Delegates at the World Health Assembly today approved a resolution that aims to improve the coordination, design, and conduct of clinical trials worldwide, and calls on countries to ensure that publicly funded trials make their results public on a trial registry within 12 months.
UPDATE Friday 27 May: The resolution was formally adopted this morning..
UPDATE Sunday 11 June: Added quote from UK government press release
The World Health Assembly is the decision-making body of the WHO. Every year, it brings together diplomats from all WHO member states in Geneva to determine WHO policies.
In a press release, the UK government, which co-sponsored the resolution, noted that:
"There will... be closer collaboration between researchers on clinical trials across the world – reducing research waste – while increased transparency will mean the results of trials will be more readily shared between countries."
"The resolution aims to strengthen clinical trials of all health interventions, not just drugs and vaccines. For example, trials for new diagnostics, surgical procedures, or behavioural interventions."
Report trial results within 12 months
Globally, around half of clinical trials never make their results public, and thus make no contribution to advancing science or improving patient care.
The resolution thus encourages research funding agencies to promote:
“measures to facilitate the timely reporting of both positive and negative interpretable clinical trial results in alignment with the WHO joint statement on public disclosure of results from clinical trials and the WHO joint statement on transparency and data integrity, including through registering the results on a publicly available clinical trial registry within the [global trial registry network] ICTRP, and encouraging timely publication of the trial results preferably in an open-access publication.”
This statement officially enshrines the 12 month reporting timeframe for clinical trial results set out by the 2017 WHO joint statement on public disclosure of results from clinical trials, and specifies that results should be made public on trial registries as well as in academic journals.
Existing laws in Europe and the United States already require some trials to publish results on a registry within 12 months. However, these laws currently only cover a small minority of trials.
At present, it typically takes two to three years after a clinical trial has been completed until its results are made public. Reducing the timeframe to one year could help to significantly accelerate medical progress.
Registries uniquely enable researchers to meet this timeframe while also providing basic quality assurance safeguards.
During public health emergencies, the resolution recommends that funders should additionally encourage rapid results sharing through pre-prints.
Mandatory clinical trial registration
The resolution exhorts funding bodies to:
“introduce[e] grant conditions for funding clinical trials to encourage the use of standardized data protocols where available and appropriate and to mandate registration in a publicly available clinical trial registry.”
Stop funding shoddy trials
The resolution also tackles research waste head on in other areas.
It calls for the strengthening of national clinical trial capabilities and policy frameworks, and the alignment of research agendas with public health needs.
The resolution calls on countries to encourage research funding agencies to:
“prioritise and fund clinical trials that are well-designed and well-implemented, conducted in diverse settings and include all major population groups the intervention is intended to benefit, have adequate statistical power, and relevant control groups and interventions in order to generate the scientifically robust and actionable evidence needed to inform public health policy, regulatory decisions, and medical practice while preventing underpowered, poorly-designed clinical trials and avoiding the exposure of clinical trials participants to unjustified and unnecessary risk”
Trade publication Pink Sheet commented that:
"This recommendation draws on the frustrations faced by multinational companies during the early days of the COVID-19 pandemic, when they found it difficult to run large Phase III trials as they found themselves competing with 'tens of thousands of tiny studies'."
Today’s resolution lacks a passage highlighting the need to adequately fund clinical trial registries and the global ICTRP registry hub.
Perennial underfunding of the antiquated global registry system contributed to Covid research waste, and continues to undermine efforts to coordinate research and improve patient care across all areas of medicine.
It also fails to flag clinical trials of non-pharmaceutical interventions (NPIs) such as school closures, the lack of which undermined effective Covid responses worldwide. However, the resolution’s definition of clinical trial clearly includes interventional studies of NPIs.
Finally, the resolution does not mention transparency on the costs of clinical trials, which some access to medicines groups had called for in the run-up of the assembly, arguing that transparency of R&D costs could help to lower drug costs.
Surprise: Clinical Study Reports
A major surprise is that the resolution cites the 2021 WHO-ICRMA joint statement on transparency and data integrity, which calls for broad access to Clinical Study Reports, stating that “only personal data and individual patient data should be redacted.”
The pharma industry and U.S. diplomats have consistently opposed greater transparency in this area, so it is surprising that a reference to this document survived the negotiating process in Geneva. Health Canada is currently the only regulator to routinely make Clinical Study Reports available. The European Medicine Agency’s disclosure programme has been suspended since 2018.
What happens next?
The resolution requests the WHO Secretary-General to:
Organise stakeholder consultations to identify and propose measures to strengthen the global clinical trials ecosystem
Develop new guidance on best practices for clinical trials, both for national governments and for non-state actors
To present a “report outlining progress” on these items one year from now
This appears to be a watering down of the original draft of the proposal, which had called for the WHO to develop an “action plan”.
Going forward, TranspariMED will actively engage with the WHO’s stakeholder consultation process.
Till Bruckner, founder of TranspariMED, said:
“This resolution shows that governments worldwide have finally woken up to the immense human and financial cost of research waste in medicine. Patients should be able to trust that every single clinical trial result will be made public as rapidly as possible.”
“We will continue to push politicians and public research funders to ensure that all clinical trial results are made public on trial registries within 12 months, so that no trial is left behind.”
A study assessing the clinical trial policies and research waste safeguards of major European funders will be published over the coming weeks. A separate study covering major U.S. funders will be published in late 2022.
The World Health Assembly clinical trial resolution was originally co-sponsored by Argentina and the UK. (This blog will be updated with the final list of co-sponsors and voting results.)
The UK gained a lot of attention during the pandemic due to its excellent Covid clinical research programme, which avoided the ‘research chaos’ and research waste common in other countries.
In the run-up to WHA75, major non-profit research groups including Gates Foundation, CEPI and DNDi strongly supported the resolution.
Following the approval of the resolution, Anthony McDonnell from the Center for Global Development commented that it was a "positive step" but did not go far enough.