DRUG SAFETY ASSESSMENT IN CLINICAL TRIALS: CONCEPTS AND ISSUESAbstract
Ensuring patient safety during and after clinical trials is the sole priority of the drug-development process. In both clinical trials and clinical practice, each patient must be treated according to his or her illness and needs. For this purpose, monitoring of patient safety at all levels of drug-development is given utmost importance. Such monitoring is a dynamic process having motive of protecting trial volunteers and patients from preventable harm during and after clinical trials respectively. For this purpose, knowledge of the basics of drug safety at all levels is essential especially for the healthcare professionals. Many literatures have been published on drug safety and clinical trials but a systemic document focusing strictly on all the dimensions is lacking. In this article, we have discussed upon all aspects of drug safety in clinical trials including the basics of drug safety, patient suitability for safety in trials, regulatory aspects of drug safety, causality, risk assessment and post marketing safety of the drug products.
Naveen Nautiyal*, Rajul Rastogi and Hans-Joachim Gamperl
Global vigilance, Fresenius Kabi Oncology Limited, Gurgaon, Haryana, India
13 March, 2015
13 May, 2015
21 June, 2015
01 October, 2015