Public access to clinical trials: Lessons from an organizational implementation of policy.

Efforts to make clinical trials and their results more publicly available have been increasing in recent years. However, there is a need to better understand ways to achieve these goals aimed at benefiting a diverse set of stakeholders. Since 2005, the U.S. Department of Veterans Affairs Office of Research and Development (ORD), part of the nation's largest integrated health care system, has required the clinical trials its funds to be registered in ClinicalTrials.gov as a condition of the award. Furthermore, summary results of studies active since 2007 have been included in the registry. This paper highlights ORD activities, challenges and lessons at investigator, study, and organizational levels. Key factors in ORD's approach include: a mission-oriented approach; leadership support; a working group for organizational policies and practices; prioritizing communication; and recognizing the needs of investigators. Making clinical trials available to the public should represent a focal point for groups desiring to maximize the contributions from such research. The ability to do so must involve a commitment by sponsors and a critical evaluation of the reasons, requirements and resources at multiple levels. Published by Elsevier Inc.