Clinical Trial Registries: An Industry Perspective

Abstract

In recent years an explosion has occurred in the disclosure of clinical trial information through clinical trial registries, partly driven by legislative demands and the requirement by a group of pharmaceutical journals for increased transparency. As a consequence, a large amount of information is now available to the general public and health care providers. In complying with the disclosure requirements, different pharmaceutical companies have chosen different approaches in providing clinical trial information. We conducted a survey among a sample of pharmaceutical companies of varying size to determine their views on the current situation, the challenges they face, and the future of the clinical trial disclosure initiative.

Key learnings were that, in their view, transparency has improved substantially, but more so for the scientific community than for the patient. Patient awareness is thought to be relatively low. The increasing demands of legislation cause challenges for companies both in interpretation and in resource requirements, and it was thought this may cause the industry and the whole initiative to lose sight of the original aim, which was to improve transparency for the general public and the patient. Particular challenges mentioned include the new requirements for clinical trial data disclosure and the provision of lay summaries, the proliferation of registries with the associated potential confusion for patients, and the increasing complexity of legislation. Overall, survey respondents concluded that while much has been achieved, more remains to be done, and that patient needs should take priority.