This document discusses clinical trials and their various components. It begins with an introduction to clinical trials, their purpose and importance. It then describes the key elements of a clinical trial protocol including the trial design, eligibility criteria, safety measures, statistical analysis plan and informed consent process. It also discusses the role and composition of the Institutional Review Board/Independent Ethics Committee which reviews and approves clinical trial protocols and procedures. Finally, it provides an overview of the four phases of clinical trials and concludes with references.

1. CLINICALTRIAL
Presented By:
Amit Kumar Soni
First year M.Pharm(Roll No.1)
(Dept. of Pharmaceutics)
Sub: Regulatory Affair
Alard College Of Pharmacy,Pune
Under the Guidance of:
Dr. Nalanda Borkar
Head of Department
(Dept. of Pharmaceutics)
Sub: Regulatory Affair
Alard College Of Pharmacy,Pune
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2. Content
 Introduction
 Trial Protocol
 Institutional Review Board/ Independent Ethics
Committee (IRB/IEC)
 Composition of IRB/IEC
 Responsibilities of IRB/IEC
 Procedures of IRB/IEC
 Maintenance of records of IRB/IEC
 Phase of ClinicalTrials
 Reference
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3. Introduction
What is a Clinical trial?
 prospective ethically designed investigation in It human
subjects to discover/verify/compare the results of two
or more therapeutic measures (drugs)
 A clinicaI trial is a planned experiment that involves
volunteers/patients
 Aim to compare the response to new treatment with
that of an existing one
 Clinical trial is just a part of New Drug Discovery
Process.
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4. Why are clinical trials important?
 Clinical trials translate results of basic scientific research
into better ways to prevent, diagnose, or treat disease
 The more people take part, the faster we can:
o Answer critical research questions
o Find better treatments and ways to prevent disease
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5. Trial Protocol :
It is a complete written description and scientific rationale
for a research activity involving human subjects.
◦ TITLE PAGE
◦ SIGNATURE PAGE
◦ CONTENT PAGE
◦ LIST OF ABBREVIATIONS
◦ INTRODUCTION/ABSTRACT
◦ OBJECTIVES
◦ BACKGROUND/RATIONALE
◦ ELIGIBILITY CRITERIA
◦ STUDY DESIGN/METHODS (INCLUDING DRUG/DEVICE INFO)
◦ SAFETY/ADVERSE EVENTS
◦ REGULATORY GUIDANCE
◦ STATISTICAL SECTION (INCLUDING ANALYSIS AND
MONITORING)
◦ HUMAN SUBJECTS PROTECTIONIINFOR11ED CONSENT
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6. TITLE PAGE :
 Title page introduce the document ,its title, precise
number, sponsor and author to the reader.
 Protocol identifying number and date.
 The protocol number must clearly indicate the version
number, whether it is final or draft and date of this
version.
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7. Title page should includes:
 Full title should include summary study design, medicinal products
,nature of treatment (eg : treatment and diagnosis) indication
patient population setting (eg : in-patient, outpatient) Randomised
double bind multiple studies.
 Name and address of sponsor and monitor. Sponsor names and list
of responsibilities with agreed allocations
 Name and address of the authorised person to sign the protocol
and protocol amendment for the sponsor. Generally, chief
investigator for trial or principle investigator for single center
trials.
 Name ,title, address and telephone number of the sponsor medical
expert for the trial
 Name and title of the investigator who is responsible for
conducting the trial, and the address and telephone number of the
trial site.
 Name, title, address and telephone number of the qualified
physician who is responsible for all trial site related medical
decisions.
 Name and address of the clinical laboratory and other medical or
technical or institutions involved in the trial.
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8. SIGNATURE PAGE :
Signature page of all healthcare professionals in the trial
including contact details of participating site, sponsor and
sponsor medical advisor if not already given above.
CONTENT PAGE :
This help navigation through the document by large
number of different people that will be needed
throughout the trial.
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9. LIST OF ABBREVIATIONS :
All abbreviations used should be listed and defined.
Accepted international medical abbreviations should be
standardised within each project.
INTRODUCTION /
ABSTRACT :
This summary should be only one to two pages long. It
should give the reader sufficient information to
understand the rationale for the trial, its objective and the
methods that will be used to achieve these objective.
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10. OBJECTIVES :
 Objectives should be stated clearly as hypotheses to be
tested.
 Each objective should have a corresponding discussion
in the statistical section.
BACKGROUND AND
RATIONALE :
 All protocols require a section detailing the
scientific rationale for a protocol and the
justification in medical and scientific literature for
the hypothesis being proposed.
 Introductory section should be organized in a
logical, sequential flow.
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11. ELIGIBILITY CRITERIA -
DEFINITION :
 Inclusion and exclusion criteria are the conditions that
must be met in order to participate in a clinical triaI.
 The most important criteria used to determine
appropriateness for clinical trial participation include
age, sex, the type and stage of a disease, treatment
history, and other medical conditions.
