). Other factors like

heterogeneous population and variety of disease with incidence rates almost equivalent to

other developed and developing countries have also contributed to the advantage of India

as a global site for conducting clinical trial (39). However, more often the ethical criteria

are being overlooked as being shown in the enormous enrolment rate and other studies.

The economic status, illiteracy and cultural barriers make those populations vulnerable

not entirely knowing the outcome of the research.

At present only a limited number of studies have been conducted regarding the specific

contributing factors on patient recruitment in India. It would therefore be unreliable and

inconclusive to include those studies in the decision making process by the

pharmaceutical companies, CRO’s and other decision makers. This study will focus on

addressing the main contributing factors and roadblocks of patient enrollment within the

Indian population by designing a meta-analysis to determine the key issues. Highlighting

those factors will enable researchers to refocus and rethink their strategies with precision.
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3. AIMS

To evaluate the factors affecting participation of Indian subjects in clinical trial

4. OBJECTIVES:

1. To identify factors that favours patient participation in clinical trial in India.

2. To identify barriers of patient participation in clinical trial in India.

3. To key out strategies for improving patient participation in clinical trial in India.
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5. RESEARCH METHODOLOGY

5.1.Defining a Research Question:

The main objective for conducting this study is to identify the contributing factors of

patient participation in clinical trial within the Indian population. This study will evaluate

both the contributing factors and barriers of patient recruitment by utilizing meta-

analysis. Various experimental and qualitative studies relating to clinical trial conducted

from 1986-2008 will be included for the purpose of this study.

5.2.Ethical Approval:

Since the study will evaluate only published literature, ethical approval was not applied.

5.3.Selection of studies:

A comprehensive and systematic search for literature was performed from the following

online database.

 Pubmed

 PLOS Hub

 Opengate

 Cochrane

 Medind

 BMJ

 Medknow

 Springer

 The Indian Journal of Medical Research

 Indian Journal of Medical Science

The searched literature from these online databases was from 1900-2008.
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5.4 Following keywords were used as a search strategy

 Patient participation in clinical trial in India

 Patient participation

 Survey on subject participant

 Patient enrolment strategy

 Barriers in patient enrolment

 Factors affecting patient enrolment in India

 Subject participation in HIV clinical trial

 Subject participation in cancer clinical trial

For a more comprehensive search the references from the retrieved articles were also read

for relevant articles.

5.5. Inclusion/Exclusion Criteria

The reviewer independently evaluated all the retrieved articles for inclusion and

exclusion criteria based on the objectives of the study that will answer the research

question.

Inclusion Criteria Exclusion Criteria

Studies or surveys confined to Indian Studies or surveys that include non-

Indians

Full text articles Articles that are not published

Experimental or Qualitative studies on Studies that are not related to clinical

clinical trial trial

Studies that include the factors affecting

patient participation in India

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A total of 323 studies were identified for the purpose of this study. While going

through the abstracts 213 articles were excluded due to the following reasons:

 No Indian population

 Undesired outcomes

 Studies not related to clinical trial

A further 103 were excluded due to the following reasons:

 No Indian population

 Non-availability of full text articles

 Non research articles such as editorial, reports, news, opinions, and reviews

In the end, 7 articles were eligible as per the inclusion criteria and were involved in

the final analysis. The reviewer made one exception to the inclusion criteria by

including one study which was not published but the study survey data was presented

in one of the conferences and since the data was authentic it was justified to be

included in the final analysis.

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Figure 3: QUOROM statement flow diagram:

Relevant articles identified on the basis of the title (n=323)

Total abstracts excluded (n=213)

No Indian population, undesired outcome,

study not related to clinical trial.

After screening the abstracts (n=110)

Excluded articles after further screening

(n=103)

No full text, no Indian population, not a

research articles, undesired outcome.

Articles included for final analysis (n=7)

5.6. Study Characteristics:

Descriptive data was collected from each study to be included in the meta-analysis. The

characteristic included in the study are demographic details of the study participants like

ethnicity, age, study outcome and country where the study was conducted.

