OmniScience archive> IFPMA Guideline

  • New guideline on Clinical Trial Data publication and author transparency issued by the drug industry representative body (IFPMA)

    On 10 June 2010, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) adopted a new voluntary guideline that was approved by the pharmaceutical industry representative bodies of Europe, Japan and USA.

    The position paper,Joint Industry Position on the Publication of Clinical Trial Results in the Scientific Literature commits their members and associates, as a minimum, to submit for publication as an article in a peer-reviewed journal, the results of all their industry-sponsored phase III clinical trials, as well as the results of other trials of significant medical importance, whether positive or negative.

    It states that, ideally, manuscript submission should occur within 12 months, and no more than 18 months, after product approval or the decision to discontinue the trial.

    For trials of already marketed products, manuscript submission should be within 12 months of the completion of the trial and not more than 18 months after that date. This paper goes beyond the organisation's previous guideline calling for publication of trial data in summary form at on-line clinical trial registries. Online registration details and summary results of members' clinical trials can be located easily, using the IFPMA Clinical Trials Portal.

    The paper also provides guidelines on the criteria for manuscript authorship and acknowledgement of other contributors such as statisticians and medical writers.

2015 OmniScience SA. All rights reserved.