Posttrial Access to Medical Interventions: Intricacies, Challenges, and Solutions

Abstract

With the recent increase in clinical trials, lower- and middle-income countries are preferred trial sites due to lower budgets and easy availability of potential participants. On trial completion, benefits to participants cease and it may affect their health adversely. Therefore, entitlement to posttrial access (PTA) of interventions is imperative. The Declaration of Helsinki and several other guidelines mandate that trial participants have access to experimentally proven efficacious drugs and that the research protocol should mention PTA provision mechanisms. A controversial question about PTA is whether, experimentally proven therapy should be made accessible to the control group as well as the community from which the participants were enrolled, especially if no satisfactory standard treatment exists. PTA has significant implications for various stakeholders - trial participants, investigators, sponsors, regulatory authorities, and governments and has been discussed and well addressed in recent guidelines issued by the Indian Council of Medical research. This article focuses on the PTA, guidelines related to PTA, disputes, different stakeholder perspectives, and practical difficulties in its implementation. It also looks at PTA from the Indian perspective and considers possible solutions to deal with the controversies.

Keywords: Clinical research; Declaration of Helsinki; clinical trial; ethics; posttrial access.