A GLOBAL campaign to publish all clinical trial results within a year of trial registration has been ramped up, but the Australian and New Zealand Clinical Trials Registry will not be signing up — at least, not yet.
National manager of the registry, Dr Lisa Askie, told MJA InSight she remained supportive of the general principles of AllTrials — a worldwide organisation campaigning to have all clinical trials registered and reported — but had “some concerns”.
“We fully support the overall principles stated by AllTrials, but we wouldn’t sign up to it based on the current documents, though we welcome that they’ve put out their statement and that they’re calling it a ‘working document’ up for discussion”, she said. (1)
The AllTrials campaign, spearheaded by open trials advocate Dr Ben Goldacre, author of Bad science and Bad pharma, has called for all clinical trials worldwide, past and present, to be registered, and for full methods and results to be published. (2)
Organisations already signed up include the UK Medical Research Council, the Cochrane Collaboration and the World Association of Medical Editors.
Dr Aksie was commenting on a position statement released by AllTrials last week aimed at countering criticism that its plan would threaten the privacy of individual trial participants, saying it was “not calling for individual patient data to be made publicly available”.
Professor Paul Glasziou, director of Bond University’s Centre for Research in Evidence-Based Practice, told MJA InSight that it was well established that about half of all clinical trials conducted worldwide go unpublished.
“And the half that are published are biased in favour of positive results”, he said. “So not only are we wasting money and time on trials that aren’t published, but we’re also distorting the research.”
A systematic review conducted in 2010 showed that positive results were published more often and more quickly than negative ones, resulting in publication bias. (3)
“This means that we are misled about the benefits and risks of treatments”, Dr Goldacre said in a recent briefing note on missing data. “We can be misled into prescribing an expensive new drug, for example, when in reality an older cheaper one is more effective. Patients are harmed and money is wasted.” (4)
The AllTrials campaign was launched in January this year and its latest statement calls for initiatives in three areas — the registration of all clinical trials, past and present, including a summary of protocol; a summary of results to be made publicly available where the trial was registered, within one year of completion of the trial; and public availability of reports for marketing authorisation or any other purpose.
Dr Askie agreed that the general principles of the AllTrials campaign were laudable but was sceptical about how the campaign’s suggestions could be made operational.
“I question their idea of a centralised registry system. A better way to get complete and comprehensive registration would be to strengthen trial registries in individual countries, particularly non-English speaking countries”, Dr Askie said.
“Can you see Iran, for example, being happy to register with a US-backed registry? Or Pakistan registering their trials with an Indian database? How would that work in terms of increasing compliance?”
She said the ANZCTR was already doing many of the things suggested by AllTrials, although she conceded the system could be “streamlined” further.
Professor Glasziou said trial registers had been around for a long time, but compliance was low because of the investment needed to compel it.
“The National Institute of Health Registers in the UK gets close to 100% compliance and that’s because they invest time into making sure results are published”, he said. “They actively chase researchers for their results, find out what the problems are and solve those problems for people.
“While the [AllTrials] proposals are relatively simple, achieving this will take a sustained effort by the many players involved”, Professor Glasziou said.
“To ignore the call will mean to continue to accept the billions of dollars we waste in the research effort [of non-published trials] and poor or distorted reporting.”
1. AllTrials campaign 2013; All trials registered. All results reported
3. Health Technology Assessment 2010; Dissemination and publication of research findings: an updated review of related biases
4. AllTrials campaign 2013; Missing trial data — briefing notes