Ethical Considerations in Industry-Sponsored Multiregional Clinical Trials
Pharmaceutical statistics 2010 Jul; 9(3): 230-41
During the last several decades, the scientific and ethics communities have addressed important ethical issues in medical research, resulting in the elaboration and adoption of concepts, guidelines, and codes. Ethical issues in the conduct of Multiregional Clinical Trials have attracted significant attention mainly in the last two decades. With the globalization of clinical research and the rapid expansion to countries with a limited tradition of biomedical research, sponsors must proactively address local ethical issues, the adequacy of oversight as well as the applicability and validity of data, and scientific conclusions drawn from diverse patient populations. This paper highlights some core ethical principles and milestones in medical research, and, from an industry perspective, it discusses ethical issues that the clinical trial team may face when conducting Multiregional Clinical Trials (MRCT, clinical trials conducted at sites located across multiple geographic regions of the world). This paper further highlights the areas of consensus and controversies and proposes points to consider.
Showing items related by title, author, creator and subject.
Improving Academic Leadership and Oversight in Large Industry-Sponsored Clinical Trials: The ARO-CRO Model Goldenberg, Neil A; Spyropoulos, Alex C; Halperin, Jonathan L; Kessler, Craig M; Schulman, Sam; Turpie, Alexander G G; Skene, Allan M; Cutler, Neal R; Hiatt, William R (Antithrombotic Trials Leadership and Steering Group, 2011-02-17)Standards for clinical trial design, execution, and publication have increased in recent years. However, the current structure for interaction among the pharmaceutical sponsor funding a drug or device development program, ...
Pyke, Stephen; Julious, Steven A; Day, Simon; O'Kelly, Michael; Todd, Susan; Matcham, James; Seldrup, Jorgen (2011-01)Concerns about potentially misleading reporting of pharmaceutical industry research have surfaced many times. The potential for duality (and thereby conflict) of interest is only too clear when you consider the sums of ...
Proposed Best Practice for Statisticians in the Reporting and Publication of Pharmaceutical Industry-Sponsored Clinical Trials Matcham, James; Julious, Steven; Pyke, Stephen; O'Kelly, Michael; Todd, Susan; Seldrup, Jorgen; Day, Simon (2011-01)In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry-sponsored clinical trials. We make eight recommendations covering: author responsibilities ...