AllTrials campaign writes to every MEP on the ENVI committee before the vote on the clinical trial regulation tomorrow. If you haven’t written to your MEP yet, please feel free to use some of this letter. All the MEPs’ details are here.
Dear [Member of the ENVI committee] MEP
On Wednesday 29th May the ENVI committee will vote on amendments to a regulation on clinical trials. The AllTrials campaign is urging you to vote in favour of amendments that would increase transparency around clinical trials and to reject amendments that would strengthen the protection of commercial confidentiality.
The AllTrials Campaign for all clinical trials to be registered and results reported was launched in January 2013. It is supported by 53,000 people and more than 320 organisations including regulators; medical schools and universities; medical bodies and Royal Colleges; consumer group BEUC, the European Patient’s Forum and more than 100 other patient groups from across Europe.
Please vote for compromise amendment 11 which asks clinical trial sponsors to submit a summary of the results to the EU database within a year of the trial’s end.
The Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects already calls for the reporting of results from clinical trials. Point 30 reads in part: “Authors have a duty to make publicly available the results of their research on human subjects.”
Patients participate in clinical trials on the understanding that their participation will benefit the advancement of science. Allowing findings generated by their participation to be hidden away is a betrayal of patients’ trust, as fifty patients wrote to the European Medicines Agency (EMA) in January 2013. http://www.alltrials.net//wp-content/uploads/2013/01/letter-to-EMA-from-clinical-trial-participants-2013-Jan-18.pdf
Please vote for consolidated amendments 40 and 41 which say that there is no commercially confidential information in clinical study reports or in clinical trial data once a marketing authorisation for the medicinal product for which trial was conducted has been granted, or the decision-making process on an application for a marketing authorisation has been completed.
The European ombudsman has declared that there is no commercially confidential information in trial protocols or clinical study reports, especially once a marketing authorisation has been granted. http://www.ombudsman.europa.eu/cases/draftrecommendation.faces/en/4883/html.bookmark
The EMA’s access to documents policy supports this and complies with the European freedom of information regulation (Regulation (EC) No 1049/2001).
The EMA working group on legal aspects of clinical trial data release said that “No evidence has been put forward of a specific case where information contained in clinical trial data reveals details of what other molecules might be developed. Indeed, it would seem very unusual that such data, designed to test the safety and effectiveness of a specific molecule, would reveal any information in relation to the development of other molecules.” http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04/WC500142857.pdf
By claiming that publication of trial results is breaching commercial confidentiality pharmaceutical companies are arguing for the right to keep secret information that could save lives and advance medical research. Incomplete information from clinical trials means doctors could make bad treatment decisions and miss opportunities for good medicine. When researchers don’t know what was found in previous trials, or even that some trials happened, clinical trials are repeated unnecessarily.
Please get in touch if you have any questions and for more information on any of the points in this letter or the AllTrials campaign.
Yours sincerely
AllTrials campaign steering group:
Bad Science
BMJ
Centre for Evidence-Based Medicine
Cochrane Collaboration
James Lind Initiative
PLOS
Sense about Science
The complete list of organisations that are part of the campaign is available at http://www.alltrials.net/supporters/