5.7. Interpretation

The included study will be analysed by utilizing met-analysis. Two tables - 1.factors

favouring participation and 2.barriers to participation will be interpreted. The two tables contain

six themes each where a percentage will be calculated to determine which specific factors require

more attention.
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6. RESULT

All the data’s included in the meta-analysis were entirely reported from the Indian

population. Nevertheless two of the studies included were conducted in US and European

countries where Indian populations have participated while the remaining five studies

were conducted in India itself. Altogether seven studies were included in the final

analysis after considering all the inclusion and exclusion criteria. The studies taken from

the US and European countries had a mixed ethnic population. Out of the seven studies,

three were focused on participation in HIV vaccine trial while the remaining four were

study subjects that are already participating in clinical trials. Two studies had the same

author and respondent’s demography but the title and methodology were different; one

study was solely focus on structured questionnaire while the other study was about focus

group discussion. The minimum age participated among the seven studies was 15 years

of age. However, three studies did not mention the age group of the participants. Overall

numbers of Indian participants out of the seven studies are 1398. The intervention used

among the seven studies includes survey with structured and semi-structured

questionnaire, focus group discussion and online interview. All the data’s from the seven

studies are presented in the form of percentage which are shown in table 2 and 3

respectively. Apart from the tables, the reviewer also analyses the result by using quotes

from the respondents for better interpretation. After thoroughly reviewing all the data’s

from the included studies twelve specific themes were shortlisted for the final analysis.

Table2 represents the factors that favor patient participation while table3 represents the

barriers of patient participation in a clinical trial.

The overview of characteristics of the study is shown in table1:

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Table1. Characteristic of the study:

Title of the study Study Age Location Purpose of the study
population group of the
study
A pilot study on 112 (all Above 15 India 1. Willingness to
willingness to Indians) participate in a future
participate in future -67 (male) HIV vaccine trial
preventive HIV -45 (female) 2. Factors that enhance or
vaccine trials deter these individuals
from participating in a
future HIV vaccine trial
3. Potential impact of HIV
vaccine trial
participation on risky
drug and sexual
behavior among these
persons.
Correlates of HIV 349 (all Not India 1. To explore the level of
vaccine trial Indians) mentioned concerns and
participation: an -205 (male) preparedness for HIV
Indian perspective -144 vaccine trials among the
(female) persons with low and
high risk for HIV
infection
Involving South 100 (20 18 years UK 1. Identify how South East
Asian patients in Indians) and above (Leeds Asian conceptualize and
clinical trials and understand the notion of
Bradford clinical trial
area) 2. Identify the key process
which impact on
decision-making to
participate in a clinical
trial.
Participation in 2935 (128 18 years US
Clinical Trials Lower Indians) and above 1. Opportunities and
in Europe and India participation in clinical
than in the United trials
States 2. Reasons for
participation and
likelihood of future
participation
3. Factors Very Likely to
Influence Participation
4. Risks and Benefits of
Participating in Clinical
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Trials
Perceptions of a 112 (all Above 15 India 1. Willingness to
Community Sample Indians) participate in a future
about Participation in -67 (male) HIV vaccine trial
Future HIV Vaccine -45 (female) 2. Factors that enhance or
Trials in South India deter these individuals
from participating in a
future HIV vaccine trial
3. Potential impact of HIV
vaccine trial
participation on risky
drug and sexual
behavior among these
persons.
Recruitment of 152 (all Not India 1. To find out whether
subjects for clinical Indians) mentioned patients are willing to
trials after informed participate in a clinical
consent: does gender trial after receiving
and educational status either partial or
make a difference? complete information
regarding a trial
2. To test the depth of
understanding patient
who has consented to
participate after full
disclosure.
A survey on patient 525 (all Not India 1. To find out the patient
participation in Indians) mentioned recruitment procedure
clinical trial and inform consent
quality.
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6.1. Contributing factors that favor subject participation in a

clinical trial:

