vfa wants to make study summaries available in the EU register

17.07.2014 17:45

According to the vfa, an increasing number of summarized results of clinical drug studies from the European Economic Area will be available on the website of the European Medicines Agency (EMA) from July 21, 2014.

The association wants to be up and running within two years www.clinicaltrialsregister.eu also upload summaries of older studies from 2004 onwards.

Birgit Fischer, the general manager of the vfa, said in this context: “We welcome the fact that this is a contribution to the provision of study findings that the EU has been planning for years. In this way, the contribution of research-based pharmaceutical companies to medical progress for patients and to science is better utilized – and it becomes even more understandable for everyone who is interested in the industry.”

The EU's new website will add study results that have not yet been covered by the companies' voluntary commitment, says Fischer. This means that the EU website could become the second main source for summarized study results alongside the clinicaltrials.gov study database, said Fischer.

The new regulation covers studies with adults and minors from drug development phases II to IV in which clinics from the European economic area (EU + Iceland, Norway and Liechtenstein) were involved; in the case of minors, also studies that were carried out exclusively elsewhere. The summaries were written in English, according to the vfa press release. The vfa wants to know how quickly these will become available for which studies www.vfa.de/ct-summaries explain.

Clinical study reports and raw study data

In addition to summaries of results, the vfa also discussed the publication of Clinical Study Reports (CSRs) in the press release. Birgit Fischer linked this to three conditions: “The industrial pharmaceutical researchers are prepared to share the CSRs with other scientists and the interested public in the future, as long as three things are guaranteed: data protection for all participants, confidentiality for trade secrets and protection against the misuse of CSRs early generic approvals in emerging markets.”