Download this Paper Open PDF in Browser

Mandatory Clinical Trial Registration: Rebuilding Public Trust in Medical Research

GLOBAL FORUM UPDATE ON RESEARCH FOR HEALTH, Vol. 4: Equitable Access: Research Challenges for Health in Developing Countries, pp. 40-46, London: Pro-Book Publishing, 2007

7 Pages Posted: 14 Jan 2008 Last revised: 17 Feb 2014

Trudo Lemmens

University of Toronto - Faculty of Law

Ron Bouchard

University of Manitoba - Faculty of Law (deceased)

Date Written: 2007

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.

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

Suggested Citation

Lemmens, Trudo and Bouchard, Ron, Mandatory Clinical Trial Registration: Rebuilding Public Trust in Medical Research (2007). GLOBAL FORUM UPDATE ON RESEARCH FOR HEALTH, Vol. 4: Equitable Access: Research Challenges for Health in Developing Countries, pp. 40-46, London: Pro-Book Publishing, 2007. Available at SSRN: https://ssrn.com/abstract=1083565

Trudo Lemmens (Contact Author)

University of Toronto - Faculty of Law ( email )

78 and 84 Queen's Park
Toronto, Ontario M5S 2C5
Canada

Ron Bouchard

University of Manitoba - Faculty of Law (deceased)

Paper statistics

Downloads
229
Rank
114,568
Abstract Views
1,735