Industry Commits to Submit for Scientific Journal Publication the Results of all its Phase III Clinical Trials
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today approved a “Joint Industry Position on the Publication of Clinical Trial Results in the Scientific Literature” 1 , previously approved by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
Through the Position, the above associations and their member companies and associations commit, as a minimum, to submit for publication as a manuscript 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. The new Joint Position requires submission for publication of the results of all trials within its scope, regardless of whether the outcome was positive or negative.
Mr. Haruo Naito, President of the IFPMA and President and CEO of Eisai, said: “Our earlier Joint Position on Disclosure of Clinical Trials 2 already requires members to disclose the trials they are undertaking and to publish summary results in online registries. This new Joint Position on publication is a logical extension of that approach, requiring members to seek scientific journal publication of the results of the specified trials.”
Submission of manuscripts should occur ideally within 12 months and no more than 18 months after approval of the product concerned or the decision to discontinue the trial. In the case of trials of a product which is already marketed, submission should ideally be within 12 months of the completion of the trial and not more than 18 months after that date.
The Position also lays down guidelines which enhance transparency regarding the authorship of manuscripts. An authorship credit requires a substantial contribution to the design of the trial, data acquisition or interpretation, plus drafting or revision of the text, plus final approval. The roles of medical writers, statisticians and other who contribute to a manuscript but who do not meet the authorship criteria should be mentioned appropriately. Company involvement in both the research and publication should be disclosed, and sponsors should encourage authors to disclose all relevant interests. The primary publication for a particular trial should provide an accurate report of its findings, including adverse events, and there should be a discussion of the strengths and limitations of the study.
Geneva, 10 June 2010
1IFPMA, EFPIA, JPMA & PhRMA Joint Industry Position on the Publication of Clinical Trial Results in the
Scientific Literature, 10 June 2010
2IFPMA, EFPIA, JPMA & PhRMA Joint Position on the Disclosure of Clinical Trial Information via Clinical
Trial Registries and Databases, 10 November 2009