Trial Registration and Public Access to Data

Clinical trial registration is an important component of clinical trial administration and provides a variety of benefits to investigators, participants, potential participants, referring physicians, institutional review boards (IRBs), journal editors, and the medical community at large. Trial registration has been mandated by several national and international authorities, including the Food and Drug Administration (FDA), World Health Organization (WHO), and International Committee of Medical Journal Editors. This chapter discusses specific issues related to clinical trial registration including responsible parties, timeliness of registration, and reporting of data. We briefly present issues associated with public access to data such as privacy rights, intellectual property issues, and legitimization of non-peer-reviewed results.