The research-based pharmaceutical industry has announced principles of disclosure of clinical trial information through clinical trial registries and databases. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has jointly developed these principles 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 Data bases 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. Beginning mid-2005, the industry will make the results public of trials that have taken place - both positive or negative - together with information on those that are just being initiated. This includes all trials except exploratory trials, where results will be published only if they have significant medical importance.
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 completion.
Reference: IFPMA website at http://www.ifpma.org/News/