Clinical Trials & its phases.

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, 1 st sem. Enrollment No. :- T1621PCE016 Department :- Pharmaceutics Institute :- P arul 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 :- C linical 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 – R are ADRs – Drug interactions – Also new uses for drugs [ Sometimes called Phase V]

9. 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.

10. 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.