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The European Medicines Agency has carried out a consultation on increased transparency and access to information included in companies' applications for marketing authorization. In its response submitted yesterday, EFPIA, the voice of the research-based pharmaceutical industry, expressed support for the release of almost all clinical data. "For several years my members have shared summary results for all clinical trials involving patients. Now is the time to take another step towards full transparency,” says Richard Bergström, Director General of EFPIA.
"There will be details on patients and individuals that need to be protected, but beyond that I think all clinical test results should be disclosed as soon as a new medicine is approved. The real challenge now is to find practical ways to make this data useful. No one will benefit from a "data dump." Industry and regulators must work with patient groups to make sure that data is provided in a way that is helpful for patients and relatives. New tools are needed to help users navigate and understand the vast amount of data that will be released. In particular the concept of benefit-risk needs to be clearly explained so that everyone who is interested can understand the reasons for approving a particular medicine," says Richard Bergström.
"The role of medical journals will also change: they will be more important than ever to summarize and explain research findings. But they must also adapt to the fact that key data may be disclosed by regulators before they are published in a journal. We must all adapt to the new era of full transparency," Richard Bergström concluded.
The submission of EFPIA comments on Draft HMA/EMA guidance document on the identification of CCI and PPD with the structure of the MA dossier is available for download here: http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=11908.