Abstract

The urgency of a change in the nature of clinical trial practice is underscored by the number and severity of recent controversies involving non-disclosure of clinical trial data and the resulting harm to patients and the practice of medical research. Corporate malfeasance of this nature arises to some extent from the tension inherent in the current legal and regulatory regimes governing medical research regarding various types of government-sponsored financial interests associated with medical research and product development which allow for a significant degree of self-policing. The WHO recently put into practice policy requiring pharmaceutical sponsors to mandatorily register all clinical trials on a global basis with a public registration system. Mandatory registration is based on the presumption that transparency in medical research is of crucial importance to the public generally and for research subjects who volunteer their time to participate in clinical trials under conditions of risk. In light of this risk profile, the WHO has stated that mandatory registration is a scientific, ethical and moral responsibility for all interested parties. As such, it represents an important step in promoting transparency and accountability of the medical research enterprise as well as for national governments in their increasing efforts to partner with industry to foster global competitiveness.