It’s going to be a ‘big-ish’ month in the EU for clinical trials.
By most accounts, EU legislators will reach a compromise agreement on the proposed new Clinical Trials Regulation in time for Christmas. The key focus for industry bodies is around making sure the legislation embraces aggressive timelines for the approval of clinical trials.
Remind me, isn’t there a well-known saying about ‘haste’ and ‘speed?’
Anyway, I am afraid industry interests dominate the corridors and bars of Brussels and most of the self-proclaimed ‘patient-groups’ lobbying on this legislation bought into the corporatisation of clinical research long ago. So, what we have had is lots of industry positioning coolly argued as meeting ‘patient need,’ but very little acknowledgement of patient rights.
Last week the industry-backed European Federation for Good Clinical Practice (EFGCP) sent out their report of the ‘Multi-Stakeholder Roundtable Meeting on Sharing Clinical Trial Data in the Interest of Patients and Research’ which they hosted in October. I was struck by this quote from the report:
“One – perhaps unexpected – outcome was a focus on the participants in clinical trials. “We have to do a lot more to get back to individual patients involved in clinical trials,” said Ingrid Klingmann (EFGCP). “We owe that to patients for their willingness to contribute to the trial. At present that concept is not embedded in the proposed Regulation – but as a fundamental right it should be.”
Perhaps it was unexpected because there hasn’t been any meaningful dialogue with patients about what they want from clinical trials. And I don’t just mean about the outcome of such research, but how people would like these studies to be conducted.
Question is….have EFGCP and others listened to the patient voice? And, if they have, whether we can expect them to urge for the legislation to embrace the right of people to receive the results of trials they have been part of and for all studies to involve patients and the public to be involved in their design.
Must go. Haven’t quite finished my letter to Santa.