Some 95% of pharmaceutical physicians believe that all clinical trials should be registered, and 89% say that the increased publication of trial results, including those that are negative, will ultimately lead to better medicines and better healthcare for patients, according to a new survey.
The poll, of members of the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians, has also found that 81% of respondents agreed with the statement that “there is a moral duty on all sponsors of clinical trials to make data available to the trial participants, general public and scientific community on completion of the study.” And 87% believe that overall, increased scrutiny of clinical trial data will result in a stronger science base and enhance medical research.
Just 10% considered that increased publication and dissemination of clinical trial results would harm the commercial environment in which companies operate.
Respondents to the survey work in a wide variety of environments, but when the results of those employed in academia or regulatory agencies, independent practitioners and those employed in the commercial sector were compared, very little difference was found in opinions between these groups.
Commenting, FPM president Keith Bragman said it was “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 the patient.”
73% of respondents told the survey that clinical trials, irrespective of phase of development, should be published within one to two years of completion, not linked to market authorisation or discontinuation of the project. And 69% said they support the requirement for retrospective release of trial data.
“We cannot write evidence-based guidelines unless all trials are registered and the results published within a reasonable timeframe of completion of the trial,” said Dr 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 patients 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,” he added.
The FPM says that the survey has already been influential in the development of the Faculty’s Code for Good Medical Practice in Pharmaceutical Medicine, which it will be releasing for public consultation in early September.
