A. SUJATHA

A. SUJATHA

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  CLINICAL TRAILS SUBMITTED TO Dr. G.RAMESH (Pharm d) SUBMITTED BY A.SUJATHA 18AB1T0101
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  Slide Title .DEFINTION: “A clinicaltrial is a research study designed to test the safety and effectiveness of new treatments for cancer. Every cancer-fighting drug and therapy available to doctors today had to be tested in a clinical trial before it could be used routinely on patients.”
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  Phase1(20-80 volunteers) • (Normalvolunteers) • (several months) • The test is designed to determine • 1.whether there occur a difference in pharmacokinetic response to drug in humans and animals • 2.the maximum tolerated dose and safety of the drugs i.e., the therapeutic dose of the drug • 3.the different pharmacodynamic parameters • 4.To detect the adverse/toxic effect of the new drugs
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  Phase II(20-300 volunteers •(selected patient) • (months to years) • .To determine dose metabolism and kinetics of the new drugs. • Phase II trials are conducted on large group of volunteers ranging between 20-300. it is the first trials in which the drugs is studied in patient with specific target disease • This phase is mainly used to determine the therapeutic efficacy, safety, ADRs, final dose rang and dosage form. it is further divided into early and late phase
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  • 1.Early phase •This phase is mainly designed to determine the dosage requirement. The number of volunteers selected for this purpose vary form 20-200. the trials design followed is signals blind, where the volunteers is unaware whether he is being given a placebo or a standard drugs(control) or the investigational new drugs. Therapeutic uses and side effects of the drugs are explored in this phase. • 2 late phase • It is designed to study the efficacy of a drug for which 50-300 volunteers are selected. Doubles blind design is followed in the late phase
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  Phase III(300-3000 volunteers) •(large numbers of selected patients) • (1-5 years) • To determine safety and efficacy of the new drug and reduce the errors of phase I and phase II trials. • These trials are usually expensive, time-consuming and difficult to conduct. Therapeutic value of the drug is confirmed in this phase. It also provides information about additional safety, • Adverse effects, drugs interactions and pharmacokinetics of the new drug.
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  The trial designused here is Randomized controlled multicenter trial and double-blind cross-over design. 1.Randomization Initially, the volunteers are divided in two different groups by randomization method. The investigational drugs is administered to one group while the other groups receives a standard drugs and the results are compared.
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  • 2 Double-blind cross-over design • A Cross- over design is the one in which the volunteers is initially administered the investigational new drug. After a wash-out period i.e. 7 days, standard drugs is administered. Thus, in this design the volunteers acts as his own control, thereby reducing any individual variations.
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  • In thisdesign the investiganal drugs, placebo and standard drugs are administered alternatively each treatment lasting for nearly • 7days with an interval of one week to allow time for the medicine to get washed out. In this way each and every volunteer receives all the three treatments. week Grou p1 Grou p2 Grou p3 week 1 stand ard place bo New drugs week 2 place bo New drugs stand ard week 3 New drugs Stand ard drugs place bo
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  • These trialsare generally conducted by physicians/ clinicals at clinical centers. • This process usually takes nearly five years to complete. once the results are obtained, • Simple statistics like student t-test and chi-square tests are performed. • The other difficult statistics like analysis of variance, covariance, non-parametric are also done.
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  • Phase IIIis completion, • New drug application(NDA) is filed and sumitted to the concerned authorities for licensing. • This applications includes all the details about the investigational drug, • The monograph of the product, results of trials, trial process, the proposed name of the product, its packaging details etc. • Once this application is accepted and is in compliance with the regulations, the authorities give permission to release the drug into market.
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  • phaseIV(patient givendrug therapy) • To determineADRs of new marketed drugs • phaseIV clinical trials are knowns as post-marketing surveillance trials. • After the approval of the new drug for marketing, phaseIV trials begin. It is also known as post licensing period. • In this trials, data about the efficacy and adverse effects are collected form the practising physicians.
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  • These trialsare performed on large number of patients and for a long time, during which rare and long term adverse effects, unexpected drug interactions, unexpected clinical uses of the drug can be discovered. • This phase has no fixed duration. • If any harmful or life threatening effect are noticed during this course the drug is restricted form being sold in the market. • Example; cerivastatin(anti hyperli • pidemic) marketed under trade names Baycol and lipobay, has been removed form the markets as it caused sever muscle degeneration.