Publish all trial results within a year or face disciplinary action, BMA says

The BMA has backed mandatory publication of all clinical trial results, irrespective of whether they are positive or negative, and disciplinary action for doctors who elect not to publish data.

Representatives at the association’s annual meeting in Edinburgh this week passed a motion insisting that all trials relating to drugs and other therapeutic interventions be registered and their results made available within one year of completion.

Selective non-publication of “unflattering” trial data represented research misconduct and merited referral of the doctors involved to the General Medical Council, doctors agreed.

Suffolk representative John McGough said that holding back negative trial results could make the effects of a drug or device look more significant than they really were. “This motion is not just for our purposes as doctors or for the completeness of science, it is most importantly for our patients, who stand to suffer from a lack of efficacy or even worse from harm from some treatments,” he told the conference.

Drug companies sometimes buried negative results because they feared that the data might affect sales or commercial confidentiality, said medical student David Carroll. “We as an organisation, as a professional body, need to say that enough is enough,” he added. “We need to put the ‘evidence’ back in ‘evidence based medicine.’”

However, the consultant Jan Wise warned that some doctors who had not published trial results might not be purposely concealing data. “Given the pressures of time on doctors, is it really deliberate on their part, or are they prioritising appropriately?” he asked.

The General Medical Council’s guidance on good practice in research states that doctors must report research results “accurately, objectively, promptly and in a way that can be clearly understood.”1 Doctors who breach this guidance by not publishing negative trial data could be subject to fitness to practise procedures, the GMC has confirmed.

In March this year the BMA signed up to the AllTrials campaign (www.alltrials.net) for registration and publication of all clinical trials.2 Ben Goldacre, cofounder of AllTrials, said that the BMA’s vote describing the selective non-publication of trial data as research misconduct was “hugely important.” He said, “In medicine, our treatment decisions are based on evidence. If that evidence is distorted, by trial results being withheld from doctors and researchers, then we cannot make informed decisions about which treatment is best.”

Niall Dickson, chief executive of the GMC, said, “We support openness and transparency in research and clinical trials and expect doctors to publish results, including adverse findings. Any doctor who wilfully suppresses the results of research would be putting their registration at risk.”