Table2. Factors favoring participation in clinical trial

Personal Benefits Social Benefits Generate Knowledge Motivating Physicians

extra associated methods
income with the for
trial participati
on
Less chance of There will be an Money If they knew Internet Learn about
getting infected affective HIV the risk (32) clinical
with HIV vaccine in a few associated research
years with study from
treatment regular
physician
Protection from Vaccines will Insurance If they knew Email Trust in
HIV reduce the threat the drug notification government
of HIV infection could cure (37) doctors for
them safety
Importance of HIV will become Earn extra Understand Physicians Doctors
HIV vaccine for preventable like money the (97) only do
self polio HIV/AIDS good
vaccine trial
concepts
Better treatment Willingness is Receive Belief in The Out of
important for the money for success of governmen obligation to
common good of participatio AIDS t agencies doctor
India n vaccine or the
governmen
t television
news
channel
Looking for cure Help researchers Harris
prevent HIV/AIDS interactive
Better treatment Even if the vaccine Awareness
does not work, of the HIV
help researchers Vaccine
find an effective campaign
vaccine in India
Looking for Altruism Traditional
observed benefit media (eg.
Newspaper
 31

s,
magazines,
TV, radio)
Higher quality Advanced
care medicine and
science
Free medication Help others with
and medical care the condition
Relief of pain Help advance
scientific
knowledge
If related to own Help medical
health community
To help the society
To increase
scientific
knowledge
37% 57% 30% 54% 32% 47%

6.1.1. Personal Benefits 37%

The number of studies contributing to this theme included all the seven studies.

Respondents tend to be more willing to participate if they are convinced that the trial

would personally benefit them associated with the condition (43). People think that if the

treatment are free and provide better treatment or may cure the terminal disease, they

would most likely choose to participate in the trial with the hope of improving the disease

or to cure them (43). Respondents felt that they would benefit from powerful vaccine by

involving in a trial and would completely protect them from HIV infection after the

completion of the trial. “Initially it (the HIV vaccine) will give 75% protection. At the

end of the research, it will be 100%, hence there is no harm” (44). In one study,

participants ascertained that all women should be vaccinated with HIV vaccine along

with drivers and sweepers, children, own risk behavior sex workers and couples. In terms

of personal benefits the percentage of respondents showed much higher for those who
 32

were looking for prevention than those who were looking for better treatment or higher

quality care or free medication.

6.1.2. Social Benefits 57%

All the seven studies contributed to this theme. Contributing for the common cause of the

society as well as enhancing the progress of the scientific and medical knowledge

inspired many respondents to participate in a clinical trial. A sense of responsibility

towards the humanity is among one of the compelling reasons a person participate in

clinical trial. Majority of the respondents were looking forward to be a part of the

research study for the betterment of mankind. “… Everyone has a responsibility to

participate in such matters, our community is not aware, we should bring them in level

with the rest, inform the” (42). Respondents also believe that holding responsibility for

others allows them to consider whether or not to participate in a trial. “Because we’re

here to help each other, that’s the main thing” (42). The finding in this theme is that, the

percentage of respondents to participate in a trial were almost double in cases for

preventive trial such as HIV vaccine trial in contrast with those trial the will enhance

science and medicine.

6.1.3. Generate extra income 30%

Four of the seven studies fitted into this theme. Respondents indicated that their

participation was influence by the offer of money as a means of incentives (41). One of

the respondents stated, “…. We want a written guarantee plus insurance policy. The

document should specify that, in the event of death (of the person after taking the

vaccine), his family would be given full support” (44). It is apparent that the participants
 33

were seeking for monetary compensation to be included in the inform consent in the case

of events like serious adverse effect or adverse reaction that may lead to dead.

6.1.4. Knowledge associated with the trial 54%

Three out of the seven studies contributed to this theme. Informing the potential risk that

may occur during the trial and being well informed about the procedure could tender

potential participants to participate in the clinical trial. Respondents agree that the manner

in which the trial staff provides information can give them the confidence to participate.

In one of the HIV vaccine trial respondents were willing to participate if they are given

assurance that the experimental vaccine trial would be safe and effective to conduct on

human.

