UK Pharma Doctors: Clinical Transparency Is Good For Science

The Faculty of Pharmaceutical Medicine (FPM) of the Royal Colleges of Physicians of the United Kingdom released the results of a study, which found an overwhelming majority of U.K. pharma doctors and industry experts are in favor of greater transparency in clinical trials.

The survey was conducted over the course of one month and was comprised of twenty-four questions which assessed the attitudes towards and experience with transparency in clinical trials. Respondents, who represented a quarter of FPM’s membership and who are employed in a wide variety of pharma careers, were urged to answer as doctors and scientists, not as employees of an organization.

The survey reports that 89 percent of respondents “believe that increased publication of clinical trial results (including negative results) will ultimately lead to better medicines and better healthcare for patients.”

Eighty-one percent believe there is a “moral duty” on the part of sponsors to make data collected available to the trial’s participants, general public, and scientific community when the study concludes.

According to Keith Bragman, president of the FPM, “We should not be willing to sacrifice the needs of patients for unnecessary secrecy.”

While Bragman did specify that commercial interests of sponsors should be considered, only 18 percent of respondents believed that the transparency would have an effect on the pharma business.

Tonio Borg, E.U. Health Commissioner, estimates that greater clinical trial transparency and the sharing of clinical results could actually save research companies a lot of money — approximately 1 billion dollars per year.

While the U.K. respondents agreed that greater transparency was both morally and fiscally responsible, their opinions diverged on the subject of implementation. Questions of where the data would be collected and how and whether or not an independent organization should serve as gatekeeper, among other concerns, will be open for debate in the coming years.

The exact parameters for this new style of clinical research may not be clear, but recent legislation and government action indicates it will shortly become a reality. E.U. lawmakers voted in April of this year in favor of new regulations that would require more open reporting of clinical trial results. The legislation is expected to be put into effect in 2016.

Meanwhile, the FDA recently expressed similar commitments to fostering a more open clinical environment in its blog, the FDA Voice.

With all the efforts underway to establish more data transparency in the clinical space, the industry is becoming more optimistic that those in favor of greater transparency will soon see results. Kevin Outterson, professor at Boston University, wrote an opinion piece about transparency for the New England Journal of Medicine, which began with this preamble: “This year promises to be an auspicious period for some long-running battles over the dissemination of biomedical research.”