UK proposes global effort to strengthen clinical trial transparency
The UK will propose steps to improve clinical trial quality and transparency at the 75th World Health Assembly, a document posted online shows.
What does the UK propose?
The draft UK resolution urges countries worldwide to take the following steps:
Clinical trial design. “Ensuring new trials are not duplicative, are of sufficient size and appropriate design”
Trial registration. “Introducing grant conditions for funding clinical trials… to mandate registration on a clinical trial registry”
Results reporting. “Establishing mechanisms to ensure the results of clinical trials are reported in a timely manner following primary study completion, including through registering the results on a clinical trial registry within the [global trial registry network] ICTRP, and encouraging timely publication of the trial results ideally in an open-access publication”
In addition, the draft requests the Director General of the WHO to develop a global action plan for implementing these principles and presenting that action plan for consideration by the 76th World Health Assembly in 2023.
Trial design. The early stages of the Covid pandemic were characterised by ‘research chaos’ in which hundreds of badly designed and underpowered clinical trials were launched. It has since become clear that the vast majority of those trials were a complete waste of resources, and did nothing to advance science or improve patient care. Against this sorry backdrop, the UK’s coordinated approach has made it a beacon of pandemic research excellence (exemplified by the widely acclaimed RECOVERY trial). Many other countries are already studying the successful UK approach.
Trial registration. All major UK funders already require clinical trials to be registered. Many other funders worldwide pledged to do so in 2017, but some have yet to deliver on that promise [publication forthcoming]. Requiring trials to be registered should be a no-brainer, and hopefully the proposed resolution will renew momentum on this important issue.
Results reporting. Around half of all clinical trials never make their results public, contributing to an estimated annual $85 billion in avoidable medical research waste due to non-reporting. The UK is likely to soon introduce national legislation requiring every single interventional clinical trial to make its results public, and actively monitor compliance, thereby becoming the first country worldwide to finally put an end to this decades-old problem. The proposed resolution will hopefully encourage other countries to follow the UK’s positive example. A weakness is that the resolution does not cite the 12 month reporting timeframe recommended by the WHO.
Missing: Funding for trial registries. The only downside is that the resolution fails to encourage countries to step up funding for clinical trial registries. The WHO-run global ICTRP database of all clinical trials relies on data from 17 separate trial registries plus the American ClinicalTrials.gov registry. Some of these registries are desperately underfunded and lack basic features and quality safeguards, leaving them riddled with out of date and inconsistent data. ICTRP itself is also underfunded and promptly crashed in the early days of the pandemic, undermining the ability of medical experts worldwide rapidly check who was already researching which drugs. While the cost of adequately funding trial registries would be negligible, improved coordination of global research efforts – both during pandemics and in normal times – will require that money to somehow be found.
In sum, this draft resolution could generate global momentum to improve clinical trials and curb rampant research waste, which would significantly benefit patients worldwide.
The full text of the UK draft resolution can be downloaded below:
The WHO already recommends that “Legislation or supporting regulations [should include] sanctions if a clinical trial is not registered and/or results are not reported.”
However, existing legal reporting requirements in the US, the EU and the UK are largely ineffective because they only cover a minority of all trials and are not being effectively enforced.
The UK had already pushed for better global clinical trial coordination and improvements in trial quality during a 2021 meeting of G7 health ministers. The “G7 Therapeutics and Vaccines Clinical Trials Charter” set out measures that G7 governments could take to “avoid the proliferation of trials that do not contribute to valid or actionable scientific evidence”. However, the G7 paper did not address trial registration or results reporting.
The current World Health Assembly initiative is led by the Permanent Representative of the UK to the WTO and UN in Geneva.
For an explanation of how weak clinical trial transparency harms the poor and undermines global health and the Sustainable Development Goals, see this policy paper by the U4 Anti-Corruption Resource Center.
For more details on the benefits of clinical trial transparency and applicable global standards and best practices, see this briefing for policy makers by Transparency International, Cochrane and TranspariMED.