The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has jointly developed these principles of disclosure together with three other industry associations: the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufactures Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
The joint position on the disclosure of clinical trial information via clinical trial registries and databases demonstrates the innovative pharmaceutical industry’s commitment to increasing the transparency of clinical trials sponsored by their member companies.
“The industry recognizes that there are important public health benefits, including increased confidence, associated with making clinical trial information more widely available to healthcare practitioners, patients and others”, said Dr Harvey Bale, director general of IFPMA.
Under the proposals, drawn up by the world’s major pharmaceutical industry trade associations and agreed by major companies, summary results of industry-sponsored clinical trials on a medicine that has been approved for marketing will be publicly disclosed via free, publicly accessible databases, regardless of outcome.
Details of ongoing clinical trials being performed to determine a medicine’s therapeutic benefit will also be publicly registered at initiation so that patients and clinicians will have information about how to enrol. Both requirements will be adopted by the worldwide pharmaceutical industry during 2005.
Trial results will be published in a standard, non-promotional summary that will include a description of trial design and methodology, results of primary and secondary outcome measures described in the protocol, and safety results. If the results are published in a peer-reviewed medical journal, the database will include a link to the relevant article
The results will be published within one year after the medicine is approved or, for post-approval trials, within one year of them being completed.