6.1.5. Motivating Methods for Participation 32%:

Three out of the seven studies contributed to this theme. Respondents were more willing

to participate if the clinical trial information was provided by the government owned

television channel. Similarly some respondents also preferred newspaper and healthcare

providers regarding the information about clinical trials. Education was also a factor that

could persuade people participate in a clinical trial. Other potential motivating factors

that could contribute to participation in a clinical trial include TV, radio, magazines,

newspapers, internet, Harris Interactive, advocacy group and family/friends. The success

story of polio vaccination conducted by the government has also made respondents

confident that HIV vaccine would similarly have a great impact on the society.
 34

6.1.6. Physicians 47%

Five out of the seven studies contributed to this theme. Most studies cited that their

family physician/general practitioners held a high esteem and considered participating in

a trial if they are encourage doing so. “I have been taught this is a noble profession. And

the ethics of the profession of converse, as you know, converse life, and I would never

even dream of suspecting a doctor, I wouldn’t” (42).

6.2. Barriers to participate in clinical trials

Table3. Barriers to participation in clinical trials

Logistical Concern about Fear Confidentiality Psychosocial Mistrust

problem and the treatment issues factors towards
misconception trial
sponsors
Uncertainties Not willing Unknown long- Effect on Couple Are like
unless I knew I term side effects- insurance, disharmony guinea
was getting the uncomfortable marriage or pigs
vaccine getting a job
Effect on travel Comfortable if I Fear of injection Lack of privacy Social Worry about
knew the vaccine at home support mode of
is powerful treatment i.e.
enough whether
given
vaccine or
placebo
Time constraint Comfortable if I Long-term effect Privacy Peer family Are taking a
knew how it of vaccine concerns pressure gamble with
would affect my their health
life
Not able to make Do not want to Concern about Difficult to Do not want
independent interrupt safety procedure decide in to take drugs
decision treatment anticipation without
treating
doctors
permission
Lack of Did not want to Side effects Lack of
knowledge take new drugs empowermen
 35

t: issue of
male
involvement.
Did not Afraid of test Lack of
understand supportive
network/fami
ly
commitments
Busy lifestyles Too much blood
already
withdrawn
Language Concern about
drug side-effects
Migrant workers
Cultural issue
pertaining to
gender
Asymptomatic/no
disease
Stigma
18% 33% 19% 16% 11% 24%

6.2.1. Logistical problem and misconception 18%

Five out of seven studies contributed to this theme. This theme emphasized on the

difficulties and challenges for participating in a clinical trial. Some of the difficulties

participants often face is travelling long distance, busy lifestyle, and understanding

inform consent and other logistical problem. Respondents were also afraid that they will

be stigmatized for participating in a trial even if they do not have the disease.

6.2.2. Concern about the treatment 33%

Three out of the seven studies contributed to this theme. Respondents gave different view

concerning about the treatment they will be undergoing which let to certain barriers for

them to participate, In a HIV vaccine trial participants were afraid whether they will

receive a vaccine or a placebo and therefore refused to participate. Respondents also did
 36

not want to be involved in a new treatment because it would interrupt in their current

treatment, similarly some respondents simply did not want to participate because they did

not want to start new treatment. Concerns about the trial treatment were also felt on old

people and others who are on multiple drugs because of the fear of drug-drug

interactions, “Personally only because of my health, because I’m on other medication and

I think that might affect it…. It might react adversely to the drug I’m taking so many that

would be another reason why I personally wouldn’t do it” (42).

6.2.3. Fear19%

Six out of seven studies contributed to this theme. The fear of participating in a clinical

trial is clearly visible on a lot of aspects. Some people simply ignore to participate

because of the fear of injection. Respondents were more likely to voice their opinion

regarding safety and effectiveness of the trial with regards to possible side effects,

adverse reaction and safety procedure. For instance, in some of the government settings

people are afraid of the syringes and other tools that will be used during the procedure.

6.2.4. Confidentiality issue 16%

Three out of the seven studies included in this theme. Privacy remains another factor

where respondents gave as a reason for not participating in a clinical trial. Respondents

felt that it was important to safeguard the privacy or it will affect in their marriage,

employment and insurance. Potential participants in HIV vaccine trial were highly

concerned about the confidentiality of their personal information because people are

aware that HIV/AIDS is not just an ordinary disease. Similarly respondents pointed out

that there is lack of privacy at home which concerns them to enroll in a trial.
 37

6.2.5. Psychosocial factors 11%

The factors associated with regards to psychosocial issues include lack of empowerment,

social support, couple disharmony, peer family and difficult to decide in anticipation etc.

