IFPMA expands scope of mandatory trial disclosure

The Council of the International Federation of Pharmaceutical Manufacturers and Associations has approved an updated version of the IFPMA’s Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases that widens the scope of mandatory disclosure for efficacy studies.

Information submitted to free, publicly accessible clinical trial registries or results databases must now include, at a minimum, all confirmatory clinical trials and all exploratory efficacy trials. At the same time, the revised position leaves the disclosure of Phase I trials to the discretion of IFPMA member companies.

“Our aim is to strike an appropriate balance,” commented the federation’s director general, Alicia Greenidge. On the one hand, she said, “we want to make available clinical trial information that can provide patients and health professionals with an idea of the likely efficacy of potential medicines. On the other, disclosure of early safety trial information cannot provide any useful insight into the potential efficacy of the compound trialled, but can make it easier for rival companies to gain an insight into the scientific approach of the company concerned”.

Industry should also “try to avoid needlessly increasing the total volume of clinical trial information that has to be sifted through by patients and doctors to find potential medicines which may be able to address a particular condition”, Greenidge added.

The new Joint Position comes into effect immediately and has been approved by the other participating pharmaceutical associations, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers’ Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). It replaces the previous IFPMA positions on clinical trial disclosure dated 5 September and 6 January 2005.