Improving the State of the Clinical Research Enterprise

The burgeoning regulatory burden of doing clinical research in the United States increasingly impacts the ability of companies and individual researchers to perform sound, expeditious clinical studies.  While all clinical scientists are affected by the seemingly endless regulatory requirements, pediatric researchers and those engaged in multisite trials are especially hard-hit as a result of additional layers of regulation for research involving children and inconsistent IRB interpretation of regulations among sites, respectively.

To address specific issues that negatively impact clinical research and to provide recommendations to effect change, The Endocrine Society and Lawson Wilkins Pediatric Endocrine Society (LWPES) are co-hosting a consensus conference in Bethesda, MD, November 5-6, 2008.  The objective of the conference is to identify strategies to facilitate the approval of clinical investigation.  The goals are to develop and publish a set of consensus-based policy recommendations for overcoming regulatory obstacles to patient-oriented research and to identify important areas of regulatory policy that require future study and debate.

The proceedings and recommendations will be submitted for publication, and The Endocrine Society will use the recommendations as the basis for future advocacy efforts with federal agencies and Congress to address clinical research regulatory burden.

To achieve the goals and to generate broad support for the recommendations, all major stakeholder groups will be represented at the workshop, including government agencies (NIH, OHRP, FDA), academia, the pharmaceutical industry, and patient advocate groups.  To ensure focused and balanced discussion, attendance and participation are by invitation only.

The program has been developed by a Steering Committee co-chaired by The Endocrine Society's Vice President, Clinical Science Lynnette K. Nieman and LWPES' Past-President Robert L. Rosenfield.  The agenda is in the final stages of development and will include prominent members of the clinical research community addressing such topics as:

• Risk-benefit analyses related to human subjects research, including a historical perspective; institutional risks such as review and approval of COI, utilization and budget; and economic issues

• Issues and models related to multisite projects, including perspectives from the CTSA, NCI central IRB, and VA models; FDA guidance; and OHRP

• Issues specific to investigators doing research in children, including problems in the study of healthy childhood controls and proposed solutions (the CFR 46.407 and 50.54 process, to cover minimal risk definition, IRB considerations, and the OHRP perspective) and defining a "condition" (CFR 46.406 and 50.53 issues, to include discussions on healthy/at risk as a condition and assent of child volunteers)

Co-sponsorship and funding has been sought from a number of pharmaceutical companies and from professional societies with a stake in clinical research.  At the time of writing, the co-sponsor/funder list includes:

American Society of Clinical Oncology
Infectious Diseases Society of America
Juvenile Diabetes Research Foundation

Genentech
Novo Nordisk Inc.
Pfizer, Inc.
Wyeth Pharmaceuticals

Industry Supporter:
Gate

Co-sponsors and funders are invited to send two representatives to the conference, who will not only participate in discussions but also review the draft report as it is being prepared.

The Endocrine Society is dedicated to improving the state of the U.S. clinical research enterprise.  By generating consensus among the major stakeholders on best practices and by advocating for the implementation of policy to effect change, the Society will continue its ongoing efforts to ease the regulatory burden on its clinical research members.