Presented By :- Raghav Sharma Class :- M.Pharm, 1st sem. Department :- Pharmaceutics Institute :- Parul Institute of Pharmacy Content :- Introduction to Clinical trials Importance of Clinical Trials Phase-I of Clinical Trials Phase-II of Clinical Trials Phase-III of Clinical Trials Phase-IV of Clinical Trials Conclusion References

1. Clinical Trials
Presented By :- Raghav Sharma
Class :- M.Pharm, 1st sem.
Enrollment No. :- T1621PCE016
Department :- Pharmaceutics
Institute :- Parul Institute of Pharmacy

2. CONTENT :-
 Introduction to Clinical trials
 Importance of Clinical Trials
 Phase-I of Clinical Trials
 Phase-II of Clinical Trials
 Phase-III of Clinical Trials
 Phase-IV of Clinical Trials
 Conclusion
 References

3. Clinical Trials :-
Clinical trials are research studies performed in people
that are aimed at evaluating a medical, surgical, or
behavioral intervention. They are the primary way that
researchers find out if a new treatment, like a new drug
or diet or medical device is safe and effective in people.
Often a clinical trial is used to learn if a new treatment
is more effective and/or has less harmful side
effects than the standard treatment.
They are conducted only after they have received
health authority/ethics committee approval in the
country where approval of the therapy is sought.

4. Importance of clinical trials :-
Clinical trial helps in getting details about :-
 Drug input
 Pharmacokinetics
 Pharmacodynamics
 Pharmacogenetics
 Pharmacogenomics
 Factors affecting Drug response and finally
 The toxicity and side effects

5. Phase I clinical trial :- (By clinical Pharmacologist )
Objectives :-
To assess safe & tolerated dose
To see if pharmacokinetics differ much from animal to man
To see if kinetics show proper absorption, bioavailability
To detect effects unrelated to the expected action
To detect any predictable toxicity
Inclusion criteria :-
Healthy volunteers - Uniformity of subjects: age, sex, nutritional
status [Informed consent a must]
Exception - Patients only for toxic drugs E.g. AntiHIV, Anticancer
Exclusion criteria :-
Women of child bearing age, children,

6. Phase II clinical trial :- (By clinical Pharmacologist )
 First in patient [ different from healthy volunteer]
 Early phase [20 – 200 patients with relevant disease] :-
-- Therapeutic benefits & ADRs evaluated.
-- Establish a dose range to be used in late phase.
-- Single blind [Only patient knows] comparison with
standard drug.
 Late phase [ 50 – 500] :-
-- Double blind.
-- Compared with a placebo or standard drug.
 Outcomes :-
-- Assesses efficacy against a defined therapeutic endpoint
-- Detailed pharmacokinetic & Pharmacodynamics data
-- Establishes a dose & a dosage form for future trials
 Takes 6 months to 2 years [ 35% success rate]

7. Phase III clinical trial :- (By clinical Investigators)
 Large scale, Randomized, Controlled trials
 Target population: 250 – 1000 patients
 Performed by Clinicians in the hospital
 Minimizes errors of phases I and II
 Methods :-
– Metacentric - Ensures geographic & ethnic variations
– Diff patient subgroups E.g. pediatric, geriatric, renal
impaired
– Randomized allocation of test drug /placebo / standard drug
– Double blinded
– Cross over design
– Vigilant recording of all adverse drug reactions
– Rigorous statistical evaluation of all clinical data
 Takes a long time: up to 5 years [25% success]

8. Phase IV or Post marketing Surveillance :-
(Post marketing Surveillance by Practicing Clinicians)
 No fixed duration / patient population
 Starts immediately after marketing
 Report all ADRs
 Helps to detect
– Rare ADRs
– Drug interactions
– Also new uses for drugs
[Sometimes called Phase V]

10. Conclusion :-
 Clinical trial is the scientific study of drugs in man.
 Based on the results obtained from the animal experiments,
the mechanism of action, potential therapeutic application,
approximate dose range and possible toxicities are first
established for a compound under investigations.
 These results are then translated in the humans in a cautious
manner that form the basis of clinical pharmacology which
deals with Drug input, Pharmacokinetics,
Pharmacodynamics, Pharmacogenetics, Pharmacogenomics,
Factors affecting Drug response.
 Toxicity and side effects.

11. References :-
 M.N. Gosh, (2008) Fundamentals of Experimental
Pharmacology,4th Edition, Hilton and Company, Kolkata.
 S.K. Kulkarni, (2012) Handbook of Experimental
Pharmacology, 4th Edition, Vallabh Prakashan, Delhi.
 Breckenridge, A.M. (1980) Br. Med. J. 280,1303.
 Greenwood, D.T. and Todd, A.H.(1977) In Clinical
Trials.Johnson, F.N. and Johnson, S.Blackwell Scientific
Publications, Oxfords.
 Guidelines for Clinical Trials on Pharmaceutical
Products in India(2201) Published by the Ministry of
health and Family Welfare, Government of India, New
Delhi.
 Melmon, K.L. and Morrelli, H.F.(1978) Clinical
Pharmacology: Basic Principles in Therapeutics, 2nd
Edition, Macmillan Publishing Company Inc. N.Y.