Pharmaceutical companies and academic researchers will have to post the results of all their European clinical trials in a publicly-accessible database, under a draft law already informally agreed with E.U. ministers and passed by Parliament. The law also facilitates cross-border cooperation to make clinical trials larger, more viable and more reliable, which should in turn boost efforts to develop special treatments (e.g. for rare diseases).
"I am delighted that the overwhelming majority of MEPs backed this deal. It will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe," said Glenis Willmott, who steered the legislation through the European Parliament. Her report was approved 594-17, with 13 abstentions.
"The new law also will offer hope to the millions of people in Europe suffering from rare diseases, by making cross-border trials much easier to conduct. There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases. By working at E.U. level, we can reduce the huge cost and burden of conducting trials across borders," she added.
The legislation will streamline the rules on clinical trials across Europe, facilitating cross-border cooperation to enable larger, more reliable trials, as well as those on products for rare diseases. It simplifies reporting procedures, and empowers the E.C. to do checks. Once a clinical trial sponsor has submitted an application dossier to a member state, the member state will have to respond to it within fixed deadlines.
The new Clinical Trials Regulation says that information from Clinical Study Reports of trials should not generally be considered commercially confidential and will require:
All drug trials in Europe be registered before they begin on the publicly accessible E.U. clinical trials register
A summary of the results from these trials be published on the register within a year of the trial’s end
A summary understandable to a lay person of what was found in the trial be published on the register
Clinical Study Reports (detailed documents normally produced for regulatory processes) be made publicly available, where they are produced
Establishment of a new publicly accessible E.U. clinical trials register, to be set up and run by the EMA
All trials used in support of an application to run a new clinical trial be registered or have published results
Financial penalties be imposed on anyone running a clinical trial who does not adhere to these new laws.
Ben Goldacre, co-founder of AllTrials, an initiative focused on clinical trials transparency, said, “This is an excellent small step forward after some really good work by MEPs. But the new E.U. 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.”
