Operational Issues in Clinical Trial Disclosure of Global Trials

Abstract

In hospitals and clinics around the world, ordinary people place their health and their very lives in the hands of researchers who test new experimental drugs for safety and effectiveness. The public and legislators worldwide have expressed increasing interest in understanding how clinical trials are conducted and the results of those trials. The list of stakeholders has grown substantially in recent years to include medical and scientific academia, government agencies, regulatory authorities, and advocacy groups. Quite logically, stakeholders’ interests have shifted slightly from the registration of clinical trial protocol information to the posting of clinical trial results upon trial completion. Protocol registration and results reporting requirements are staggering, diverse, and complex. This article provides a look at industry experience with the operational challenges of clinical trial registries and results databases that the pharmaceutical, medical device, and biotechnology industry, and academia face when providing clinical trial information.