25 Feb : Ms.Priyanka Verma from Pfizer initiated the fifth day’s proceeding with topic on Clinical trial monitoring. It is one of the important responsibilities of the sponsor which ensures the quality control of the data generated form the clinical trials. Clinical trial associates / monitors are appointed by the sponsor to monitor the clinical trial and they are a very important link between the sponsor and the investigator. The monitor looks at all the records of each and every patient enrolled in the trial. She also deliberated lecture on Clinical Trial Regulations in India. To conduct clinical trials in India, one must follow the schedule Y of Drugs and Cosmetics Act, which mandates following Indian GCP (drafted in 2001 by the Drugs Controller General of India) and the ICMR guidelines for biomedical research. She also spoke about international regulations in different parts of the world like USA and European Union.
Dr.V. Batra also from Pfizer spoke on Clinical Trial Audit and inspections. The sponsor (pharmaceutical company) conducts these audits at the clinical trial site to scrutinize the data files for their integrity and completeness. Inspections are generally conducted by the regulatory authorities like Drugs Controller General of India or the US, FDA. The purpose of monitoring, audits and inspections is to ensure that patient’s safety is not compromised at any step and to assist the investigators in conducting the clinical trial as per protocol.
Dr.Nusrat Shafiq, Assistant Professor of the department of Pharmacology spoke on Evidence based medicine. She spoke on the different steps of reaching an evidence based answer to a clinical query that include asking a relevant answerable clinical question, searching the sources of evidence, compiling the available research evidence and clinical evidence with patient preferences to reach a decision for a specific patient. The delegates were given hands on exercises to construct a question and search for the answer to that question.