Tuesday, July 1, 2008

NIH Asks How to Create a More Effective Clinical Trials System

The National Institutes of Health recently held a town hall meeting to brief patient advocacy groups and other external constituencies about its initiative to remove barriers to more efficient conduct of clinical trials at the Clinical Center on the NIH campus. The Clinical Center is really a national jewel, the largest hospital in the world dedicated exclusively to research (and therefore a major sponsor of clinical trials). It has almost 2000 active protocols in which tens of thousands of patients participate with the goal of advancing our understanding of disease and, one hopes, developing more effective treatments.

But even though the Clinical Center has spectacular resources compared to many clinical trials sites around the country -- starting with its beautiful new building and state-of-the-art lab space in Bethesda -- it experiences all the same frustrations with the process as everyone else. Regulatory burdens increasing. Inconsistent policies and practices among Institutional Review Boards -- even within NIH there is no uniformity, and different Institutes and Centers handle things differently! Flat research funding. Declining numbers of clinical researchers. It hopes through its study of the problems on its own campus to inform the debate outside its walls, in the extramural research community. The goal of the NIH's review is to share best practices in conducting trials across the institutes and centers within NIH, and to identify over-interpretation of applicable regulations. Officials who spoke at the event seemed confident that many of the barriers were not externally imposed but were rather due to differing interpretations of regulations and the sheer volume of changing requirements, with which everyone finds it hard to keep up.

The NIH's Intramural Research Program -- the research conducted on its campus by NIH-employed scientists -- of which the Clinical Center is a part, is a little recognized critical resource in our taxpayer-funded research portfolio. At its best it provides a model of cutting-edge biomedical research for the extramural, mostly academic research world, taking on the highest-impact science and suggesting solutions to systemic challenges. We hope that this effort to plow through the thicket of complaints and paperwork that surround clinical research and clinical trials will be such a model for the rest of us.

-- Kristin Schneeman, Program Director, FasterCures

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