Open Access News

News from the open access movement

Thursday, June 19, 2008

Comment periods on clinical trial data

There are currently two opportunities for the public to comment on registries for the results of clinical trials. (Thanks to Emma Veitch.)
  • The World Health Organization is conducting a public consultation for feedback on the proposal that "the findings of all clinical trials must be made publicly available". Background information is available from an article published in the Bulletin in April 2008. The survey will be open to responses until midnight (Geneva time) on July 4, 2008. From the article:
    ... The next step [beyond registration of clinical trials] to informed decision-making is to make the findings of clinical trials available, since it is knowledge of the findings, rather than of the existence of a trial, that is likely to have the greatest impact on people trying to choose between alternative interventions. The arrival and growth of electronic publishing and the Internet as dissemination tools without page or length restrictions has greatly expanded the ability of people to make findings available and accessible in full. The recognition of the need for reliable evidence to improve healthcare and to facilitate the synthesis of the results of research into systematic reviews has fuelled the demand for access to the findings of all research, as have the needs of the numerous other stakeholders in clinical research.

    The position proposed by the members of the WHO Registry Platform Working Group on the Reporting of Findings of Clinical Trials is that "the findings of all clinical trials must be made publicly available". ... Our goal is to contribute to the ongoing debate and to foster the collaboration that is necessary to ensure that the findings of clinical trials do not remain hidden from the people who need access to them. ...

    Historically, access to the results of a trial has usually been achieved through publication in a peer-reviewed journal. This traditional publication model has its limitations, particularly in an environment where the end users of research information now include healthcare policy-makers, consumers, regulators and legislators who want rapid access to high quality information in a “user-friendly” format. In future, researchers may be legally required to make their findings publicly available within a specific timeframe (assuming any legislation created does not have escape clauses built in). In the United States of America, such legislation is already in place. This may compromise the ability of researchers to publish trial findings in a peer-reviewed journal. Although some journal editors have acknowledged the changing climate around results registration and reporting, they may have a conflict of interest in that they will probably want the key (and potentially most exciting) messages from a trial to appear first, and perhaps exclusively, in their publication. ...
  • The implementation of the U.S. legislation referenced above is now being planned. Section 801 of Public Law 110-85 (the Food and Drug Administration Amendments Act of 2007) requires that clinical trials for any drugs, biologics, and medical devices subject to FDA regulation must be registered at The bill also lays out certain information that must be submitted about these trials, that this information must be available to the public over the Internet through a database administered by the NIH, and certain conditions on how the information must be available. It doesn't require depositing the raw data of the trial's results, nor of publications resulting from the trial; i.e., the bill requires OA to certain information about the trial, but not OA to the complete trial data nor OA to publications resulting. A mockup of the data entry interface for the database is now available. The deadline to comment on the mockup is July 9, 2008.
Comment. As Peter points out, this is call for public comments: an occasion for people to call for OA to the trial data themselves. It's also noteworthy how the rhetoric for public disclosure of trial results parallels the arguments for OA.