Clinical trial protocol writing: Challenges and Guidelines

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CLINICAL TRIAL PROTOCOL
WRITING CHALLENGES
AND GUIDELINES
An Academic presentation by
Dr. Nancy Agens, Head, Technical Operations,
Pepgra
Group www.pepgra.com
Email pepgrahealthcare_at_gmail.com
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Today's Discussion
OUTLINE OF TOPICS
In Brief
Introduction
Challenges in Writing Clinical Protocol
General Guidelines in Writing the Clinical
Protocol Conclusion
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In Brief
The clinical study protocol is defined as the
procedures by which clinical research is
conducted. A clinical study protocol should
provide a clear clinical study design to meet the
objective of the
clinical trial. A defined protocol must address
the proposed medical question and protect the
safety and rights of the clinical
trial participant/patients.
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Introduction
Clinical trials are aimed at evaluating new
pharmaceutical drugs, medical devices,
and surgical materials.
Clinical trials are also conducted in diagnosing
diseases early to prevent the severity of the
disease conditions.
Every new finding of medical drugs and devices
goes through four phases of clinical trials to
find the appropriate dosage value and the
corresponding side effects.
Phase I The clinical trial experiments will be
carried out with a small group of
participants test the safety and side effects to
find the accurate dosage value.
Contd..
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Phase II Testing the effectiveness and obtain
preliminary data of curing rate and study the
short-term side effects.
Phase III The drug will be tested in a large
group to collect more data on safety,
effectiveness, side effects related to dosage
range with different age groups and disease
severity.
Phase IV Will be permitted to carry out with a
diverse population for a prolonged period for a
detailed study.
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Challenges in Writing Clinical Protocol
The clinical trial protocol is a well-defined
procedure of the study, and it must provide a
clear concise design to meet the objective of
the study.
The contributions of medical experts, regulatory
experts, statisticians, pharmacokineticists and
operational experts are mandatory in protocol
development.
Writing a well-communicated clinical trial
protocol is often challenging, and International
Council for Harmonisation Good Clinical Practice
provided certain recommendation like what needs
to be included in the protocol and its structure.
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General Guidelines in Writing the Clinical
Protocol 1. INTRODUCTION
The introduction must have detailed literature
review covering the existing therapeutic options
and test methods.
2. OBJECTIVE
This section should state the objective in the
form "SMART".
There are three categories they are primary,
secondary and exploratory.
Primary will deliver the aims to answer clinical
trial purpose directly.
Secondary will explain the associated actions
with the rationale.
Contd..
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Exploratory will state the hypothesis-generating
objectives that can be analysed with additional
studies.
Figure 1 Smart
Contd..
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3. POPULATION
The targeted population will be used for the
trial includes the geographical region and a
detailed list of inclusion and exclusion criteria
which specifies age, sex, BMI, etc.
4. ENDPOINTS
It is defined as an indicator in measuring a
biological sample.
There should be an endpoint which exactly matches
the objective of the study to
ensure that the correct variables are measured.
5. TRIAL DESIGN
The clinical trial design will indicate the
participant's treatment and the number of
required groups for treatment and data
collections.
Contd..
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6. CONTROL GROUPS
This section explains the control groups and the
target population should be clearly identified
and justified, and the control group must be
aligned with the clinical trial design and
objective.
7. STATISTICAL CONSIDERATIONS
This section in the protocol should explain the
rationale for the calculated sample size with the
clinical and statistical assumptions based on the
primary endpoint.
We provide statistician support, and when
applicable we offer other support, and we have
experts like pharmacodynamics experts and
clinical writing expert.
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Conclusion
The clinical protocol is the procedure by which
the trial is conducted, and the writing requires
a wide amount of assessment on all concepts
related to the trial.
Pepgra has understood the complexity of
developing a complete clinical trial protocol
with experts.
Our team of experts will thus protect the
scientific integrity of the trial and the safety
of the participants.
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EMAIL
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