Role of Post Approval Clinical Trials for Drug Safety in India

Abstract

Clinical trials are prospective biomedical or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions (novel vaccines, drugs, treatments, functional foods, dietary supplements, devices or new ways of using known interventions), generating safety and efficacy data. Developing a new drug requires great amount of research work in chemistry, manufacturing, controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. As positive safety and efficacy data are gathered, the number of patients typically increases. Clinical trials can vary in size, and can involve a single research entity in one country or multiple entities in multiple countries. A full series of trials may cost hundreds of millions of dollars. The burden of paying is usually borne by the sponsor, which may be a governmental organization or a pharmaceutical, biotechnology or medical device company. When the required support exceeds the sponsor's capacity, the trial may be managed by an outsourced partner, such as a contract research organization or an academic clinical trials unit. EU pharmaceutical legislation requires the European Medicines Agency (EMA), which maintains the Eudra CT database on behalf of EU member states to provide information held in EudraCT to the public. This is described in article 57 of Regulation (EC) No 726/2004 and article 41 of the Paediatric Regulation (EC) No 1901/2006. Together, they established that data on clinical trials conducted in adults and in paediatric populations be made public.