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Pharmaceutical doctors want all trial data published

Faculty of Pharmaceutical Medicine shows support for greater clinical transparency

Faculty of Pharmaceutical Medicine logoPharma companies should do more to improve the transparency of their clinical trial data, according to a survey of pharmaceutical doctors.

Data reported by the Faculty of Pharmaceutical Medicine (FPM), part of the UK's Royal Colleges of Physicians, showed that 81% of respondents thought that clinical trial sponsors had a “moral duty' to make data available to trial participants, general public and scientific community on completion of the study.

Even more (87%) pharmaceutical doctors - doctors who work in the pharmaceutical industry, drug regulatory authorities, contract research organisations and academia - said they believe that increased scrutiny of clinical trial data will result in a “stronger science base and enhance medical research”.

Healthcare practice was also a concern for doctors surveyed, and 89% said they believe that greater trial transparency, including the publication of negative results, will lead to better medicines and better patient care.

Dr Keith Bragman, president of the FPM, which also acts as a standard-setting body, 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.

“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.”

The survey was carried out between September 23 and October 28, 2013, and contains the views of almost 400 members of the FPM - about one quarter of the organisation's total membership.

Of particular note for the industry is that the majority of the respondents (59%) work for a pharma or biotech company. The remainder are independent (15%), work for a contract research organisation (13%), work for a regulator (3%) or are in academia or the NHS (2%).

The geographic reach of the survey showed that transparency is more than just a UK issue. Although 58% of the respondents are based in the UK, 25% are based elsewhere in the EU, 10% in the US and 8% in the rest of the world.

The FPM has already been active in pushing for greater data transparency adding its signature to the AllTrials campaign leading the call for pharma companies to provide greater access to clinical trial data.

Several pharma companies, such as GlaxoSmithKline, Pfizer and Johnson & Johnson, have announced changes to their data sharing policies as a result of this pressure, while the European Medicines Agency (EMA) is also finalising plans to make it easier for independent researcher to access clinical study reports.

The FPM's own guidance for its members has been developed using the survey results. It is due to be published for consultation this month.

Article by
Thomas Meek

1st September 2014

From: Research, Healthcare



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