Glenis Willmott

EU votes for trial transparency

pharmafile | April 3, 2014 | News story | Research and Development, Sales and Marketing ABPI, EFPIA, EU, Goldacre, UK, alltrials, transparency, willmott 

Europe took a decisive step toward forcing pharma to open up its clinical trial data last night, after the EU Parliament passed new laws to ensure new drug studies are publicly registered and their results reported.

MEPs voted by a large majority to adopt the new Clinical Trials Regulation with 547 in favour, and just 17 against.

The new Clinical Trials Regulation says that information from clinical trial study reports should not be considered commercially confidential, thus removing any legal framework for pharma to not publish its data.

Other key changes see Europe:

  • Require that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register
  • Require that a summary of the results from these trials is published on the register within a year of the trial’s end
  • Require that a summary understandable to a lay person of what was found in the trial is published on the register
  • Require Clinical Study Reports (detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced
  • Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency
  • Require that all trials used in support of an application to run a new clinical trial are registered or have published results
  • Impose financial penalties on anyone running a clinical trial that does not adhere to these new laws.

The new rules were put on the European agenda by the UK MEP Glenis Willmott, who says that this is a “victory for transparency and medical research”.

It has also been a victory for the AllTrials campaign group which has been for the past year pushing for greater clinical trial transparency in the UK and Europe. But despite this vote last night the group is cautious over the future, and says there is still more to be done.

Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials, says: “This is an excellent small step forward after some really good work by MEPs. But the new EU legislation is only concerned with new trials.

“It does not address the far bigger problem, that we still don’t have full reporting for all trials on the medicines we are using right now, today, medicines which we will continue to use for the foreseeable future.

“Doctors and patients simply cannot make informed decisions about which treatment is best, when the evidence on the treatments they are using is still being routinely and legally withheld. We need all trials – on all uses of all currently prescribed treatments – to be made available, and urgently.

“There is no excuse for industry inflicting ongoing harm on patients, and on their own reputation, by continuing to campaign against this position. They should join their more ethical colleagues, and sign up to the pledge.”

Dr Trish Groves, deputy-editor of the BMJ, co-founding organisation of the AllTrials campaign, adds: “Having methods and results of all drug trials in the public domain is a big advance and discussions have already started about the practicalities, upsides, and what some may see as potential downsides of sharing this information.

“It’s time for medical educators, investigators, funders, sponsors, ethics committees, and most importantly – trial participants – to prepare for an era of much greater openness.”

The new rules are expected to come into effect in mid-2016 at the earliest, and then all EU Member States will adopt the laws into their own statutes.

The European Medicines Agency however can now start building the new publicly accessible online clinical trial database, something that is currently not viewable by the public. 

Industry reacts

The pharma industry in Europe has been rallying against the plans with lobby group EFPIA wanting self-regulation, rather than any imposed new rules.

In the face of this vote however, the group has struck a more conciliatory tone by saying it “welcomes the decision reached by the European Parliament in [the] plenary vote towards the adoption of the new Clinical Trials Regulation”.

It says it also welcomes the legislation’s ‘approach to transparency’, which “respects the need to protect personal patient data and commercially confidential information”.

Its UK counterpart the ABPI struck the same chord, adding simply: “The ABPI also welcomes the adoption of new transparency requirements for the disclosure of clinical trial information.

“We commend the progress all parties have made in reaching an agreed European position, which also reflects a commitment to the protection of personal patient data and commercially confidential information.”

Ben Adams

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