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What to make of UK’s draft resolution set for review on the international stage.
At the beginning of April, discussions are due to start in Geneva on a proposal from the UK to "strengthen clinical trials to improve public health" at the international level. The initiative comes at a curious moment insofar as the UK has chosen to isolate itself from its principal European partners for the last half-century by withdrawing from the European Union, where it had played a significantly influential role in the development of clinical trials regulation. By putting forward this proposal for consideration at next May's World Health Assembly, where World Health Organization policy is decided, it is clearly profiling itself as still a driving force in global regulation—and its recognized success with large-scale trials, such as the RECOVERY trial that demonstrated its value during the COVID-19 pandemic, certainly gives its bid a certain status.
The draft resolution goes through the customary preamble of acknowledging WHO's role and responsibilities in health research and the importance of high-quality research and knowledge generation in achieving health-related development goals, and gives a firm endorsement to the concept of randomized controlled trials "as a cornerstone of high-quality healthcare." It also puts in a slightly odd plug for quality clinical trials as a factor in "equitable access to healthcare interventions," and a more easily understood recognition of the importance of trials in responding to public health threats nationally, regionally, and globally—with specific reference to the pandemic.
The meat of the proposal, however, is a call to WHO member states to up their game in promoting the quality of trials and the capacity to conduct them, with a passing dig at the way it believes that the current variation in clinical trial standards "impacts the quality of evidence available to inform the development of healthcare interventions." So, the UK notes "the urgent need to enhance international clinical trial capability" and to ensure "robust clinical trial standards in routine practice."
The standards it urges include ensuring trials are of sufficient size and developed in collaboration with affected communities, using standard data protocols, mandatory registration on a clinical trial registry, and pre-publication sharing of results with regulatory bodies and other public health authorities, as well as "timely" publication of results at end trial completion. It also insists on the importance of ensuring trial data—whether demonstrating positive, negative, or no overall effect—are considered and acted upon rapidly by regulators.
The proposal also carries an implicit warning about poorly-deployed financial support for trials: it is important, it says, that collaboration and coordination between public and non-public funders of clinical trials should "help ensure funding is targeted toward quality clinical trials that will produce actionable evidence, and which aim to address issues of public health importance."
The text is clearly aimed at the poorer countries in WHO membership. Everyone should be playing a role in increasing clinical trial capability globally, particularly in developing and low-and-middle-income countries, it says. The mechanisms should be to enable a greater number of clinical trials sites and better coordination through "existing and new clinical trial networks"—although it does not specify which. Measures should also be taken to improve information sharing on innovative and efficient clinical trial design and delivery. This will, it says, help researchers conduct effective trials, and help funders make "informed decisions based on methodological rigor."
The UK is also keen to establish a ranking of what it suggests is the right sort of trial activity. WHO member states should "coordinate research priorities in order to align and prioritize clinical trials when mutually beneficial and to avoid duplication, helping to ensure public and private resources are effectively deployed where they are needed. They should also "collaborate with private sector funders and academic institutions to ensure that clinical trials are targeted toward the development of interventions that tackle communicable and non-communicable diseases of global, regional, and national importance."
The proposal has been broadly welcomed by TranspariMED, the civil society organization that has played a prominent role in recent years in pressing for publication of trials results. It says the proposal could help remedy some of the errors in the early stages of the COVID pandemic which were characterzsed, it says, "by “research chaos” in which hundreds of badly designed and underpowered clinical trials were launched"—and "the vast majority of those trials were a complete waste of resources, and did nothing to advance science or improve patient care." But TranspariMED regrets the lack of a fixed deadline for post-trial reporting, and the absence of insistence on funding for trial registries, some of which are "riddled with out of date and inconsistent data." It sees the resolution as a useful contribution to momentum for better standards worldwide.