R&D-based pharma industry commits to submit all Ph III results for scientific journal publication

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,' 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) and the IFPMA's council (The Pharma Letter November 11, 2009).

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.

Haruo Naito, president of the IFPMA and president and chief executive of Japanese drug major Eisai, said: 'Our earlier Joint Position on Disclosure of Clinical Trials already requires members to disclose the trials they are undertaking and to publish summary results in on-line 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.'