“cannot come alone”, “Do not have knowledge, will ask husband...”, “Has to see what

husband says…”, “Husband will scold…”, “Husband may have doubt”, “can come if a

friend comes” (41). It is apparent that most Indian people lack the confidence to take

decision on their own and seems to rely on family or spouse. This aspect on clinical trial

participation is no different. They have this feeling of fear towards taking an independent

decision. Even though they have given a thought of participating, they are not able to

answer whether to participate in a trial or not.

6.2.6 Mistrust towards trial sponsors 24%

Four out of the seven studies contributed to this theme. Respondents felt that they would

be treated as guinea pigs after making personal inferences about the trial. They also

feared of receiving placebo which would not benefit their health at all and therefore

indicated their mistrust towards the organization on how the trial would be conducted. It

was also apparent that the patient would refer to their family doctors to give them advice

relating to participation in the trial, thus showing their mistrust towards the organization.
 38

7. DISCUSISION
The systematic review was performed by retrieving, selecting and analyzing the qualitative dates

of the studies to evaluate the factors that contribute to the factors affecting clinical trial

participation among the Indian subjects. The purpose of conducting systematic review is

important because evaluating Indian subjects on factors associated with participation will

provide better picture of the subject’s mindset on what determines their decision to participate or

not to participate in a clinical trial. The evaluation was carried out by two broad categories where

specific themes were identified for different factors; factors that favor participation and factors

that limit participation. The themes in factors favoring participation include personal benefits,

social benefits; generate extra income, knowledge associated with the trial, motivating methods

for participation and physicians. While the themes included in factors restricting participation are

logistical problems and misconception, concern about the treatment, confidentiality issue,

psychosocial factors and mistrust towards the sponsors. The contributing factors were allocated

on specific themes wherever it is associated and a percentage was calculated for each theme. The

purpose of calculating the percentage is to highlight which theme needs more attention for any

rectification either to encourage participation or eliminate barriers.

The study was primarily focused on Indian population because of the following reasons: 1. India

has become one of the hotspot for conducting global trials. 2. The availability of huge and

diverse population is favorable for implementing clinical trials because it enhances the rate of

enrollment. 3. Indian population (racial and ethnic group) has a unique ways of interpreting and

making a decision to participate in a clinical trial. Therefore it is important to understand the

factors the influences their decision to participate in a clinical trial.

 39

The result shows that Indian people were more willing (prevalence-37%) to participate in a

clinical trial if they are provided with healthcare benefits. In almost all the major ethnic group it

has been confirms that personal benefits influences people to participate in a clinical trial (47).

Participants who were involved in HIV vaccine trial thought that, they will be protected from

HIV infection by participating in the trial. They believed that HIV is preventable by taking HIV

vaccine similar to polio vaccine (40). Personal benefit can take various forms such as free

medication, high quality care, better treatment, possible protection through vaccine trial and

possible cure by trial intervention. Personal benefits for relatives or family members are also

valued while considering participation in a trial. “…if it makes their life better and she’s going to

make the Chapatis again the yes they’ll sign it (consent form) (42). Some participants also felt

that the disparity between the couples could also be due to their desire to protect itself from the

fear of infection. “We may be unaware of the behavior of the men folk. If they had gone astray,

there are chances of us also to get infected. By taking the vaccine, this can be prevented” (44). In

a similar way, participating in the HIV Vaccine trial would benefit personally as well as to their

spouse. A strong affection towards the family members also contributes in participating in a

clinical trial provided the research would benefit them, “My son was born with a hole in his

heart and were constantly in and out for the first year and the hospital asked me if I could put my

child forward for the student’s exams and assessments” (42). By benefitting his family, he

benefits himself from the trial because he has executed his strong sense of responsibility. One

male respondent with H. pylori was very much willing to participate if the trial could cure his

indigestion. “Well they asked me and I said, ‘why not? Go for it’, because the main reason was I

used to have indigestion, and I wanted to find out why do I have indigestion…so I thought if it’ll

cure, if they can find out why not have a go and have a trial, that was the main reason” (42).
 40

