The European Parliament approved a long-awaited bill that will unify clinical trial information into one European Union database and require trial investigators to publish summarized results publicly. The bill, which passed on April 2 with a landslide of 594 votes in favor (with 17 against), was the expected outcome of a provisional parliamentary agreement reached in December. The law is expected to streamline approval for clinical trials and to increase their transparency.

“Currently only half of clinical trials are published, and positive results are more likely to be published than negative results,” said Glenis Willmott, the English parliamentarian who steered the bill through the various stages, in a statement before the vote. “This can give a biased picture about the safety and efficacy of medicines and can lead to unnecessary or even dangerous trials being repeated. So the transparency measures this law will put in place are a huge step forward.”

Once the law is fully implemented, which is predicted to happen no earlier than 2016, companies and research institutions will submit applications for trial approval into a centralized “EU portal” overseen by the European Medicines Agency (EMA). The portal is expected to simplify the approval process, especially for clinical trials conducted in more than one of the EU’s 28 member countries. Currently, such trials go through separate approval procedures in each country, a costly process that lawmakers said is particularly burdensome for small companies or academic research institutions. “At the moment it is just too difficult and expensive,” Willmott said. This new regulation would radically change that, she said.

The cohesive system may particularly benefit investigators studying rare diseases. These often need trials that span several countries to enroll enough patients, said Cristina Sampaio, who left the EMA to become the chief medical officer of CHDI Foundation in Princeton, New Jersey. “Doing trials in only two to three countries is a model that is not appropriate for rare disorders, so I think the concept the bill proposes will advance our cause,” she said.

Once trials are approved and underway, trial sponsors will be required to report any fatal or life-threatening events within seven days of becoming aware of them, and will submit annual safety reports to the EU portal throughout the trial. Within one year of a trial’s completion, companies or institutions will need to submit a summary of results, including de-identified patient information (such as age and gender), as well as a full statistical analysis of all relevant outcomes. A summary understandable by laypersons will also be required at that time. If a sponsor submits a drug for approval, it will need to file a more detailed clinical report, even if the drug never makes it to market.

The new law expands and builds upon a 2010 ruling by the European Ombudsman, which required the EMA to release de-identified trial results upon request (see Nov 2013 news story).  Two pharmaceutical companies—AbbVie Inc., of North Chicago, Illinois, and InterMune Inc., of Brisbane, California—subsequently filed lawsuits against the EMA to block the release of trial data. The day after the new law passed, AbbVie dropped their lawsuit. “It’s great to hear that one pharmaceutical company has backed down and I hope the one remaining legal challenge will also be dropped,” Willmott said on her webpage

The European Federation of Pharmaceutical Industries and Associations (EFPIA), Europe’s pharmaceutical trade organization, came out in support of the bill (see statement). 

Implementation of the bill will not begin until the EU portal and database are up and running, and member states have officially integrated the law into their national legal systems. Member states will also be responsible for imposing fines when companies or institutions do not comply with the new law. “I’m still a little skeptical about whether the law will be truly enforced, and it will take years until we find out, as the database isn’t ready yet,” said Sampaio. “It’s really a big question mark of how this will pan out in reality, but it’s an opportunity.”—Jessica Shugart 

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References

News Citations

  1. Opening the Doors to Clinical Trial Data

External Citations

  1. bill
  2. webpage
  3. statement

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