Pintail Usharani, Syed Mujtaba Hussain Naqvi | Perspectives in Clinical Research | PubMed Central (PMC) | NCBI | Jan-Mar 2013; 4(1): 58–60
Globalization of clinical research introduced several new challenges to the major stakeholders. These emerging aspects are dealt by regulators by providing and updating guidelines, making recommendations, formulating and amending laws to safeguard the trial participant and assure the ethical conduct of clinical research. These issues do not end with the completion of the clinical trial as, the researchers and sponsors are facing another challenge of providing post-trial access (PTA) to the trial participants. There are several difficult questions for the health law and policy makers regarding providing access to investigational new drug. The first question raised in this regard is the legal or ethical validity of claim for post trial access, and other debatable aspects like giving priority over others, its description in consent process, and who will bear the responsibility associated with the access after the completion of trial. We require a firm consensus from all the stakeholders on best way to respond to such access demands. The Legislation and guidelines are inconsistent, ambiguous or silent about many of these aspects. The post-trial access is one of the issues which is still not been precisely analyzed and several aspect of it remain inconclusive. This article tries discussing the ethical issues, regulatory guidelines and perspective of major stakeholders on post trial access of the trial drug.