Clinical Trials and Pharmacovigilance

Dr. Suresh. K. Gupta, Manoj Sharma

World Health Organisation (WHO) defines pharmacovigilance as ‘the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem.1 The U.K. MHRA (Medicines and Health care products Regulatory Agency) referred it as `a technical term used for identifying and responding to risk /benefit issues emerging for authorised medicines as used in clinical practice, and including the effective dissemination of such information to optimise the safe and effective use of medicines.2

During drug development process pharmacovigilance include continuous monitoring and evaluation of all adverse events with or without a causal relationship to the investigational medicinal product (IMP) and any adverse drug reaction to concomitant medication to ensure the safety of the participants (subjects) and a continual assessment of the risk and the benefit. Based on the results from clinical trials and various other studies (during post authorization phase in large number of population) conducted in a setting of clinical trials a large number of drug withdrawals (e.g. Sibutramine, Efalizumab, Rofecoxib) have been made recently. Other long-term clinical trial have suggested that long-term use of a non-selective NSAID, naproxen which was sold as Aleve, Naprosyn and other trade name and generic products may be associated with an increased cardiovascular risk compared to placebo. Also, warnings to the drugs have been added based on the clinical trials conducted during post authorization phase in large number of population.

These advisories and recalls forms the basis for understanding of role of pharmacovigilance during the clinical trial process (clinical research) especially when continuous advancement and introduction of new treatment approaches worldwide has widened pharmacovigilance concerns to include traditional and complementary medicines, herbals, medical devices, blood products, biological, and vaccines.


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