Assessment of Prevailing Insurance Policies and Regulations in Context of Clinical Research Industry

Abstract

Clinical trials play a major role in the process of drug discovery. It is mandated by the Food and Drug Administration (FDA), which aids in determining the safety and efficacy of investigational product (IP) prior to its marketing for mass consumption. The clinical trial site may be a research hospital, contract research organization (CRO) or any medical institute which allow subjects to access interventions not yet accessible to the mass population. Although human research give a ray of hope for the discovery of new drug, it also resulting in litigation against all the stakeholders of clinical study. This review explores the clinical trial liability exposure of subjects, and all other concerned stakeholders and also the mitigation strategies for this exposures and the prevailing misconceptions about insurance coverage. At the same time this article presents common clinical research scenarios that pose concern for fraud and abuse and offers suggestions for various relevant amendments required to bridge the gap.