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Society Takes Leadership Role in Easing Burden of Clinical Research Regulation
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Endocrine Insider November 13, 2008 Last week, The Endocrine Society undertook a major initiative in support of its clinical researcher members and established itself as a leading organization in the clinical research policy arena when it hosted a workshop titled "Regulation of Clinical Research—Improving the Balance: A Consensus Conference." Clinical researchers face difficulties gaining approval for their research protocols because of inconsistent protocol review by Institutional Review Boards (IRBs) and other regulatory hurdles associated with research involving human subjects. The two day conference, jointly hosted by the Society and Lawson Wilkins Pediatric Endocrine Society (LWPES), focused on regulatory burdens associated with multisite trials and with pediatric research. Lynnette K. Nieman, MD, Vice President-Clinical Science, co-chaired the organizing committee with Robert L. Rosenfield, MD, Past-President of LWPES. The discussion focused on risk-benefit analyses related to human subjects research, issues and models related to multisite projects, problems in the study of healthy childhood controls, and efforts to define a "condition." The conference included presentations by experts in the field, panel discussions, and small group discussions to identify solutions to the problems raised by the panelists. The discussions will inform a consensus paper to be published in a peer-reviewed journal and a set of recommendations to regulatory agencies, members of Congress, IRBs, and institutions to streamline and facilitate human subjects research. The conference brought together prominent members of the clinical research community, including representatives from government, industry, and academia. The inclusive format allowed representatives from government agencies including the Office of Human Research Protections (OHRP) and the US Food and Drug Administration (FDA) to hear first-hand the difficulties faced by investigators as a result of federal regulations and inconsistent interpretation of those regulations. Such understanding among agency staff has laid the groundwork for future discussions with the agencies to work toward policy changes. The conference was co-sponsored by 15 non-profit organizations and pharmaceutical manufacturers, including the American Society for Bone and Mineral Research, American Thyroid Association, and The Obesity Society—all Sister Societies—and the American Society of Clinical Oncology, Astra Zeneca, Bristol-Myers Squibb, Burroughs Wellcome Fund, Infectious Diseases Society of America, Genentech, Gate, Juvenile Diabetes Research Foundation, Novo Nordisk, Pfizer, Pharmaceutical Researchers and Manufacturers of America, and Wyeth. The regulatory burden associated with conducting research on human subjects may be the most limiting factor, besides funding difficulties, in the clinical research process. If a streamlined, standardized set of criteria were to be accepted by all organizations that monitor and support clinical research, researchers would be freed to concentrate on the research rather than the administrative work associated with IRB approval. The Endocrine Society is dedicated to easing the regulatory burden for its clinical researcher members. With consensus recommendations from the recent conference, the Society will have a strong advocacy tool to use in its future efforts in this area.   Lynnette Nieman, MD, Vice President- President Robert M. Carey, MD, MACP, Clinical Science, with co-organizer welcoming the audience on the first day Robert Rosenfield, MD, Past-President of the conference of LWPES   Lynnette Nieman addressing the participants Conference participants
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