Earlier studies showed that people participate in clinical trial for personal benefits due to the

non-availability of medicine (42, 48). However it has broader issues now such as cultural factors,

socio-economic factors and healthcare conditions that are predominant in the country. For

example, people from lower economic background are attracted and influence to participate in a

clinical trial by the offering of free medical treatment and other benefits.

On the other hand 57% of the respondents were willing to participate for the common cause of

social welfare and to advance science and medicine. This shows that not only they want to get

cured but they also want others to get cured, thus showing goodwill for the society and science.

In one study, an overwhelming 98% of the participants agreed that participating in a HIV

Vaccine Trial will benefit for the common good of India (40). People also participate in clinical

trial for the advancement of medicine and science. Respondents also felt a sense of pride in

themselves indicating their desire to contribute for the society. “I fell glad to take social risk”,

“Do something that is good for the world” (41). Respondents from HIV Vaccine trial stress that

participating in such trial would benefit the society and stop HIV infection. “Helping to find a

vaccine that works”, “helping to stop the epidemic” (40). However respondents were also

optimistic that their participation would directly impact the current scenario. Nevertheless they

were more willing to participate for their children and the future generation. “We should not

think that something does not benefit us now and why should we participate, humans should not

think like this if it has not benefited my generation but the third generation it may benefit them,

then I should take a part” (42). The evidence of altruistic motivation can also be seen when

healthy volunteers participate in clinical trial. However, in contrast to other respondents,

 41

respondents from HIV vaccine trial had more intend, almost triple the percentage to participate

as a selfless wish to benefit the society (41-46).

The result also shows that Indian people rely on physician (37%) while taking decision to

participate in a clinical trial. The physicians are considered as health guide among the Indian

population and people hold them high esteem believing that they will never misguide them.

Therefore if a physician tells or advice them to participate in a clinical trial, it is highly unlikely

to refuse them. It is apparent that the doctors have a great impact on the decision-making process

in the Indian culture. They think that doctors will only do good and will be responsible to

safeguard the health of a patient. Various studies have pointed out the roles of physician in

patient recruitment through recommendation, encouragement and other means of communication

(48-52). There is a well known fact that the relationship between a doctor and a physician is

unequal and the patients tend to go by the doctors judgment. They fear that refusal to participate

in a trial as referred by their physician would affect them to gain access to medical care.

Generating extra income also remains a significant theme in this study where patient’s health is

put to unnecessary risk for the sake of monetary gain. In a country such as India where poverty is

apparent it is highly likely that money could be an influence to their participation. It is important

to understand their judgment on the likes of monetary and other incentives influencing in their

participation.

This systematic review also showed that understanding the detailed knowledge about the trial

such as objectives and procedures enhances the chances of subject participation. Education is one
 42

of the issue that many people raised in the HIV vaccine trial as cited by one of the respondents

“community members would want to know about the frequency of the vaccine and the site

administered, how it might impact marriage, how long the HIV positive result will last, how long

will the vaccine protected for, and will the vaccine be effective” (44). In one study, majority of

the participants understood that the research study is voluntary and they were also aware of the

risk involved in the study (43). It was also apparent, that respondents showed greater willingness

to participate by understanding the use of the vaccine and efforts that are being made for vaccine

development. “The ELIZA test will be positive due to vaccination. We should tell those persons

who had taken the vaccines that the positivity would disappear after some time” and “If we go

separately to the doctors and get tested, there will not be any problems. When the husband and

wife go together, there will be a problem due to the positive result” (44). The respondents wanted

to understand the concept of HIV vaccine trial like duration of protection, site of administration

and effectiveness of the HIV vaccine trial. Most of the participants felt that the terminologist

were major concern to understand the concept of the trial and preferred simple information. “I

understand bits of it, some things I didn’t understand. The second time I went I took my daughter

with me. She explained what he said and that they will offer to get somebody to translate for me.

