The 30th National Workshop on Clinical Pharmacology organized by the Department of Pharmacology, PGIMER, Chandigarh began today. Head of the department Prof. A Chakrabarti welcomed the delegates and informed that in this workshop nearly 70 delegates from all over India are participating. Prof. Chakrabarti further informed that the delegates include faculty members as well as students undergoing their postgraduate training. Eminent scientists from academic institutions and pharmaceutical industry (Pfizer, Novartis, Dr Reddy’s, Themis, Torrent,) have been invited from all over the country to share their experiences. He stressed on the importance of trained and experienced clinical pharmacologist’s in development of standards pertaining to scientific , ethical and legal aspects of conducting clinical trials in the present Indian scenario. The aim of conducting this workshop is to provide an overview of the scientific, ethical and legal conduct of clinical research.
In the first lecture of the day, Dr Shibadas Biswal, from Novartis elaborated his experiences in investigational new drug (IND) application submission to the regularity agencies like DCGI in India and USA FDA. He discussed the contents of an IND application which is submitted to the regulatory agencies. He stressed on the importance of the conducting and evaluating preclinical (animal studies) data before introducing the drug in humans. Such data should include pharmaceutical formulation development, general and specific pharmacological action of the new molecular entity, non-clinical safety. He also discussed the roles of individuals involved from multiple disciplines in the whole process.
Additionally Dr Shibadas, spoke on Phase I and Phase 2 clinical trials. These are studies in which a new drug is given for the first time to healthy volunteers after a lot of testing in experimental animals. He spoke regarding the use of group of healthy volunteers in the trial design to assess the safety tolerability, pharmacokinetics and pharmacodynamics of a drug and also regarding dose ranging. He explained about the different kinds of phase I trials like single ascending dose studies, multiple ascending dose studies and food effects on the drug kinetics. Only if the drug is found to be safe it is allowed to be tested further phase II trials. The number of patients in phase II trials is usually small (several hundred).These studies also help in optimizing the dosage schedule to be used in the confirmatory clinical trials.
Dr. P.L. Sharma, Former Dean PGI delivered lecture on topic “ Phase III and IV clinical trials”. Phase III trials are those studies in which a new drug is evaluated in larger patient populations to confirm the efficacy. In phase III, the new drug is tested on larger number of patients (in thousands) and with broader characteristics. At the end of phase III, if the drug is found to be safe and effective, the company files an application with the regulators (Drugs Controller General of India) for obtaining permission to market the drug.
Dr Nusrat Shafiq Assistant Professor, Department of Pharmacology, PGI spoke on Protocol Design. She gave extensive workup of the various aspects of protocol design and terminology used in designing of protocols for the conduct of clinical trials. She also told the delegates that unless the trial is properly planned and all the information about the trial is documented in the protocol, the chances of successfully conducting a trial are negligible and the results obtained will not be valid and clinically applicable. Dr Smita Pattanaik Assistant Professor, Department of Pharmacology ,PGI delivered a lecture on clinical studies involving populations of special concerns like children, pregnant women and patients with specific disease conditions like hepatic and renal impairment.
In the evening, the delegates had a hands on experience in Pharmacokinetic/ Pharmacodynamic exercises and discussed various clinical research problems.