The push from the UK for wholesale transparency of clinical-trial data has taken on a new dimension with the launch of the AllTrials public campaign.
An accompanying petition – already close to 3,000 signatures at the time of writing – calls on governments, regulators and research bodies to put in place measures ensuring that “all trials past and present” are registered and “the full methods and the results” reported.
The initiative follows last month’s call by the UK House of Commons Science and Technology Committee for submissions on transparency and the disclosure of study data as part of a broader inquiry into clinical trials.
Among the campaign backers are some familiar names in the recent drive for clinical-data transparency: Bad Science – i.e., epidemiologist and Bad Pharma author Dr Ben Goldacre; the BMJ; the James Lind Initiative; and the Centre for Evidence-Based Medicine.
Joining them in the campaign is Sense About Science, a UK-based charitable trust that works in partnership with scientific bodies, research publishers, policymakers, the public and the media to change public discussions about science and evidence.
Sense About Science director Tracey Brown commented: “Everybody agrees that all clinical trials should be registered, and that we should at the very least have access to the basic results, and ideally the full Clinical Study Reports. But there have been years of foot-dragging and non-compliance with requirements.”
Government and regulators “must listen to what the public thinks about this”, Brown insisted. “It’s a vital matter of public interest for the medicine we have now and the medicines we might have in the future.”
The campaigners call in particular on the European Medicines Agency to take action.
“The EU Clinical Trials Regulation is currently before the European Parliament with deadlines for amendments in mid-February,” they note. “The Regulation does not contain measures to ensure comprehensive registration and reporting of trials relating to drugs and practices in current use.”
Richard Stephens, chair of the National Institute for Health Research Cancer Consumer Liaison Group, argued that if patients are to contribute to the research effort, they will want to be sure the findings were optimally distributed.
“The Department of Health report, Innovation Health and Wealth, sets out a goal for the NHS that every willing patient should be able to take part in research,” Stephens observed.
“We expect that the results of trials will be made freely available to researchers, clinicians and administrators, in order to deliver better treatments, better services, and better outcomes for patients.”
According to Goldacre, AllTrials will “run a public campaign, build an informative website, lobby politicians and stakeholders, brief journalists and make it news”.
Nobody profits from secrecy, “least of all industry”, he argues. “The one thing that has perpetuated the current situation is a lack of public awareness.”
The House of Commons Science and Technology Committee is asking for written submissions by 22 February 2013 on the following issues:
• Do the European Commission’s proposed revisions to the Clinical Trials Directive address the main barriers to conducting clinical trials in the UK and EU?
• What is the role of the Health Research Authority (HRA) in relation to clinical trials and how effective has it been to date?
• What evidence is there that pharmaceutical companies withhold clinical trial data and what impact does this have on public health?
• How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?• Can lessons about transparency and disclosure of clinical data be learned from other countries?