Clinical trials run in the UK will be automatically registered from 2022, the country’s Health Research Authority announced today.
The new system seeks to ensure that every single clinical trial with be listed on a trial registry from the outset. UK researchers have been formally required to register trials since 2013, but that rule was never enforced, and many trials remained unregistered.
WHY IS THIS GROUNDBREAKING?
Trial registration is a key pillar of clinical trial transparency.
It helps scientists to gain an overview of who is currently researching which treatments, preventing needless duplication of medical research efforts . In addition, because investigators have to specify in advance what exactly they will be measuring, trial registration supports research integrity by discouraging post hoc statistical shenanigans and evidence distortion.
While there are various rules and regulations around trial registration, no other country currently enforces these nationwide.
HOW WILL THE UK SYSTEM WORK?
The UK system will launch in 2022 in partnership with ISRCTN, a London-based registry that already forms part of the WHO’s network of globally recognised trial registries.
The Health Research Authority is the UK ethics regulator that oversees all ethics committees in the country. It already centrally archives all ethics approvals for new clinical trials. Going forward, registrations will be performed centrally based on those documents.
Importantly, the new system will reduce red tape for medical researchers because they will no longer be required to register trials themselves. There will be no financial cost to researchers. In addition, the centralised approach seems likely to ensure consistently high quality of registration data.
The system will initially only cover drugs trials, and then be rolled out to cover all interventional clinical trials. It will cover both industry and non-commercial trials. Pharma companies and medical device manufacturers will continue to be offered the option to defer publication of full details for reasons of commercial sensitivity.
Update 22 October:
Two patients enquired what the industry "option to defer publication of full details" means in practice. TranspariMED asked HRA to explain, here HRA's response:
"The HRA has a policy for handling requests to defer publication about trials for reasons of commercial sensitivity and the new partnership doesn’t change this. We encourage sponsors to request to defer only in exceptional circumstances, and consider requests on a case by case basis. If deferral is agreed, we still publish a minimum data set about the research in question so that other researchers can see that it is underway. We also request that studies are registered on a publicly-accessible register at the end of the deferral period. When the automated registration starts we will request that where deferral is agreed, studies also publish a minimum data set on a publicly-accessible register before the study starts."
UK NATIONAL TRANSPARENCY STRATEGY
The new trial registration system forms part of the wider UK national Make it Public strategy, which aims to ensure that every single clinical trial run in the UK is registered and makes its results public.
The strategy was developed in the wake of a 2018-2019 parliamentary enquiry into clinical trial transparency, drawing on 700 consultation inputs by industry, academia, research funders, NGOs, and patients.
HUGE STEP FORWARD FOR TRANSPARENCY
Juliet Tizzard, Director of Policy and Partnerships at the HRA, said:
“Registering trials reduces research waste. It prevents duplication and means that more people can find out about studies to join."
"By automatically registering trials we’re making transparency easy for sponsors and researchers and saving them time. Trusted information about health and social care studies should be publicly available for the benefit of all."
Marc Taylor, Chair of the ISRCTN registry, said:
“Our collaboration will make registration and reporting of results easy and quick, leading the way to make transparency the norm in research. Our registry shares each study record with the WHO’s clinical trials portal.”
Till Bruckner, founder of TranspariMED, said:
“This is a huge step forward for clinical trial transparency not only in the UK, but worldwide. In future, when regulators claim that they cannot do anything about unregistered clinical trials, patients can point to the UK as evidence that where there is a will, there is a way.”
“Regulators worldwide should adopt this model in order to boost trial recruitment, accelerate medical progress, and protect patient interests.”
The Health Research Authority has announced that it will produce detailed guidance on the system in the near future. It will engage directly with networks to offer support.