Research funders pledge transparency on trial results

International medical funding bodies, including the UK Medical Research Council and the Wellcome Trust, have committed to registering the results of all trials, even if they are negative.

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Some of the world’s largest research funders have pledged to make all their trial results publicly available, meaning that doctors and other prescribers will be able to make better informed choices.

In a joint statement issued on 24 May 2017, ten international medical funding bodies — including the UK Medical Research Council and the Wellcome Trust — say that all trials they fund, co-fund, sponsor, or support will be registered in a publicly available registry.

The statement adds that all results will be disclosed either on the registry or in a scientific journal.

Other funders who joined forces in issuing the statement include: the Indian Council of Medical Research, the Norwegian Research Council, Médecins Sans Frontières and Epicentre (its research arm), the international non-profit organisation PATH , the Coalition for Epidemic Preparedness Innovations, Institut Pasteur and the Bill & Melinda Gates Foundation.

Catherine Duggan, director of professional development at the RPS, welcomes the announcement, saying the RPS has supported the AllTrials campaign calling for greater transparency.

Source: Simon Wright Photography / The Pharmaceutical Journal

Catherine Duggan, director of professional development at the RPS, says that open access to information on research results, whether positive or negative, is vital to better inform on safety and efficacy of medicines, reduce duplication in research and accelerate the development of new medicines.

“Open access to information on the results of research, whether positive or negative, is vital to better inform our understanding of the safety and efficacy of medicines, to reduce duplication in research and allow us to accelerate the development of new medicines,” she says.

“It will also support pharmacy professionals to continue to make informed choices about medicines use.”

Campaigners have long been pushing for more transparency on publication of all clinical trial data.

Standards published by the World Health Organization (WHO) in 2015 called for every human research study to be registered in a public database.

Results from several studies, including a 2010 review from the University of East Anglia, have shown that around half of all trials go unreported and are more likely to remain hidden if results are negative.

Marie-Paule Kieny, assistant director-general for health systems and innovation at the WHO, says: “Research funders are making a strong statement that there will be no more excuses on why some clinical trials remain unreported long after they have completed.”

Jeremy Farrar, director of the Wellcome Trust, says: “Not only will this help ensure that these research findings are more discoverable, but it will also reduce reporting biases, which currently favour publication of trials which have a positive outcome.”

Leyla Hannbeck, chief pharmacist at the National Pharmacy Association, says increasing the amount of data that is publicly available will enable community pharmacists as the drug experts to offer more “informed choices”, based on the unbiased results.

“Over the past few years, there has been a number of new safety warnings for drugs issued by regulators and manufacturers based on post-marketing experience,” she says.

“In a few cases, some drugs have had their licence withdrawn due to significant safety concerns.

“Having this research data published will ensure that drugs entering the market have safety and effectiveness data available to give healthcare professionals and clinical guideline developers the tools to put the patient’s safety central to their decision-making,” she adds.

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Citation
The Pharmaceutical Journal, May 2017;Online:DOI:10.1211/PJ.2017.20202853