When I visit the doctor I occasionally take my daughter because of the terminology used” (42).

This indicates that languages, trial staff attitude and terminology could all play an important role

in enrolling the potential participants. If there is any misconception about the trial the potential

participants are made proper understanding through constant verbal explanation. In any case,

lack of knowledge about the trial could lead to possible non-participation. At the same time

providing incomplete information or hiding information would be violating the ethical conduct

of the clinical trial.

 43

Moreover, motivating factors like TV, advertisement, newspaper, radio, awareness campaign

also enhances the rate of recruitment by educating and clarifying any misconception that may

prevail among the people. Participants felt that the government will never do wrong and wants

the government to handle HIV vaccine trial. “If it is done through the government, many people

could come forward to take it”. “…the government is never wrong. Therefore, if the government

endorses a vaccine, it will surely be safe. So we can take the vaccine without fear” (44). The

respondents also suggested that the researchers should informed the future HIV vaccine trial as

quoted by one of the respondents “being HIV positive is a part of the vaccine trial and be so

declared, if necessary” (44). Potential participants consider the importance of healthcare camps

that are emphasized on trial-related information. “We have a good community spirit at the

Mandir and sometimes they organize specialists to come in so we can talk about our health

problems. If they talk about clinical trials and medical research I think many people would take

an interest and be willing to participate” (42). To sum up, factors such as personal benefits,

altruism and monetary could play a role in the decision making process of the individual while

themes like physician and knowledge of the trial indicates that physician do play a major role in

recruitment. Therefore it is extremely important that physician involving in recruitment plan

should be properly trained and possesses all the required knowledge about the trial.

Although respondents indicated their trust towards physicians, distrust towards researchers and

physicians were also expressed as one of the barriers (24%) by the respondents. Factors such as

fear of receiving placebo, the idea of treating as guinea pigs, distrust in clinical research have

shown as a negative impact towards the subjects thus indicating as barriers to their participation.
 44

The differences in trust and mistrust by the respondents towards the physician and researchers

could be due to previous experiences in clinical trial, literacy and ethnic variation (53, 54). It is

therefore important to promote trust and identify the source of mistrust within the trial

organization to enhance trust among the potential subjects.

Respondents also indicated fear such as side-effects, afraid of test and injection, safety and

efficacy issue as major barriers for them to participate in a trial. In a HIV vaccine trial

respondents fear that they might be infected with HIV while participating in the trial. “Feel fear

of getting other disease…”. “I might get AIDS” (41). Respondents were not willing to

participate unless they are guaranteed that participating in the trial would not lead to long-term

side effect. “…But guarantee that there’s going to be no harm to yourselves or whatever, you

know, there’s not going to be any reaction…. That’s why you are researching, so you are using

them as a form of guinea pig to be honest. You know, so there will be reaction and I wouldn’t be

impressed with that” (42).

Subjects participating in a clinical trial involve a lot of commitment to ensure that they follow

the procedure as per the protocol. However, the daily routine of life could impact their daily

routine of lifestyle which in some cases might be unavoidable and could jeopardize their

involvement in the trial even if they are willing to participate. “Because of time I cannot enroll”.

“Have work ... will go to Nepal” (41). For instance there could be travelling burden, busy

lifestyle, time constraint etc (41, 40). Lack of knowledge about the trial is also a factor in which

many participants opt out to participate. Some respondents lack decision making fearing that the

studies could not be decided on what will happen to their future. In one of the study that was
 45

conducted in the UK, the South Asian participants felt that the inability to speak English was a

major barrier to participate in a trial.”...because of the language barrier and because the majority

of South Asian people that I see are women, I feel sometimes that there is little bit of a barrier”

(42). The complicated nature of filling up the inform consent makes the potential participants

difficult to decide. “… I think sometimes the official form is a bit threatening to people, they

think because they got this written form they’ve got to sign…. And sometimes I think that makes

people nervous, because they think, ‘God this must be something really big if I’ve to do this. I

get asked about all sort of things and I don’t have to do this’… and that’s sometimes a bit scary

for people, I think” (42). In Indian culture people believe that male are more dominant and

women often find it hard to make a decision of their own which was regarded as one of the

frequent barriers among women to participate in a trial. “Husband should be given first” (41).

