DIFFERENT PHASES OF CLINICAL TRIALS WITH ELEMENTS TO BE EVALUATED

1. SUBMITTED BY UNDER THE GUIDANCE OF
DASARI NIROOSHA Dr. G.RAMESH Pharm.d
15AB1T0005 DEPARTMENT OF
IV PHARM. D PHARMACY PRACTICE
DIFFERENT PHASES OF CLINICAL
TRAILS WITH ELEMENTS TO BE
EVALUATED
VIGNAN PHARMACY COLLEGE
(Approved by AICTE & PCI Affiliated to JNTU KAKINADA)
VADLAMUDI, GUNTUR DIST, ANDHRA PRADESH, INDIA, PIN: 522 213

2. INTRODUCTION:
 Clinical trials are conducted to collect data
regarding the safety and efficacy of new
drug and device development.
 There are several steps and stages of
approval in the clinical trials process before
a drug or device can be sold in the consumer
market, if ever.
 Drug and device testing begins with
extensive laboratory research which can
involve years of experiments in animals and
human cells.
 If the initial laboratory research is
successful, researches send the data to the
Food and Drug Administration (FDA) for
approval to continue research and testing in
humans.

3. “A clinical trial is a
biomedical or health-
related research studies
in human beings that
follow a pre-defined
protocol. It is an
experiment; not first in
line to therapy.”

4. There are two main types of clinical trials - observational and interventional
 Observational clinical trials do not test drugs or treatments. Researchers
observe participants by monitoring their health over a period of time. These
studies provide researchers with data that advances our understanding and how
to treat the disease.
 Interventional clinical trials test the safety and effectiveness of a candidate
drug, therapy or experimental treatment.

Within these broad categories, trials also can be classified as follows:
 Treatment trials test treatments, drug combinations or surgical approaches to
alleviate symptoms and/or slow disease progression in people
 Prevention trials test approaches, medicines, vitamins, minerals, vaccines or
lifestyle changes that may lower the risk of developing disease.
 Screening trials test ways to detect disease, particularly in its early stages.
 Quality of Life trials explore ways to improve comfort and quality of life.
 Genetics trials are designed to improve the ability to look for an inherited risks
of disease.

5.  The development of investigational new drugs (INDs) involves performing
clinical trials (or studies) to assess the safety and efficacy of the IND in
humans.
 These trials are usually classified into 4 phases of development (Phase 1 to 4),
with each potentially lasting for several years.
 Successful completion of each phase and approval by the appropriate
regulatory authority or authorities (the European Medicines Agency [EMA] in
the European Union, Food and Drug Administration [FDA] in the United
States, Health Canada in Canada, or the Ministry of Health, Labour and
Welfare in Japan) is required for progression to the next phase.
 Satisfactory completion and approval of Phases 1 to 3 is required for a
drug to be approved for marketing. Phase 4 studies are conducted after a
compound has been approved, for the primary purpose of post marketing
surveillance.
 In an attempt to both speed up the drug development process and to quickly
identify safety issues, Phase 0 studies, also referred to as ‘human microdosing
studies’ were introduced

7. Phase I: Initial safety trials on a new medicine. An attempt is made to
establish the dose range tolerated by volunteers for single and for
multiple doses.
• Pharmacokinetic trials are usually considered Phase I trials regardless
of when they are conducted during a medicine's development.
Phase IIa: Pilot clinical trials to evaluate efficacy ( and safety) in selected
populations of patients with the disease or condition to be treated,
diagnosed, or prevented.
• Objectives may focus on dose-response, type of patient, frequency of
dosing, or numerous other characteristics of safety and efficacy.
Phase IIb: Well controlled trials to evaluate efficacy ( and safety) in
patients with the disease or condition to be treated, diagnosed, or
prevented.
• These clinical trials usually represent the most rigorous demonstration
of a medicine's efficacy. Sometimes referred to as pivotal trials.

8. Phase IIIa: Trials conducted after efficacy of the medicine is demonstrated,
but prior to regulatory submission of a New Drug Application (NDA) or
other dossier.
• These clinical trials are conducted in patient populations for which the
medicine is eventually intended.
Phase IIIb: Clinical trials conducted after regulatory submission of an NDA
or other dossier, but prior to the medicine's approval and launch.
• This is the period between submission and approval of a regulatory dossier
for marketing authorization.
Phase IV: Studies or trials conducted after a medicine is marketed to provide
additional details about the medicine's efficacy or safety profile. Different
formulations, dosages, durations of treatment, medicine interactions, and
other medicine comparisons may be evaluated.
• The term post-marketing surveillance is frequently used to describe those
clinical studies in Phase IV (i.e., the period following marketing

9. WHAT HAPPENS WHEN A TRIAL IS OVER?
• Once a clinical trial is over, the trial team assesses the
data, distills key findings, publishes or presents any novel
findings and determines the appropriate next steps for
future testing, as appropriate.
• They may continue to evaluate the treatment in the next
trial or discontinue research because the treatment has not
been shown to be safe or effective.
• In some cases, if the treatment continues to the next
phase, trial participants will be given the option of
participating in that phase of the study as well.

10. TRIAL TEAM:
 A trial team can consist of a principle
investigator, study coordinator,
research assistant, research nurses or
other members of the research
institution’s team conducting the
study.
 The members of this team are
responsible for running the trial at a
particular trial site. Depending on the
size of the trial, trial teams vary in
size.
 Trial teams are the best resource to
learn more about what is involved in a
study and to ask questions of when
you are considering trial participation

11. ADVANTAGES OF CLINICAL TRIALS:
•Often provides the strongest evidence in
support of cause-effect relationships
•Basis for clinical and public health policy
• Minimize/eliminate bias