Clinical trials…

From an idea into reality!

VALENTINA ERMITA HERDANI, MSC., S.FARM., APT.
VALENTINA ERMITA
HERDANI
✓Graduated as Master of Science of Clinical Trials from the University
College London (UCL) in 2017. Final project: “Trial conduct in Indonesia:
Identifying gaps in training provision in hospital settings and recommend
solutions to reflect international practice.”

✓Graduated as Certified Pharmacist from Pharmacy Department, Faculty

of Pharmacy, Sanata Dharma University in 2012

✓Graduated as Bachelor of Pharmacy from Pharmacy Department, Faculty

of Pharmacy, Sanata Dharma University in 2011

✓Working as Clinical Research Associate (CRA) in PT. Prodia DiaCRO

Laboratories with 10 trials in field of cardiovascular and heart disease,
breast cancer, neuropathy, infection (malaria, TB, typhoid fever), anaemia
and nutritional studies.
Rules
1. Bio-break is allowed anytime
2. Phone in silent mode
3. Pay attention, otherwise you will get lost
4. Please interrupt me if I speak too fast or unclear
5. Questions to be pull at the end of this session
Terminology
RCT: Randomised Controlled Trial
EC: Ethics Committee
BPOM: Badan Pengawasan Obat dan Makanan
FSR: Final study report
ICF: Informed Consent Form
CRF: Case Report Form
AE/SAE: Adverse Events/Serious Adverse Events
 What is
clinical
trial?

Content

Running
of
clinical
trial
QUIZZ!!!
1. What is clinical trials?
2. What is the main guideline used worldwide in clinical trials?
3. What are the 4 big steps in conducting clinical trials?
4. What are the stakeholders involved in the clinical trials?
5. What are documents involved in the clinical trials?
What is clinical trial?
• Any investigation in human subjects intended to
discover or verify the clinical, pharmacological
and/or other pharmacodynamic effects of an
investigational product(s), and/or to identify any
adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism,
and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.
The terms clinical trial and clinical study are
synonymous.
• Good clinical trial conduct requires the
implementation of GCP guidelines.
• Good Clinical Practice (GCP) is an international
ethical and scientific guideline for conducting clinical
trials to ensure the protection of the human
participants and data.
Why?

http://www.researchamerica.org/advocacy-action/issues-researchamerica-advocates/bench-bedside-drug-
development-pipeline
Clinical trial phases
Why do we need clinical trial?
1. Patients
2. Communities
3. Academic institution
4. Government
5. Pharmaceutical company
Why do we need clinical trial? - Px
▪Contribute in science
▪To get a chance of a better treatment
▪To help the patients with the same disease in the future
Why do we need clinical trial? - Comm
▪To offer the chance of possible new medication for the community
of people who struggle with the disease (the quality of life (QoL) and
survival rate of the patient.
▪To support the development of new drug – patient care
▪To support the science
Why do we need clinical trial? - Acad
▪To support the development of new drug and science
▪To provide the best possible healthcare option for those who suffer
by asking them to join the trial (following up to completion of trial)
▪To provide innovations that could increase the effectiveness and
efficiency of the drug, as well as the adherence of the patients
during the course of medication
▪Financial gain
Why do we need clinical trial? - Gov
▪To support the improvement of quality of life and life expectancy of
the society by allowing the conduct of clinical trials
▪To increase the medication options to help improve the health of
the society
▪Indonesia: capacity building in clinical trial
Why do we need clinical trial? - Pharma
▪Bring new and better medicine to patients by the needs of patients
and a strong scientific understanding of disease
▪To get a highly qualified drug and g
General overview
▪Next slides are the steps involved…
▪Order? Different trials might have to adjust a little…
▪Some trials may have more/less steps as they have different
requirements…
▪This module will concentrate on the most important steps…
Preparation of clinical trial
1. IDEAS: set study questions, design, objectives, sample size calculation
2. Check on the regulations? BPOM, GCP, local regulations etc. Rest of the
world: their regulations.
3. Risk assessment: GCP rev2.0.
4. Consultations: R&D, Regulators, Potential Sponsor, Collaborators, Third
Parties, Potential Sites (perform site and investigator selection).
5. Start to develop: protocol, ICF, CRF and other related documentation
(monitoring plan, management plan, etc).
Preparation of clinical trial
6. Secure funding
7. Develop plans, processes and systems: randomisation (if needed), trial
management and monitoring, statistical analysis, AE/SAE and deviation
reporting, supplies (IP, device, etc), documentation and data management
8. Submit the essential documents to ethics, regulatory authorities, other
related parties to obtain approval
9. Secure contracts with principal investigator, hospital/other related parties
10. Register the trial: clinicaltrials.gov
11. Prepare the study initiation and recruitment: documents finalised, sent to
site, IP delivered, meeting invitations sent
Running of clinical trial

Initiation Conduct Completion

Running of clinical trial - Initiation
1. Recruitment started: potential participants, obtain ICF from
eligible patients and wish to participate
2. Collect baseline data: variables to affect the outcome of interest
3. Randomisation performed
4. Documentation involved: ICF, CRF, sample handling (if any),
temperature log for investigational product (IP), transport
allowance form, etc.
Running of clinical trial - Conduct
1. Follow up all treatment groups while assessing the outcomes as
per stated in the protocol (it can be continuously or intermittently)
2. Perform monitoring as per stated in the monitoring plan (perform
source data verification (SDV), check on compliance, follow up,
temperature log form, other related forms, etc
3. Routine phone call to participants to ensure they won’t withdraw
or disappear or cannot be contacted
4. Record if there’s any lost to follow up or point No. 3 won’t work
5. Inspection and audit from regulatory authority
Running of clinical trial - Conduct
6. Perform any interim analysis (as specified in the statistical analysis
plan previously)
7. Report on the progress to the sponsor, funders, ethics committee
regulatory authorities, and other collaborators)
8. Perform revisions/document changes if necessary (inform the
whole team and ethics committee)
9. End of trial declaration after done checking all the documents. All
the queries must be closed and no more debt on documentations
Running of clinical trial – Completion
1. Analysis performed (intention-to-treat analysis or per-protocol,
depends on what stated in the SAP)
2. Interpretation (assessment on the strength of the effect and
consideration on the alternatives are explained)
3. Report the end of the trial using the final study report to the
ethics committee, regulatory authorities
4. Communicate the result: publications, seminars, panel
discussions, etc
5. Archiving
 Play with clinical trial activities
1 2 3
Create 4 groups: 1. Read the study from Discuss in group: (see
Preparation, 2. Initiation, the given journal questions below)
3. Conduct, 4. Close out (discuss)

1. What are the activities and document involved?

2. Who are the stakeholders involved?
3. How long the process will last
Conclusion
1. Clinical trials is an important steps in drug development process to
understand the efficacy and safety of the drug product
2. Good clinical practice is the main guideline to conduct clinical
trials with other local regulatory regulations (BPOM, MoH, etc)
3. There are 4 big steps in conducting clinical trials: trial preparation,
initiation, conduct and completion
4. Collaborations is the key to successfully conduct clinical trials
QUIZZ!!!
1. What is clinical trials?
2. What is the main guideline used worldwide in clinical trials?
3. What are the 4 big steps in conducting clinical trials?
4. What are the stakeholders involved in the clinical trials?
5. What are documents involved in the clinical trials?
Thank you!