Transparency campaigners welcome new rules for clinical trials in Europe

Members of the European Parliament have voted overwhelmingly to introduce a raft of legal measures to increase the transparency of clinical trials in Europe.

Campaigners for increased transparency have hailed the move as a step towards ensuring that future treatments are based on all the evidence, increasing the likelihood that licensed drugs are more effective and safer than before.

However, they said that their job was not yet done, as the complete evidence base for most drugs in current use remained undisclosed and should also be made publicly available.

From 2016, when the new clinical trials law is expected to come into force, all trials will have to be registered on a publicly accessible EU clinical trials register before they can begin, and a summary of the trial results will be required to be posted within a year of the end of the trial, along with a lay summary for the general public.

Altogether 594 MEPs voted in favour and 17 against adopting the proposals on tightening up regulations on clinical trials in Europe, which have been championed by the British Labour member of the European Parliament Glenis Willmott.1

The new law will also require clinical study reports (the detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced. Anyone running a clinical trial who did not adhere to these new laws will face financial penalties.

Founders of the AllTrials campaign (www.AllTrials.net) for all clinical trials to be registered and the results reported, which was launched in January 2013 by the BMJ and others, welcomed the vote.2

A BMJ deputy editor, Trish Groves, said, “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.”

Síle Lane, director of campaigns at the charity Sense About Science, who helped set up the campaign, congratulated MEPs for their decision, but she emphasised that details of past trials also needed to made publicly available. “Hundreds of thousands of people, patients mostly, have taken part in clinical trials that have never published results. This is a betrayal of their trust,” she said.

Ben Goldacre, author of Bad Pharma and co-founder of AllTrials, described the legislation as “an excellent small step forward.” He added, “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 AllTrials.net pledge.”

In February 2013 GlaxoSmithKline became the first drug company to join the campaign for transparency and said that it would make public the clinical study reports on all its approved drugs dating back to 2000.3

Johnson & Johnson, Pfizer, and Roche have set up schemes to field requests from researchers for access to their clinical trials data, although they have been criticised for excluding some trials and for being able to turn down requests as they choose.4 5