Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions,: A Conference
On January 19 - 21, 2015, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center convened an international panel of experts at the Brocher Foundation in Switzerland for a closed workshop entitled “Clinical Trial Recruitment: Problems, Misconceptions, and Possible Solutions.” The Brocher Foundation offers competitive workshop grants on topics related to the ethical, legal and social implications of the development of medical research and biotechnologies.
This workshop brought together investigators, patients, ethicists, lawyers, physicians, regulators, representatives from industry, and heads of the international organizations behind leading statements of research ethics, including the World Medical Association (WMA) and the Council for International Organizations of Medical Sciences (CIOMS), for three days focused on understanding whether there are barriers to clinical trial recruitment that could and should be overcome. Topics covered included:
Determining as a foundational matter if a recruitment problem exists in clinical research, and if so, its scope and context;
Assessing cultural and legal differences related to acceptable recruitment practices, and the underlying principles behind these differences;
Analyzing approaches to potentially reduce the need for new clinical research participants (such as innovative trial designs and sharing of clinical data);
Evaluating the ethical issues raised by and feasibility of strategies for increasing enrollment in trials (such as building in more patient participation in research design, recruiting through social media, opportunities for results return and post-trial access for therapeutics, compensation for injuries, and financial and non-financial incentives for participation).
Having developed a research agenda for this space, the workshop will generate academic publications, practical tools for investigators and Institutional Review Boards/Research Ethics Committees, empirical research projects, and other outputs. Key themes emerging from the workshop were the need to actively engage patients as partners in the research endeavor from the very beginning, and encouragement to respond to the shortage of research participants that exists in some contexts by prioritizing the most important trials and exploring innovative trial designs.
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For additional information, please contact Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, firstname.lastname@example.org.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is a research program founded in 2005 to promote interdisciplinary analysis in these fields. The Center is dedicated to the unbiased analysis of pressing questions facing health policymakers, medical professionals, patients, families, and others who influence and are influenced by health care and the health care system.
Established in 2008, Harvard Catalyst | The Harvard Clinical and Translational Science Center is dedicated to improving human health by enabling collaboration and providing tools, training, and technologies to clinical and translational investigators. As a shared enterprise of Harvard University, Harvard Catalyst resources are made freely available to all Harvard faculty and trainees, regardless of institutional affiliation or academic degree.
The Brocher Foundation, located in Hermance, Switzerland, hosts experts in the ethical, legal, and social implications of the development of medical research and biotechnologies. Its hosts scholars in residence, workshops and symposia, and summer academies.bioethics biotechnology clinical research health law policy human subjects research innovation intellectual property international pharmaceuticals