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FDA seeks to ease burden on trial review boards

BMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7494.748-a (Published 31 March 2005) Cite this as: BMJ 2005;330:748
  1. Bob Roehr
  1. Washington, DC

    The growth in the number and complexity of clinical trials has put great strain on institutional review boards in the United States, say experts in evidence submitted to the US Food and Drug Administration.

    The boards were set up to approve and review biomedical research using humans. But the pressures on them, due in part to the large number of sites in trials, are growing to such an extent that a new approach is needed, in particular to recording adverse events, the FDA was told at a public hearing at its headquarters on 21 March.

    The meeting was held to find out how the process might be improved to best meet the primary purpose …

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