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Pressures at the front lines : investigative sites and contract research organizations in Canadian clinical trials

University of British Columbia

Commercialization of medical research, and clinical trials in particular, has been the subject of scrutiny by policy makers and academics. However, little attention has focused on a more recent but now dominant actor: the contract research organization (CRO). Over the past twenty-five years, CROs have assumed much of academia’s role in the conduct and control of clinical trials, and are now the de facto face of industry sponsors for those working at investigative sites. This dissertation examines sites, their relationship with CROs, and the extent to which Canadians are protected by Canada’s clinical trials oversight framework. This dissertation includes both empirical and normative components. First, and based on an extensive review of industry and academic literature, I describe the lay of the land of clinical trials in Canada and set the regulatory and economic context. Second, a qualitative interview study explores the relatively unexamined interface between site and CRO to identify key areas of concern from the perspective of those working at the frontlines of Canadian clinical trials. This is based on 24 semi-structured interviews. Participants were recruited so as to provide a range of perspectives relevant to the practice realities at the frontlines and the challenges that arise in relation to site-CRO interactions. It includes participants working at sites, CROs, pharmaceutical companies and in consultancy roles with clients across these categories. Third, a critical legal and ethical analysis of the regulatory and policy frameworks governing clinical trials in Canada is undertaken to determine areas of weakness in light of the issues identified in the qualitative study. A number of shortcomings with Canada’s approach to clinical trial oversight in relation to both investigator and industry-initiated trials are identified. Key among these is an overreliance on sponsors for trial oversight, which raises different concerns in industry and investigator-initiated trials. These and other critical issues are explored and recommendations to address such concerns are made. This study supports the growing call for an evidence based approach to protecting human subjects in research and is particularly timely given the intense efforts currently underway to attract more industry funded clinical trials to Canada.

Text

2014-01-17

Attribution-NonCommercial-NoDerivs 2.5 Canada

http://hdl.handle.net/2429/45810

Interdisciplinary Studies

University of British Columbia

UBCV

http://creativecommons.org/licenses/by-nc-nd/2.5/ca/