The Faculty of Pharmaceutical Medicine (FPM), a professional membership organization of the Royal Colleges of Physicians of the U.K., has released results of its survey on the publication of clinical trial results and access to data.
Based on the views of almost 400 members of the FPM, survey respondents clearly favor registration of all clinical trials, earlier publication of trial summary results and increased access to the trial data.
Some of the key facts and figures the survey revealed include:
95% of survey respondents believe all clinical trials should be registered
89% believe increased publication of clinical trial results (including negative results) ultimately will lead to better medicines and better healthcare for patients
73% of respondents thought clinical trials, irrespective of phase of development, should be published within one to two years of completion (not linked to market authorization or discontinuation of the project)
87% believe, overall, increased scrutiny of clinical trial data will result in a stronger science base and enhance medical research
Only 10% believe increased publication and dissemination of clinical trial results will harm the commercial environment in which companies operate
69% support the requirement for retrospective release of clinical trials data, with the most commonly agreed time frame being data from approximately five years ago.
The report already has been influential in the development of the FPM’s Code for Good Medical Practice in Pharmaceutical Medicine, which is being released for public consultation in early September. The FPM also has made a number of recommendations in the report, which it hopes will be adopted and implemented by the relevant stakeholders.
Dr. Keith Bragman, president of the FPM, said, “It is very gratifying to note that, as doctors practicing pharmaceutical medicine, we see the world of publication of clinical trial results and access to data in a common light. Namely, we have a responsibility to patients. The FPM has previously advocated increased transparency, but also has been supportive of the need to identify and implement remedies which protect the privacy and rights of patients and research subjects, and the interests of all stakeholders.”
“We cannot write evidence-based guidelines unless all trials are registered and the results published within a reasonable time frame upon completion of the trial,” said Bragman. “We cannot satisfactorily answer questions unless we have access to results and data, whether positive or negative. There must be protection of the anonymity of people who participate in research. We cannot educate those who are unaware unless we are first prepared to reveal, in a timely manner, the results of clinical trials.”
Data for the survey was collected from Sept. 23, 2013, to Oct. 28, 2013.
