The Faculty of Pharmaceutical Medicine (FPM) has released survey findings on the publication of results and access to clinical trial data.
Based on the views of almost 400 members of the FPM, the results of the survey clearly favour registration of all clinical trials, earlier publication of the summary results of trials and increased access to the data from clinical trials. Some of the major facts and figures for respondents who completed all questions are outlined below:
The Faculty of Pharmaceutical Medicine (FPM) has released survey findings on the publication of results and access to clinical trial data.
Based on the views of almost 400 members of the FPM, the results of the survey clearly favour registration of all clinical trials, earlier publication of the summary results of trials and increased access to the data from clinical trials. Some of the major facts and figures for respondents who completed all questions are outlined below:
* 95% of survey respondents believe that all clinical trials should be registered.
* 89% believe that increased publication of clinical trial results (including negative results) will ultimately lead to better medicines and better healthcare for patients.
* 73% of respondents thought that clinical trials, irrespective of phase of development, should be published within 1–2 years of completion (not linked to market authorisation or discontinuation of the project)
* 87% believe that, overall, increased scrutiny of clinical trial data will result in a stronger science base and enhance medical research.
* Only 10% believe that increased publication and dissemination of clinical trial results will harm the commercial environment in which companies operate.
* 69% supported the requirement for retrospective release of clinical trials data, with the most commonly agreed time frame being data from ~5 years ago.
The results of the survey also provided very interesting comments and information on the current state of clinical trials registries. The matter of how to manage access to clinical trials data through an independent ‘gatekeeper’ also provided some very useful feedback, including how to manage the logistical and financial considerations, and whether there should be any constraints on who is allowed to access data.
The report has already 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 2014. The FPM has also made a number of recommendations in the report, which we hope 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 practising 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 Faculty has previously advocated increased transparency, but has also 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. 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.
I think the learnings from this survey will be most useful to all stakeholders as they continue to develop policies in these areas. I would encourage all sponsors of clinical research and all those involved in the practice of pharmaceutical medicine to read this report and do all they can to improve transparency and promote the timely publication of trial results.”
Copies of the full report (containing the full results from the survey) can be downloaded from https://www.fpm.org.uk/policypublications/access_clinical_trial_data
