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Introduction to Clinical trial

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Introduction to Clinical trial

Introduction to Clinical trial

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  • 1. Presented by, Ms. Sonali B. Diwate Guided by, Prof. R. Chanshetti MODERN COLLEGE OF PHARMACY(FOR WOMEN), MOSHI, PUNE
  • 2. 1. Introduction to Clinical Trials 2. To understand the importance of Clinical Trials 3. To review and study Phase-I of Clinical Trials 4. To review and study Phase-II of Clinical Trials 5. To review and study Phase-III of Clinical Trials 6. To review and study Phase-IV of Clinical Trials 7. To Summarise the information To review and study Phases of Clinical Trials OBJECTIVES
  • 3. Sr No. Particulars 1 Aim and Objectives 2 Introduction to Clinical Trials 3 To understand the importance of Clinical Trials 4 To review and study Phase-I of Clinical Trials 5 To review and study Phase-II of Clinical Trials 6 To review and study Phase-III of Clinical Trials 7 To review and study Phase-IV of Clinical Trials 8 To Summarise the information C O N T E N T
  • 4. Introduction to Clinical Trial Trial is from the Anglo–French trier, meaning to try. Broadly, it refers to the action or process of putting something to a test or proof. Clinical is from clinic, from the French cliniqu´e and from the Greek klinike, and refers to the practice of caring for the sick at the bedside. Hence, narrowly, a clinical trial is the action or process of putting something to a test or proof at the bedside of the sick. However, broadly it refers to any testing done on human beings for the sake of determining the value of a treatment for the sick or for preventing disease or sickness. The clinical trial, in its simplest form, involves the application of the experimental variable- treatment to a person or group of persons and Observation during or following application of treatment to measures its effect.
  • 5. Importance to Clinical Trial Drug input, Pharmacokinetics, Pharmacodyanamics, Pharmacogenetics, Pharmacogenomics, Factors affecting Drug response and finally the toxicity and side effects It deals with
  • 6. Phase I : First in man  safety Phase II : First in patient dose, dosage form Phase III : Efficacy, ADRs Post marketing surveillance or Phase IV : Evaluation in the real clinical setting Assessment of a New Drug in man can be divided into 4 phases
  • 7. Objectives 1. To assess safe & tolerated dose 2. To see if pharmacokinetics differ much from animal to man 3. To see if kinetics show proper absorption, bioavailability 4. To detect effects unrelated to the expected action 5. 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 Eg AntiHIV, Anticancer – Exclusion criteria ◦ Women of child bearing age, children, Phase I Preclinical testing by clinical Pharmaco logist
  • 8. Methods: ◦ First in Man : Small number of healthy volunteers ◦ First in a small group of 20 to 25 ◦ Start with a dose of about 1/10 to 1/5 tolerated animal dose ◦ Slowly increase the dose to find a safe tolerated dose ◦ If safe  in a larger group of up to about 50 –75 ◦ No blinding ◦ Performed by clinical pharmacologists ◦ Centre has emergency care & facility for kinetics study ◦ Performed in a single centre ◦ Takes 3 – 6 months [ 70% success rate] Phase I contd
  • 9. 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 P.kinetic & P.dynamic data ◦ Establishes a dose & a dosage form for future trials Takes 6 months to 2 years [ 35% success rate] Phase II Clinical testing by clinical Pharmaco logist
  • 10. Large scale, Randomised, Controlled trials Target population: 250 – 1000 patients Performed by Clinicians in the hospital Minimises errors of phases I and II Methods ◦ Multicentric  Ensures geographic & ethnic variations ◦ Diff patient subgroups Eg pediatric, geriatric, renal impaired ◦ Randomised 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] Phase III Clinical Trials by clinical Investigators
  • 11. 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] Phase IV or Post marketing Surveillance Post marketing Surveillance by Practicing Clinicians
  • 12. Summary of clinical trial phases phase primary goal dose patient monitor typical number of participants notes Preclinical Nonhuman efficacy, toxicity and pharmacokinetic information unrestricted A graduate level researcher (Ph.D.) in vitro and in vivo animal Phase 0 Pharmacodynamics and Pharmacokinetics particularly oral bioavailability and half- life very small, subtherapeutic clinical researcher 10 people often skipped for phase I Phase I Testing of drug on healthy volunteers for dose-ranging often subtherapeutic, but with ascending doses clinical researcher 20-100 determines whether drug is safe to check for efficacy Phase II Testing of drug on patients to assess efficacy and safety therapeutic dose clinical researcher 100-300 determines whether drug can have any efficacy; at this point, the drug is not presumed to have any therapeutic effect whatsoever
  • 13. Phase III Testing of drug on patients to assess efficacy and safety therapeutic dose clinical researcher and personal physician 1000-2000 determines a drug's therapeutic effect; at this point, the drug is presumed to have some effect Phase IV Postmarketing surveillance - watching drug use in public therapeutic dose personal physician anyone seeking treatment from their physician watch drug's long term effects Phase V translational research no dosing none all reported use research on data collected phase primary goal dose patient monitor typical number of participants notes
  • 14. Informed consent form: ◦ Voluntary ◦ Explained in simple nontechnical language ◦ Translated in the native language of the subject ◦ Comprehensive information regarding the trials Benefit of new therapy over existing ones Alternative treatments available ◦ All possible adverse reactions ◦ Freedom to withdraw from the trial at any time, without giving any reason
  • 15. Compensation in drug related injuries ◦ Mild and Severe Patient Rights ◦ Confidentiality of data ◦ Right to withdraw Collection procedures & amount of biological material taken Compensation & Insurance claims Sending bio-material abroad Selection of Patients Problem areas
  • 16. 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, Pharmacodyanamics, Pharmacogenetics, Pharmacogenomics, Factors affecting Drug response and finally the toxicity and side effects
  • 17. Bibliography 1. M.N. Gosh, (2008) Fundamentals of Experimental Pharmacology,4th Edition, Hilton and Company, Kolkata. 2. S.K. Kulkarni, (2012) Handbook of Experimental Pharmacology, 4th Edition, Vallabh Prakashan, Delhi. 3. Breckenridge, A.M. (1980) Br. Med. J. 280,1303. 4. Greenwood, D.T. and Todd, A.H.(1977) In Clinical Trials.Johnson, F.N. and Johnson, S., eds.,Blackwell Scientific Publications, Oxfords. 5. Guidelines for Clinical Trials on Pharmaceutical Products in India(2201) Published by the Ministry of health and Family Welfare, Government of India, New Delhi. 6. Melmon, K.L. and Morrelli, H.F.(1978) Clinical Pharmacology: Basic Principles in Therapeutics, 2nd Edition, Macmillan Publishing Company Inc. N.Y.
  • 18. THANK YOU ALL THANK YOU ALL THANK YOU ALL THANK YOU ALL

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