Interview with Dr Síle Lane, head of international campaigns and policy at Sense About Science, about Re-engineering pharmaceutical research.
Undisclosed clinical trial results are unfortunately common – how does this impact progression in research and treatment?
Síle Lane: When results from clinical trials aren’t published it means the same research can get repeated unnecessarily. This wastes funds and time, meaning new research might not happen so opportunities to explore new areas and to progress the evidence base are missed. Failure to publish results from clinical trials puts the people who volunteer for repeated trials at risk unnecessarily. When research is not peer reviewed and is not opened up to scrutiny by the research community, we miss opportunities to improve research. We know that often it is trials that give so-called negative results that most often goes undisclosed, so not only does the evidence base for our medicines have gaps, it is also biased. Decisions made on the basis of the evidence base risk being wrong. Systematic reviews and meta-analyses – the gold standard of evidence – are at risk of being incomplete and biased, meaning that guidelines and decisions based on them may be wrong.
Could you explain the TrialsTracker tool – its purpose and highlight a main finding?
Síle Lane: The EUTrialsTracker Tool is an interactive website, built by Dr Ben Goldacre’s team at the University of Oxford and part of the AllTrials campaign, that pulls in information from the EU’s clinical trial register and displays which clinical trials are due to have reported results. There is an EU rule that every clinical trial registered onto the EU register must report results on the register within 12 months of the end of the trial. The EUTrialsTracker assesses for every clinical trial whether it is due to reported results or not, assesses whether there are results for it on the register, and characterizes each trial as reported, not reported or not due to report. Currently, in December 2019, it shows that 63% of all EU trials that are due to have reported results have. This means that around a third of European clinical trials have failed to report results and are breaking the rules. When we launched the EU TrialsTracker in September 2018 we looked a little more closely at the kinds of clinical trials that were not being reported. We saw that European academic institutes were lagging far behind companies in complying with the reporting rules – 68% of company-sponsored trials that were due to report results onto the register had, but only 11% of academic trials had. This means that nearly 90% of the trials sponsored by European universities, governments, charities and research centres were breaking EU rules.
What could the EU institutions potentially do to improve the situation? What do you think the future holds?
Síle Lane: There are a number of things that different EU institutions can do to improve the situation. Number one is to bring the EU Clinical Trials Regulation into force. It has been delayed for a number of years now. It has provisions in it that mandate that all EU and EEA clinical trials are registered before they begin and report results within 12 months of their end and, significantly, introduces the possibility of sanctions including financial penalties for clinical trial sponsors who break the law. Once the new clinical trials law is in force it must be monitored and policed. The US law, the FDA Amendments Act 2007, mandates that certain US clinical trials must be registered on the federal register before they begin and report results there within a year of the end of the trial, and gives the FDA power to fine research sponsors who breach these rules. Despite the fact that hundreds of applicable trials are going unreported, the FDA has never issued any fines and adherence to this law is patchy.
The EU itself funds clinical trials for example through the Horizon 2020 Societal Challenge (Health Demographic Change and Wellbeing) scheme. The EU should commit to the AllTrials’s asks for clinical trial funders:
- Make registration of the clinical trial and reporting of the results, whatever the result, a condition of all new funds;
- Mandate that researchers must have reported results for all previous research to be considered for new funds;
- Ensure that grantees understand that the costs, if any, of registering the clinical trial and reporting results can be covered by grant funds.
Síle Lane: There are no longer any excuses for any results of a clinical trial not to have been published. It is already becoming the exception instead of the norm to not have disclosed results. Soon it will be professionally problematic for a researcher not to have published results, given that it probably means they are breaking a law, it is increasingly being viewed as research misconduct and it will become a barrier to getting new funds.