Mandatory Clinical Trial Registration: Rebuilding Public Trust in Medical Research

Abstract:     
In 2006, a working group of the World Health Organization recommended the establishment of a mandatory clinical trials registry for all research involving humans. Clinical trials registration prior to subject recruitment is required by many major medical journals, and several national regulators either introduced registration requirements or are considering doing so. While the principle of trial registration has been widely endorsed, including by the pharmaceutical industry, its content and modus operandi has been the subject of debate. Industry has claimed that registration of some of WHO's required registration elements could impact negatively on intellectual property rights and undermine the competitive advantage of pharmaceutical innovators. This chapter discusses first what the WHO clinical trials registration initiative proposes. It then provides an overview of the ethical and public policy reasons behind clinical trials registration. These provide the background from which to analyze the arguments that have been invoked in favour of limiting some aspects of trial registration. Clinical trials registration should not be seen as a potential threat for intellectual property rights over pharmaceutical products. In addition, the interest in gaining a competitive advantage cannot outweigh the public interest in registration of clinical trials. Registration of trials will, however, not be sufficient to solve some of the significant problems associated with industry's control over the design, conduct, analysis, and reporting of results. The chapter ends with an endorsement of the need for further regulatory initiatives.

Number of Pages in PDF File: 7

Keywords: Clinical trials, clinical trials registration, medical research, results reporting, pharmaceuticals, scientific integrity, intellectual property, patents, competitive advantage, disclosure, research subjects

JEL Classification: I1, K2, K32, L5

Accepted Paper Series