CME ON CLINICAL RESEARCH

Safety and efficacy are the two major concerns for any drug therapy. Globally clinical research plays an inevitable role in bringing a new molecule into the market after its synthesis by the pharmaceutical industries. Availability of large patient population, highly educated and skilled manpower, wide spectrum of diseases and favorable economic environment imply India’s potential as a global hub for clinical research. Pharmaceutical companies and Clinical Research Organization (CRO)s will require many trained personnel to carry out the clinical research. Keeping in mind these facts a CME with the theme of “Clinical research” had been jointly organized by the Dept of pharmacology, K.L.E University’s J.N.M.C, Belgaum and Indian Pharmacological Society (I.P.S), Belgaum branch on 20th February 2010. In the first scientific session, Dr.P.A.Patil (JNMC) spoke on “Preclinical studies”. In vitro and in vivo experiments of various doses of ‘study drug’ can obtain preliminary efficacy, toxicity and pharmacokinetic information suggesting the scientific merit for further development as an investigational new drug (IND). Local or systemic toxicity studies can be conducted (ex: urine analysis, blood biochemical assay, gross and microscopic pathology etc). Dr. B.J. Mahendra Kumar (KLE University’s College of pharmacy) talked on “Role of Drug Controller General of India (DCGI) in Clinical Trials”. He explained about Drug and cosmetic acts/rules, requirements/guidelines for permission to import and/or to manufacture new drugs or to undertake clinical trials i.e. Schedule Y and its appendices. Dr.N.M.Patil (JNMC) elaborated about “Ethical issues in clinical trials”. Ethics is required to: avoid exploitation of the subjects (maintain safety and wellbeing), protect vulnerable groups, children, disabled, elderly etc. Independent Ethics Committees (IEC) and Institutional Review Boards (IRB) are concerned with medical ethics. IECs review, regulate, monitor and supervise the clinical trials or the research projects. Ethical decision is taken without coercion, influence, inducement and intimidation. Dr.S.S.Torgal (JNMC) spoke on “Introduction to clinical trials”. A systematic study of a new drug in human subjects to generate data for discovering and/or verifying the clinical, pharmacological (pharmacodynamic / pharmacokinetic) and/or adverse effects with the objective of determining safety and/or efficacy of the new drug is known as clinical trial (Phase I, II, III and IV). There are many types of trials viz., Prevention trials, Screening trials, Diagnostic trials, Treatment tri