Intended for healthcare professionals


Mandatory disclosure of trial results for drugs and devices

BMJ 2008; 336 doi: (Published 24 January 2008) Cite this as: BMJ 2008;336:170
  1. Trish Groves, deputy editor
  1. 1BMJ, London WC1H 9JR

    New US law will require public posting of all the main results and data on harms

    Last week the drug industry was shown, twice, to have suppressed trial results that were commercially unfavourable—an all too familiar tale.1 2 But from September 2008, a new US law will mandate the public disclosure of such results, and it will no longer be left to investigative journalists and other researchers to dig out the findings of trials.

    The FDA Amendments Act, passed quietly last year, rules that any ongoing clinical trial involving a drug, biological product, or device regulated by the US Food and Drug Administration (FDA) must be registered at and that, from 27 September 2008, triallists must start to post in that same registry the results of those trials.3 This applies to all clinical trials of drugs and devices except phase I drug trials (preliminary safety studies for new products) and small feasibility studies of a device. Furthermore, it covers all …

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