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12. STUDY DESIGN :
 The design study section of the protocol should contain a
stepwise description of all procedures that required to by
study.
 A good study design section includes sufficient information
for the participating site.
 Parts of the study design section may include:
◦ Initial evaluations
◦ Screening tests
◦ Required lab tests
◦ Details of treatment or procedures
◦ Device specifications
◦ Dose scheduling and modification
◦ Calendars
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13. SAFTEY :
 Adverse effect and side effect are terms commonly
associated with drugs.They are used by nurses and
doctors, to refer to undesirable effects of a medication
on a patient.
 The Safety (or Adverse Events) section should include:
◦ Detailed information for reporting adverse events,
including reporting to the FDA and/or the sponsor
◦ Unblinding processes (if applicable)
◦ Lists of expected adverse events
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14. THE STATISTICAL SECTION:
 The study objectives and study design elements in the
statistical section should be described in the Objectives
section
 The descriptions and definitions of toxicities in the
statistical section match those in the Safety/AE section.
HUMAN SUBJECTS
PROTECTION :
 • This section includes discussion of:
◦ Subject selection and exclusion
◦ Proposed methods of patient recruitment
◦ Minority representation
◦ Recruitment (or exclusion) of special subjects, including
vulnerable subjects
◦ Lists of potential risks and benefits, including justification for
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15. Institutional Review Board /
Independent Ethics Committee
(IRB/IEC) :
 IRB/IEG serves as an independent body that reviews,
evaluates, approves and decides on the scientific and
ethical aspects of the clinical trial protocol as well as the
benefits and risks to the study participants
 Main purpose of IRB/IEG is to protect the rights, safety,
and well-being of the subjects who participate in a trial
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16. Composition of IRB/IEC :
 Consists of members, who collectively have the
qualifications and experience to review and evaluate the
science, medical aspects, and ethics of the trials.
 Includes at least five members, of which at least one
member whose primary area of interest is non-
scientific, and at least one member who is independent
of the institution/trial site.
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17. Responsibilities of IRB/IEC :
 Safeguard the rights, safety, and well-being of all trial
subjects.
 Reviews a proposed clinical trial within a reasonable
time and document its views in writing.
 Conducts continuing review of each ongoing trial at
least once per year.
 Ensures that information regarding payment to subjects
(including the methods, amounts, schedule of payment)
is set forth in the written informed consent form and
any other written information is provided to the
subjects.
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18. Procedures of IRB/IEC :
 Determines its composition and authority under which
it is established.
 Schedules, notifies its members of, and conducts its
meetings.
 Conducts initial and continuing review of trials.
 Specifies that no subject should be admitted to a trial
before the IRB/IEC issues its written approval or
favorable opinion of the trial.
 Specifies the information that the investigator should
report to the IRB/IEC (like deviations from the
protocol, adverse drug reactions etc).
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19. Maintenance of records of
IRB/IEC :
 IRB/IEG retains all relevant records (e.g., written
procedures, lists of occupations/affiliations of members,
submitted documents, minutes of meetings, etc.) for a
period of at least 3 years after complet of the trial and
makes them available upon request from the regulatory
authority(ies)
 IRB/IEG may be asked by investigators, sponsors, or
regulatory authorities to provide copies of its written
procedures and membership lists.
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20. Phases of Clinical Trial :
Phase I Phase II Phase III Phase IV
Design
features :
• Single,
ascending
dose tiers
• Unblinded
• Uncontrolle
d
• Placebo
controlled
comparisons
• Active
controlled
comparisons
• Well-defined
entry
criteria
• Randomize
d
• Controlled
• 2-3
treatment
arms
• Broader
eligibility
criteria
• Uncontroll
ed
• Observati
onal
Duration : Upto 1 month Several months Several years Ongoing
(following
FDA approval
Population
:
Healthy
volunteers or
individuals with
the target
disease (such as
cancer or HIV)
Individuals with
target disease
Individuals
with target
disease
Individuals
with target
disease, as
well as new
age groups,
genders, etc
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21. Sample
size:
20 to 80 200 to 300 100 to 1000 1000
Example: Study of a
single dose of
drug X in
normal
subjects
Double-bind
study
evaluating
safety and
efficacy of
drug X vs
Placebo in
patients with
hypertension
Study of drug
X vs Standard
treatment in
hypertension
study
Study of
economic
benefit of
newly
approved
drug X vs
Standard
treatment for
hypertension
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22. References :
 https://www.slideshare.net/mobile/ssuserfe3019/clinical-
trial-protocol-development Assessed Date: 25/02/2021
 https://www.slideshare.net/mobile/TSDP/institutional-
review-boardindependent-ethics-committee-irbiec
Assessed Date: 25/02/2021
 https://www.slideshare.net/mobile/ChintanDoshi17/clini
cal-trial-120090206 Assessed Date: 25/02/2021
 https://www.slideshare.net/mobile/uttara2024/clinical-
trials-types-and-design Assessed Date: 25/02/2021
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23. THANKYOU
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