Pharmaceutical industry makes commitment to submit clinical trial results for publication
Medicines Australia fully supports a new commitment by the global research-based pharmaceutical industry to submit for scientific journal publication the results of all its Phase III clinical trials.
The commitment, set out in a policy position announced last week by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), requires member companies to submit for publication in a peer-reviewed journal the results of all their industry-sponsored Phase III trials, irrespective of whether the outcome of the trial was positive or negative.
Medicines Australia chief executive Dr Brendan Shaw said the new commitment would bring an extra dimension of transparency to clinical research.
“Transparency and openness are critical in ensuring the pharmaceutical industry maintains the trust of the community,” Dr Shaw said.
“Medicines Australia members and other members of the IFPMA already disclose the clinical trials they are undertaking in online registries. This new policy position commits to a further level of transparency.”
Submission of manuscripts should occur ideally within 12 months and no more than 18 months after approval of the product concerned or any decision to discontinue a trial.
The policy also sets out guidelines to enhance the transparency regarding authorship of manuscripts. Company involvement in both the research and the publication should be disclosed and sponsors should encourage authors to disclose all relevant interests.
“Changing community expectations are demanding greater openness and transparency in clinical research,” Dr Shaw said.
“The publication of clinical trial manuscripts in peer-reviewed journals and the full disclosure of authorship recognises those expectations.”
The Joint Industry Position on the Publication of Clinical Trial Results in the Scientific Literature is available at:
http://www.ifpma.org/fileadmin/webnews/2010/pdfs/20100610_Joint_Position_Publication_10Jun2010.pdf
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