FDAAA: Push to open data in clinical medicine

In 2005 registration of clinical trials in publicly available databases before the first patient was entered became mandatory for papers submitted to the most important medical journals. In September of last year, U.S. President Bush signed the Federal Drug Administration Amendment Act (FDAAA) into law. Starting September 2008, all clinical trials registered in the clinicaltrials.gov database (with the exception of phase I trials) have to report key results of the main outcomes no later than 12 months after data for the last subject were received.

This required reporting of results has so far largely gone unnoticed in the medical community, but will dramatically change the way research involving patients is conducted and reported. The 12 month deadline will probably lead to earlier reporting of many trial results, and not publishing negative results will be much more difficult. The required reporting in a standardized format will also facilitate the meta-analysis of several similar trials.

Reporting of trial results in this format will not be considered previous publication by member journals of The Internal Committee of Medical Journal Editors (ICMJE).

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7 Responses to FDAAA: Push to open data in clinical medicine

  1. Bob O'Hara says:

    Indeed, thanks. Any idea how much will this affect non-US clinical trials? Even if there isn’t a formal effect, I guess it might have the effect of increasing social pressure to follow these rules.

  2. Martin Fenner says:

    Almost all trials with new drugs (and devices) by pharmaceutical companies, including non-US trials, ultimately seek FDA approval, so this is very important. And the move to clinical trial registration and reporting is supported by many other groups and organisations, including the “WHO”:http://www.who.int/ictrp/results/consultation/en/index.html.

  3. Graham Steel says:

    I feel a blog post coming on.

  4. Graham Steel says:

    And “here it is”:http://mcblawg.blogspot.com/2008/08/open-data-in-clinical-medicine.html
    Thanks for the inspiration Martin.
    SynchroBlogging? Not really here but IMHO, this is definitely something that us bloggers should do more often.

  5. Martin Fenner says:

    Graham,
    clinical trial registration and reporting is something I care much about for a variety of reasons. Here is some further reading:
    * “Clinical Trial Registration: The Differing Views of Industry, the WHO, and the Ottawa Group”:http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020378 _PLoS Med_ 2005;2(11):e378
    * “Issues in the Registration of Clinical Trials”:http://jama.ama-assn.org/cgi/content/abstract/297/19/2112. _JAMA_ 2007;297:2112-2120.
    * “Opinions on registering trial details: a survey of academic researchers”:http://www.biomedcentral.com/1472-6963/8/18 _BMC Health Services Research_ 2008;8:18
    * “Helping editors, peer reviewers and authors improve the clarity, completeness and transparency of reporting health research”:http://www.biomedcentral.com/1741-7015/6/13 _BMC Medicine_ 2008;6:13

  6. Graham Steel says:

    In light of your comment, you will no doubt be aware of the TRIPS Agreement.
    Midway through reading these links reminded me of “Monopolizing Clinical Trial Data: Implications and Trends”:http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0040002 _PLoS Med_ 2007;4(2): e2
    After I read that one, I contacted the author and had an enjoyable and fruitful dialogue with her. The gist of what I said to her was:-
    _May I be one of many to send their congratulations to you on the publication of your extremely important and far reaching PLoS Essay._
    _I sincerely hope this Essay is widely disseminated. I for one will certainly be doing this and can think of a large number of my contacts who will be more than interested to read it._
    _My sincere thanks._
    _Warm Regards_
    I can also openly reveal for the first time that Peter Murray-Rust and I are mid way through preparing our own Manuscript in this genre at the bequest of the ed-in-chief of an excellent BMC Journal. Ours is part of a related set of Manuscripts including “a recent one”:http://www.peh-med.com/content/2/1/31 by Prof Stevan Harnad. It’s an honour and a privilege for a layman like myself to collaborating with the likes of Stevan and Peter and indeed our Ed Michael at the PEHM.
    If ours passes peer review and is accepted for publication, something that I care much about _(and devoted 5 years of my life to)_ for a variety of reasons will finally be free to read by anyone interested. Peter’s input will also make this more broadly subjective in nature.