Misconception needs to be assessed by educating the potential participants in a way that will

make them understand completely so that they take a proper decision accordingly. Trial burden

such as busy lifestyle and travelling burden also adds to their barriers. Reducing this entire

burden would make trial participation in India a lot easier and faster.

In addition to this, confidentiality issue also contributes to the barrier in participation which is

considered as an important concern. The subjects seek for integrity at any costs and therefore

their privacy must be acknowledge and considered. A number of respondents also shared their

concern about the involvement of family, spouse and peers while making a decision to

participate. It is Indian culture to discuss health related issues with their family and peers

contradicting the US cultures where the doctors never discloses health issues with family or

friends other than the patient itself. In India cultural barrier is a common phenomenon which
 46

needs proper attention for rectification. Language has also been identified as common barriers

among South Asian particularly Indians living in the UK and US. Several measures were used to

overcome language hurdles by introducing translators. However due to the lack of technical

terms and complicated nature of clinical trial concept it adds further burden to solve such forms

of barriers. The only way to introduce translators is to train the translators about clinical trial

concept.

The overall study was not very satisfactory because the reviewer could not include some

important elements such as population-based surveys and other external validity which would

have evaluated more dimensions regarding the contributing factors of trial participation. The

respondent’s age group was not mention in three studies while four studies did not mention the

ma/female ratio. This could have an impact on determining the specific demography that needs

to be evaluated. Statistical heterogeneity was also observed across the themes. This led to weaker

inferences about the estimates of overall effect. There was inconsistency among the study results

which made it difficult to interpret the results of the systematic review. Two of the studies with

focus group discussion did not provide data’s to be included in the statistical analysis which

limited the strength of the conclusions. Since it was an individual thesis, independent data

reviewer was not available which limited the reviewer in assessing the validity of the included

studies.

In some cases, relevant articles which the reviewer thought might be eligible to be included for

the final analysis could not be either access or full text not available. One study included in the

final analysis was unpublished studies. The result of the survey was presented in one of the
 47

conference held in ICRI, Mumbai. However, the inclusion of this data was not influence by any

source of bias rather the reviewer considered the data authentic for final analysis and would be

justifiable as an exception to the inclusion criteria. In a diverse country such as India with a

variety of cultural heritages, religious beliefs and ethnicities the result may vary with different

groups of people.
 48

8. CONCLUSION
This systematic review solely focuses on subject participation in clinical trial within the

Indian population by evaluating the factors that either favors or hinders participation.

India has a great potential for and prospects for future clinical trial and it is essential to

take appropriate measures for future planning. It is important that research studies heeds

to be conducted to understand the clear mindset of the people from different ethnic

groups and cultural backgrounds. Researchers should employ more multi-recruitment

strategies in their approach. The demographic and social profile of the Indian population

should be defined for better implementation. Educating patient through various means

such as awareness campaign and effective media will help to enable and promote trust

towards people and enhance large better enrollment frequency. It is evident from the past

study that informed consent was not exercise appropriately and therefore needs to be

improved. More emphasis should be given to the potential participants on medical

attention rather than personal benefits. In order to assure subjects safety and confidence it

is also important to assure them about the presence of data safety and monitoring board.

This will further help in establishing trust with the participants. Assurance of keeping

confidentiality is also necessary from the perspective of study subjects and needs to be

respected. India possesses tremendous doctors and researchers who need to be trained

properly about all the necessary knowledge of clinical trial so that all the participants are

enrolled ethically.

The government should involve more in its participation and set up a proper structure to

regulate the conduct of clinical trial before promoting India as a global clinical trial sites.
 49

Potential trial participants are very vulnerable to entering clinical trial with the lure of

obtaining healthcare or generating extra monetary possibly overlooking the risk involve

in their participation. India at present needs urgent action to counter enrolling participants

unethically so that the rights and integrity of the subjects are protected.
 50

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