Gender Issues in Clinical Trials: Ethical, Regulatory and Practical Considerations

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical, Patient Recruitment & Retention,
  • Monday, October 07, 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.



Dr. Gordon DuVal, SJD, Principal, Gordon DuVal Consulting

Gordon DuVal is a lawyer who has spent the past 20 years working in biomedical ethics and health law. He is now a consultant focusing on ethical, legal and regulatory issues in health care and research. He has a doctorate in law (SJD) and currently teaches health law and medical ethics at the University of Ottawa Faculty of Law and serves as Chair of the National Research Council of Canada Research Ethics Board (IRB).

Dr. DuVal has been a member of the University of Toronto’s Joint Centre for Bioethics and its Faculties of Medicine and Law. He was also the bioethicist and research ethics adviser to a large psychiatric hospital and research centre in Toronto. He also worked at the NIH Department of Bioethics and as a Fellow at the University of Chicago MacLean Center for Clinical Medical Ethics. He practised law for a number of years prior to taking up an academic career.

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Dr. Agnes Klein, MD, MPH, Director, Centre for the Evaluation of RadioPharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate, Health Canada

Agnes V. Klein MD, DPH, is currently the Director, Centre for the Evaluation of RadioPharmaceuticals and Biotherapeutic Products in the Biologics and Genetic Therapies Directorate.

After receiving her medical degree from the University of Toronto, Dr. Klein trained in Endocrinology, Medical Biochemistry and Public and Community Health. Subsequently, after joining Health Canada, she has occupied many and varied scientific and management positions with Health Canada. Amongst relevant accomplishments, Dr. Klein represented Health Canada on NCBHR, as founding member and on NCEHR as well as chairing the Committee on Clinical Trials of the Council. In 2000, Dr. Klein moved from the Drugs side of the regulatory Directorates to Biologics and was at the forefront of many of the changes that shaped the current Biologics and Genetic Therapies Directorate.

Dr. Klein’s special interests include the appropriate design of clinical trials and the various and complex ethical issues attendant to the design and conduct of clinical trials and other studies in human subjects. Dr. Klein was a member of Health Canada’s Research Ethics Board, and continues her involvement with that REB as a senior advisor. She is an active member of several medical and scientific organizations nationally and internationally.

Dr. Klein has also supervised several graduate students under various student programmes related to Health Canada, especially under the graduate Masters’ and PhD candidates at the Université de Montréal. She has also been part of the Departmental mentoring programme: several of her mentees attained senior management and strategic positions. Dr. Klein has also hosted and supervised Health Sciences Management Development candidates who were then successful in developing their policy and strategic acumen.

Dr. Klein has multiple interests and was instrumental in championing the first Paediatrics Guidelines of any regulatory agency, as well as the first Guidelines for the inclusion of Women in Clinical Trials, and now the new Guidelines for the Inclusion of Women in Clinical Trials, as far back as 1995.

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Mr. Zach Hallinan, Director of Patient Communication and Engagement Programs, Center for Information and Study on Clinical Research Participation

Zach Hallinan is the Director of Patient Communication and Engagement Programs at the non-profit Center for Information and Study on Clinical Research Participation (CISCRP). A graduate of the University of Pennsylvania, he oversees CISCRP’s programs for better understanding and meeting the needs of clinical research volunteers globally. He has been recognized for his work and scholarship by the American Chemical Society and the National Science Foundation, and was recognized by CenterWatch as one of 20 innovators changing the face of the clinical trials industry.

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Who Should Attend?

Senior Researchers, Investigators, IRB Administrators, and individuals responsible for research performance and oversight at research sponsors, organizers, CROs and SMOs.

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