Toronto, Canada (PRWEB) September 30, 2013
Meeting subject recruitment targets in clinical trials in this “hurry-up” era of global competitive clinical trial enrolment is already a major challenge for sponsors and researchers. At the same time, fuller understanding of the genetic, metabolic and physiologic differences between genders is crucial to the development of safer and more effective drugs and medical devices for both men and women. These two imperatives are not mutually exclusive.
FDA, ICH, and most recently Health Canada, have all issued guidance to encourage, if not actually require, sponsors to include more women in clinical trials. IRBs are both ethically and legally bound to ensure that subject selection is equitable, and that both men and women are represented.
Yet, despite the ethical necessity and regulatory encouragement, most available evidence shows there still are significant gender inequalities in clinical trial participation – women continue to be underrepresented, and equitable participation of both sexes remains an elusive yet necessary goal.
Dr. Gordon DuVal will briefly discuss the principle of distributive justice, the ethical requirements for equitable subject selection, specifically as applied to women in research. Dr. Agnes Klein will discuss the issues from Health Canada’s perspective as the regulatory agency with the most recent and perhaps most progressive guidance in the world on the inclusion of women in clinical trials. CISCRP’s Mr. Zach Hallinan will offer specific insights into the practical barriers to overcome, and some strategies that can be successfully employed by sponsors and sites to encourage better engagement and improved recruitment and retention of women in clinical trials, a legal, moral and pragmatic imperative.
Mr. Jack Corman, President and Founder of IRB Services (Institutional Review Board Services), will join the panel for a live Q&A with
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