Last
week, a study published in the BMJ reignited the debate about research transparency.
Dr Ben Goldacre and colleagues reported that half of European clinical trials
hadn’t complied with EU rules on reporting results
Although there were some positive signs in the report - a high rate of compliance among commercial sponsors and those conducting a large number of trials, for instance - overall it painted a concerning picture.
The BMJ study authors discuss some of the reasons for poor reporting by non-commercial sponsors or those doing fewer trials, suggesting a lack of awareness of the requirements, poor processes or unclear lines of responsibility (sponsors are responsible for reporting, yet it’s the Chief Investigator or administrators who lead on reporting results). However, commenting on the study, the AllTrials campaign said ‘there is no excuse for failing to report results’.
Are university-sponsored researchers just making excuses or are there genuine barriers to research transparency here? Commercially-sponsored research has the kind of funding and infrastructure for analysis and writing up results that university-sponsored research sometimes lacks. Are academics struggling to find the time and resources for these activities? Our own research suggests that awareness of responsibilities is also an issue.
Those undertaking non-commercial research need to ensure that at the outset they have the resources to complete their study, including reporting results and publication in a timely manner. It is a clear responsibility of health and social care research sponsors that clinical trials are registered and the results of all types of research are made public. If that doesn’t happen, funding is wasted, as are the efforts of all involved in the research, not least the participants.
We need to better understand whether resourcing is the primary driver for achieving compliance in the commercial sector or whether they have a different approach that could be applied across the system.
So what can we at the HRA do to change behaviours? Initiatives like this report that publicise poor practice and name those responsible can be one effective way of improving poor performance. A number of sponsors and the regulator itself, the European Medicines Agency, have already responded positively to the BMJ study. Our own follow-up with applicants to audit compliance with registration requirements has prompted better performance, showing that reminders can change behaviour.
But these are resource-intensive methods to achieve what ought to be second nature to researchers. We are working on a number of fronts to encourage researchers to get it right, particularly around trial registration. That includes continuing to raise awareness of requirements by improving communication with applicants at crucial points in the approval process about our expectations around registration and making results public. Part of that it about being clearer, but it’s also about building automatic prompts into our systems to make it easier to comply.
We’re also looking at how we can put greater pressure on sponsors to take responsibility for ensuring that the research they sponsor meets the transparency expectations in the UK Policy Framework for Health and Social Care Research. Part of this involves working with the R&D Forum on ‘good sponsorship’.
It’s not straightforward, and we’re clear we don’t want to put in place an inflexible system that wrongly prevents important research from happening. But as the study published in BMJ pointed out, the near perfect compliance among commercial sponsors conducting a large number of trials shows it can be achieved.
If you’ve not had an opportunity to fill in our survey, you can find it here. You have until the end of the month to complete it and we’ll publish the results on our website later this year.