A summary of clinical trial . Its regulations & summary of all the phase in clinical trial.

1. Suraj p.s
1st M.pharm
Regulatory
Affairs
JSS college

2.  A Systematic Investigation in Human
Subjects for evaluating the Safety &
Efficacy of any New Drug.
 Clinical Trial is the main stay for
bringing out New Drugs to the Market.
 It takes Approx. 10-12 Years & USD 800
Mio to bring one New Drug to the Market.
 For Every 10,000 – 30,000 drug
molecules screened, only 1 reaches to

3. PHASES INVOLVED CLINICAL TRIALS
PRE-CLINICAL STUDIES
PHASE 0
PHASE 1
PHASE 2
PHASE 3
PHASE 4
PHASE 5

4. PRE-CLINICAL STUDIES
 Before pharmaceutical companies start clinical
trials on a drug, they conduct extensive pre-
clinical studies.
 These involve in vitro (test tube or cell culture)
and in vivo(animal) experiments using wide-
ranging doses of the study drug to obtain
preliminary efficacy, toxicity and pharmacokinetic
information.
 Such tests assist pharmaceutical companies to
decide whether a drug candidate has scientific
merit for further development as
an investigational new drug.

6. PHASE 0
 Phase 0 trials are also known as human micro-
dosing studies and are designed to speed up the
development of promising drugs or imaging
agents by establishing very early on whether the
drug or agent behaves in human subjects as was
expected from preclinical studies.
 Drug development companies carry out Phase 0
studies to rank drug candidates in order to decide
which has the best pharmacokinetic parameters
in humans to take forward into further
development.
 They enable go/no-go decisions to be based on
relevant human models instead of relying on
sometimes inconsistent animal data

7. PHASE 1
 Phase 1 trials are the
first stage of testing in
human subjects.
Normally, a small group
of 20–100 healthy
volunteers will be
recruited.
 This phase is designed
to assess the safety,
tolerability,
pharmacokinetics, and
pharmacodynamics of
a drug.

8. PHASE 2
 Phase 2 trials are performed on larger groups
(100-300) and are designed to assess how well
the drug works, as well as to continue Phase 1
safety assessments in a larger group of
volunteers and patients.
 Phase 2 studies are sometimes divided into
Phase 2A and Phase 2B.
1. Phase 2A is specifically designed to assess dosing
requirements (how much drug should be given).
2. Phase 2B is specifically designed to study efficacy (how
well the drug works at the prescribed dose)
 Some trials combine Phase 1 and Phase 2, and
test both efficacy and toxicity

9. PHASE 3
 Phase 3 studies are randomized
controlled multicenter trials on large patient
groups (300–3,000 or more depending upon the
disease/medical condition studied) and are aimed
at being the definitive assessment of how
effective the drug is, in comparison with current
'gold standard' treatment.
 Designed to evaluate the effectiveness of the new
treatment compared to standard treatment.
Participants are assigned by chance to either an
investigational group, and given the new
treatment; or to a control group, and given
standard treatment.

10. PHASE 4
 Phase 4 trial is also known as post-
marketing surveillance Trial.
 Phase 4 trials involve the safety
surveillance (pharmaco-vigilance) and
ongoing technical support of a drug after
it receives permission to be sold.
 Designed to further track side effects and
benefits on a long-term basis after a drug
has been FDA-approved.

11. PHASE 5
 Phase 5 is a growing term used in the
literature of translational research to refer
to comparative effectiveness research
and community-based research; it is used
to signify the integration of a new clinical
treatment into widespread public health
practice.