The UK is poised to become the first country worldwide to ensure that all clinical trials are registered and report their results, with clinical trials being registered centrally and a government agency monitoring whether their results have been made public.
A new national strategy released by the UK’s Health Research Authority comes in response to sustained campaigning by patient, transparency and health groups including TranspariMED, Cochrane, Universities Allied for Essential Medicines and AllTrials, and a 2018-2019 parliamentary enquiry into unreported clinical trials that found evidence of widespread research waste at UK universities and within the National Health System.
The ambitious long-term strategy seeks to “make transparency easy, make transparency the norm, and make information public”. Importantly, the strategy aims to deliver transparency while at the same time reducing red tape for researchers.
The strategy covers all interventional clinical trials, including trials of medicines, medical devices, surgical techniques, public health measures, and behavioural therapies (summary below).
In this short video, the Health Research Authority’s Juliet Tizzard explains how the Covid-19 pandemic has further highlighted the need for transparency and rapid results reporting in medical research: “We need to get access to the results of those research projects as quickly as possible so that we can change clinical practice and to improve the care that we offer”.
For more details on the strategy, see further below.
Dr Karla Soares-Weiser, Editor in Chief of the Cochrane Library, said:
“The new HRA strategy sets out to be a key part of the push towards 100% trial transparency in the UK, where we have seen great improvements in the registration and reporting of clinical trials in recent years."
"This overall progress demonstrates to other countries that it is possible to vastly increase transparency. We hope that decision makers around the world are taking note and will implement measures to improve registration and reporting rates in their countries. If we are unable to get a full view of the research evidence, we cannot make truly evidence-informed decisions about healthcare.”
Rachel Cooper, head of the Transparency International Health Initiative, said:
"Transparency International Health Initiative welcomes the UK’s new Make It Public strategy. As our Clinical Trial Transparency report made clear, transparency in research has both fiscal and health impacts. Resources are wasted further developing, and then purchasing a medical technology that is potentially ineffective and might even be unsafe. In addition, it slows scientific progress and leads to research waste if other researchers are unable to obtain full trial or study data in order to replicate, confirm and build upon research findings."
"The devil will be in the detail of implementation and how the HRA measures transparency and addresses non-compliance. But the strategy sends a positive message that the UK takes research transparency seriously. We hope other countries will follow this example."
Till Bruckner, founder of TranspariMED, said:
“This is a big step forwards for patients and taxpayers in the UK, and further cements the UK’s global reputation as a hub of excellence in clinical research. It is hardly a coincidence that the country running the world’s most closely watched Covid-19 clinical trial is also the frontrunner in medical research transparency."
"The Health Research Authority has clearly demonstrated that where there is a will, there is a way. In future, decision-makers in other countries, notably in continental Europe, can no longer argue that it is impossible to prevent research waste in clinical trials. TranspariMED welcomes the new strategy and will closely monitor its implementation to ensure that it fully delivers on its promises.”
Below some key takeaways from the strategy:
In future, the Health Research Authority (HRA) will itself directly register clinical trials based on data submitted during the ethics approval process, which it already centrally archives.
This is a radical departure from common practice in other countries, where either individual researchers or institutions (such as universities or pharma companies) are expected to register trials themselves. Hopefully, the new system will resolve the pervasive problem of ‘invisible’ clinical trials once and for all – and improve the quality of trial registrations.
All clinical trials will be expected to report their results within 12 months, mirroring the time horizon set out by existing EU rules for drug trials, US legislation, and WHO best practices. In addition, the HRA will also require submission of ‘lay summaries’, i.e. summaries of trial results that non-experts can understand.
Brexit update: The UK medicines regulator MHRA has announced that post Brexit, UK drug trials will have to be registered on trial registries other than the European EudraCT. Sponsors will have to make trial results public on the registry (or registries) where the trial was originally registered within 12 months of trial completion. Thus, the UK will maintain existing EU transparency standards post Brexit.
Keeping trial registry entries up to date
The HRA will “take a more proactive approach to prompt sponsors and researchers of clinical trials to keep their study information up to date in registries.” At present, much of the data on trial registries is incomplete, contradictory, and out of date, creating numerous problems for patients, researchers, and health care systems. The new strategy aims to fix that.
Making sponsor performance visible
From 2021-2022 onwards, the HRA will regularly publish monitoring data enabling the public to see which pharmaceutical companies, universities, NHS Trusts and medical research charities are making results public as required – and which are not. This will increase public pressure on trial sponsors to play by the rules.
The HRA is already in discussions with public research funding agencies and other stakeholders to develop “a high-quality, interconnected research approvals system”. The aim is to cut down on red tape and deliver transparency by aligning ethics approval, oversight and reporting systems across public agencies, and harmonising transparency requirements across players.
In 2021-22, the HRA will “introduce research transparency performance assessment into review of new studies”. In other words, those who fail to meet transparency expectations may be refused ethics approval for future studies.
However, it is still unclear whether this sanctions mechanism will be applied to individual researchers or to institutions, and how. This falls short of the demands of TranspariMED and eleven allied groups including Cochrane and Transparency International Health, which had jointly called for the imposition of financial penalties on non-compliant trial sponsors (while opposing sanctions on individual researchers).
TranspariMED will closely monitor how the HRA implements the new sanctions, and – crucially – whether they are effective.
Details on key elements of the plan and their implementation have yet to be determined, including some key timelines (see the implementation plan). This is due not only to the pandemic, but also to uncertainty about the governance of drug trials in the UK post-Brexit, the complexities of aligning systems across multiple public agencies, and the need to develop detailed new policies, systems and processes against a backdrop of severe budgetary constraints. For example, the strategy leaves open whether the UK will set up a national clinical trial registry.
Implications for trial sponsors
The HRA will update and clarify its research transparency requirements by December 2020. However, sponsors need to start preparing now in order to meet the new transparency benchmarks. This includes adapting systems to ensure that the results of all interventional clinical trials (not only drug trials) are made public on a trial registry within 12 months of trial completion, and budgeting for registry reporting and lay summary production in applications for new funding grants.
Trial sponsors can use TranspariMED’s collection of transparency tools to strengthen their policies, systems and processes.
The strategy provides a useful blueprint for other countries seeking to reduce research waste and evidence distortion in medicine.
Download the full #MakeItPublic national strategy and share it with decision-makers in your own country.