IFPMA updates clinical trial transparency rules

The council of the International Federation of Pharmaceutical Manufacturers and Associations has approved an updated joint position on the disclosure of clinical trial information via registries and databases. This extends the range of studies that the group's member companies must provide information about, to include all confirmatory and exploratory efficacy clinical trials.

The IFPMA stressed: "this is a minimum standard: the new position explicitly leaves companies free to disclose Phase I trials at their discretion, for example, in patients for oncology and other serious life-threatening conditions.

The IFPMA's director general, Alicia Greenidge, said: "our aim is to strike an appropriate balance. On the one hand, 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 trialed, but can make it easier for rival companies to gain an insight into the scientific approach of the company concerned. We 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."