Overview of clinical trials in medicine

Overview of clinical trials in medicine

1. Overview of Clinical Trials in India Dr. S. C. Pradhan , Senior Professor & Head, Department of Pharmacology, JIPMER, Puducherry .

2. Definition of Clinical Trial - UK According to UK Medicines Act of 1968, clinical trial is an investigation or series of investigations which “consists of the administration of one or more medicinal products by, or under the direction of , a doctor or dentist to patients, where there is evidence that the products have effects which may be beneficial to the patients, and the administration is for the purpose of ascertaining whether, or to what extent, the products have those or any other effects, whether beneficial or harmful (i.e. the assessment of efficacy and risks)” This definition could be modified to include other therapeutic procedures (such as a surgical operation).

3. Definition of Clinical Trial - India According to Drugs and Cosmetics (Seventh Amendment) Rules 2015, Clinical trial means “A systematic study of any new drug(s), in human subjects to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objectives of determining safety and/or efficacy of the new drug.”

4. Objectives of CME To introduce the basic principles of conducting clinical trials in Indian context (Why & How?) To set the goal to provide safe & effective medicines at affordable prices. To orient delegates to research methods and designs of clinical trials. To provide an overview of the recent amendments in the rules and regulations of conducting clinical trials in India. To sensitize the participants on the ethical issues involved in conducting clinical trials.

5. Concept of a New Drug A new chemical entity (NCE) or Investigational new Drug (IND) A new indication of an old drug A new combination A new derivative of a drug

6. Why in Indian Context? India is emerging as hub for clinical trials. As no. of clinical trials is on the rise, issues associated with them are increasing. Role of CROs in conducting trials is expanding (Research on hire). Recently, many amendments are made in the rules and regulations of conducting clinical trials in India.

7. What will you be learning in this CME? Ethical issues in clinical trials. Phases of clinical trials (phase 0, 1, 2, 3 & 4) Study designs of clinical trials. Rules and regulations governing the conduct of clinical trials in India (Schedule Y and the recent amendments). Postmarketing surveillance and monitoring of adverse effects. Role of pharmacogenomics in clinical trials.

8. Dhanyavad Thank you Nandri Merci