INTRODUCTION TO CLINICAL TRIAL. Dr.K.T. Manisenthil Kumar, Head, Department of pharmacology, KMCH college of pharmacy, Coimbatore, Tamilnadu, India.

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1 INTRODUCTION TO CLINICAL TRIAL Dr.K.T. Manisenthil Kumar, Head, Department of pharmacology, KMCH college of pharmacy, Coimbatore, Tamilnadu, India.

2 INTRODUCTION The safety and toxicity data generated from preclinical studies enables the drug company to safely initiate clinical trials. The scope and duration of this trials will vary widely, depending on the nature of the drug and its therapeutic application.

3 Clinical trials on patients in the different countries are approved and monitored by different regulatory agencies like: In India, Drug Controller General Of India(DCGI) office under Central Drug Standard Control Organisation (CDSCO). In UK Medicines And Healthcare products Regulatory agency (MHRA) advised by the committee on safety of medicines. In USA Food And Drug Administration(FDA).

4 A clinical trial process requires a lot of money, time, resources, and sound planning. So most companies put together a clinical development plan before starting a clinical study. A clinical development plan is a comprehensive plan designed to map out the development of a drug compound from early phase 1 studies through marketing.

5 A clinical trials evaluate new drugs, medical devices, biologics or other interventions on patients in strictly scientifically controlled settings and are required for regulatory authority approval of new therapies. Trials may be designed to Assess the safety and efficacy of an experimental therapy to assess whether the new intervention is better than standard therapy or To compare the efficacy of two standard or marketted interventions.

6 DEFINITION A clinical trial is a planned experiment that involves volunteers and is designed to determine the most appropriate treatment for the future patients with a given medical condition.

7 PHASES OF CLINICAL TRIAL Clinical trials are commonly classified into four phases. Phase I Phase II Phase III Phase IV

8 PHASE I Mainly used to find out the safety of drug in humans. Test the investigational product in healthy volunteers. Generally conducted on healthy human volunteers and typically for 5 months.

9 Initially a small dose is administered to each volunteer in a hospital-type setting, so that the effects of the drug can be closely monitored. If the drug has a potential for toxic adverse events, it may be given only to subjects with the targeted condition to reduce the risks to healthy subjects. The main purpose of the initial phase I studies is to establish a safe dosage range.

10 These studies are used to determine The metabolic and pharmacologic actions of the drug in humans. The side effects associated with increasing doses. If possible to gain early evidence on effectiveness. To establish a safe dosage range. Also evaluate drug metabolism, structure activity relationships, and mechanism of action

11 During phase I, sufficient information's about the drug s pharmacokinetics (ADME) and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, phase II studies. Only about 70% of experimental drugs passes phase I clinical trials.

12 Phase I trial address How rapidly the dug is absorbed? Where is the drug distributed in the body? Which organs or organ systems are involved in metabolism of the drug? How quickly is the drug eliminated from the body?

13 Phase II Phase II clinical trial are conducted on patients. Main question asked by phase II studies is: what is the most protective dosage range and is the drug safe within the range. Phase II studies enroll small numbers of subjects, typically 100 to 300 and the trial may last from 6 months to 2 years.

14 The primary aims of phase II trials are: To establish clinical efficacy Determine the incidence of adverse reactions Define the optimum therapeutic dosage Provide detailed pharmacokinetic and pharmacological data to substantiate the adequate trial of the drug.

15 Trials on patients may be conducted in an open, nonblind, manner where the patients know whether they are receiving a placebo or a drug. In single blind trials, only patients do not know whether they are receiving the drug or the placebo. In double blind trials, both the patients and the clinical investigators do not know which agent the patient is receiving.

16 Phase II trial address what is the minimum effective dose? what is the maximum tolerated effective dose? Is the drug effective in mild, moderate, and severe cases of the disease or condition? Is the drug effective for all expected indications?

17 Phase III Phase III trials are expanded controlled and uncontrolled trials. They are intended to gather the additional information's about effectiveness and safety. Phase III involves several hundreds to thousands patients and lasts 1-5 years.

18 The main aim of this study are : To verify the drug effectiveness and any adverse drug reactions in a large patients over a longer period of exposure, To establish safety and efficacy of the drug. Also provide adequate basis for extrapolating the results to the general populations and transmitting that information in the package insert.

19 In both phase II and phase III, regulatory bodies can impose a clinical hold if a clinical study is unsafe, or if the protocol is clearly deficient in meeting its stated objectives. Once the phase III clinical trial has been completed satisfactorily, the drug company is in a position to apply the marketing application to the regulatory authorities to market the drug.

20 Phase III trial address Overall benefit risk relationship Adverse reactions in a large group of patients over a longer period of exposure. The ideal dosage regimen. Should the drug is allowed to be marketed?

21 Phase IV (Post marketing surveillance) Phase IV trial involve the post launch safety surveillance and ongoing technical support of a drug. Post marketing surveillance is designed to detect any rare or long term adverse effects over a much larger patient population and a timescale than as possible during the initial trial. An adverse effect detected by phase IV trials may result in the withdrawal or restriction of a drug.

22 Phase IV trial address More about the side effects and safety of the drug What the long term risks and benefits of the drug are? How well the drug works when it s used more widely than in clinical trials?

23

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