Richard Bergström, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has expressed support for the recent pledge from the European Medicines Agency (EMA) to increase transparency and access to information included in companies’ applications for marketing authorisation.
“For several years my members have shared summary results for all clinical trials involving patients,” he said. “Now is the time to take another step towards full transparency.
“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.
“The role of medical journals will also change. They will be more important than ever to summarise 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.”