Can WHO’s new trials guidance challenge a lack of inclusivity in research?
BMJ 2025; 388 doi: https://doi.org/10.1136/bmj.q2873 (Published 12 February 2025) Cite this as: BMJ 2025;388:q2873- Anna Volkmer, media fellow
- The BMJ
- a.volkmer.15@ucl.ac.uk
During the covid-19 pandemic the UK revolutionised clinical trial delivery. In a combined effort to find a vaccine against the then new virus, government, academia, and the industry came together with the National Institute for Health and Care Research (NIHR) and the newly established vaccine taskforce working with the NHS to recruit 500 000 volunteers for 14 covid-19 vaccine trials by June 2021.1
This culminated in what the former health minister James O’Shaughnessy described, in his government commissioned review of UK commercial clinical trials, as “one of the most successful vaccine roll outs globally” when the Pfizer, Moderna, and AstraZeneca covid jabs were distributed in 2021.2
Yet O’Shaughnessy’s review also identified major problems with trial delivery in the UK and around the world. For one, although the centralised nature of the NHS has been cited as a benefit, O’Shaughnessy found it also to be a major barrier, with a lack of incentives for doctors, nurses, and other NHS staff to take part. Even when monetary incentives were offered, these were often not invoiced for and therefore not received. The review said that this showed a lack of value placed on trial participation.
Such issues were echoed in September 2024 when the World Health Organization published new guidance on best practices in clinical trials,3 calling for increased inclusion of high risk participants and more countries in each study.
High income versus low income countries
WHO raised a concern that trials exclude low and middle income countries. In 2022 there were more trials taking place in the world’s high income countries (27 133 trials) than in low and middle income countries (24 …
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