EU Parliament, ministers agree to more clinical trial transparency in clinical trials
MEPs reached on Friday (20 December) an agreement with member states on the clinical trials directive.
Under the new agreement, pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database.
The deal also include that a publicly accessible EU database will be set up and run by the European Medicines Agency (EMA) which will contain a register of all trials carried out in the EU, a summary of results for all trials, uploaded one year after the end of the trial at the latest.
A summary understandable to a layperson would also have to be included from the pharmaceutical companies as well as clinical study reports for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn.
The pharmaceutical industry has come under fire over recent years over lack of transparency on clinical trials. Those accusations were epitomised in a book, Bad Pharma by Ben Goldacre, a research fellow of epidemiology at the London School of Hygiene and Tropical Medicine, and a co-founder of the transparency campaign All Trials.
Earlier this year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) made new commitments, which include improving data sharing with researchers, enhancing public access to clinical study information, sharing results with patients who participate in clinical trials, certifying producers for sharing clinical trial information and publishing clinical trial results.
But EFPIA emphasised that full transparency would hurt the industry, which relies on protection of trade secrets to compete in Europe and across the world.
Under the agreement, member states and MEPs say that Clinical Study Reports should, in general, not be considered commercially confidential and member states can impose fines over non-compliance with the transparency requirements.
The EU's Clinical Trials Directive was adopted in 2001 with a view to improving research standards and protecting patients.
But the directive has been heavily criticised by researchers who say insurance costs and red tape have increased without bringing any major benefits to patients, researchers or industry.
The Commission has therefore proposed revamping the directive to address those challenges.
Enhancing the competitiveness of clinical research was a primary reason for revising the directive, amid claims that Europe would become an unattractive place to conduct large-scale trials on potentially lucrative medicines.
The regulation also speeds up how researchers get ethical approval for medical trials and seeks to improve standards in how new medicines are tested and manufactured.
- March 2014: The overall deal to be approved by the Environment, Public Health and Food Safety (ENVI) committee, and then the whole Parliament.