FDA rules that researchers will have to disclose financial interest

BMJ 1998; 316 doi: (Published 14 February 1998) Cite this as: BMJ 1998;316:493
  1. Deborah Josefson
  1. San Francisco

    Drug companies submitting licensing applications to the Food and Drug Administration (FDA) in the United States will now have to reveal whether researchers involved in a drug trial have any financial interest in the company. The new regulations aim to eliminate possible data bias arising from financial considerations.

    Effective from February 1999, the new rules will require companies to disclose whether clinical investigators have received stock and patent options, payments in the form of research grants, gifts of equipment, consultant fees, and honorariums from lectures.

    Drug companies routinely recruit doctors and scientists to study their products and to conduct clinical …

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