Dear Editor
The call for “proportional representation of all ethnic groups in clinical trials” is, at best, naïve (1,2).
Clinical trials aim to establish causal relationships through strict selection criteria. Inclusion and exclusion criteria are designed to optimize study success and minimize bias. Mandating representation based on cultural traits—such as language, religion, or diet—complicates recruitment, increases type II error risk, and introduces poorly defined variables.
Calls for “inclusive” research prioritize ideology over scientific rigour. Pivotal trials already face major challenges, including reproducibility issues. Adding arbitrary barriers undermines their primary goal: experimentation, not real-life representation. These trials serve as prerequisites for drug approval, not reflections of population diversity. Regulatory agencies should focus on translational medicine—bridging experimental settings with real-world applications—rather than enforcing artificial inclusivity. Of note, subgroup analyses from clinical trials are often unreliable and should remain hypothesis-generating.”(3) In contrast, observational studies, using comprehensive national healthcare databases like those in Nordic countries or France, are better suited for assessing real-world benefits and harms. Pre-registering hypotheses, study designs, and analytical plans—through platforms like Open Science Framework— should be the mandatory norm in observational research to ensure scientific integrity.(4,5)
References
1. Anand SS, Arbour L, Ogilvie GS, Tita ATN. Inclusive research: a path to equity and better outcomes. BMJ. 2025;388:e082486. Published 2025 Mar 11. doi:10.1136/bmj-2024-082486
2. Anand SS, Bosch J, Mehran R, Mehta SR, Patel MR. Designing inclusive clinical trials: how researchers can drive change to improve diversity. BMJ. 2025;388:e082485. Published 2025 Mar 11. doi:10.1136/bmj-2024-082485
3. Wallach JD, Sullivan PG, Trepanowski JF, Sainani KL, Steyerberg EW, Ioannidis JP. Evaluation of evidence of statistical support and corroboration of subgroup claims in randomized clinical trials. JAMA Intern Med. 2017;177(4):554-560. doi:10.1001/jamainternmed.2016.9125
4. Braillon A, Naudet F. STROBE and pre-registration of observational studies. BMJ. 2023;380:90. Published 2023 Jan 18. doi:10.1136/bmj.p90
5. Naudet F, Patel CJ, DeVito NJ, et al. Improving the transparency and reliability of observational studies through registration. BMJ. 2024;384:e076123. Published 2024 Jan 9. doi:10.1136/bmj-2023-076123
Competing interests: I'm an old geezer from Northern France with variable practices.
Re: NHS England: divorced, beheaded, died
Dear Editor,
Congratulations on being one of the few commentators to correctly state that NHS Commissioning Board was formed by the Lansley reforms. The organisation was unhappy with being only first amongst equals with clinical commissioning groups at a local level.
Simon Stevens' well connected endeavours rapidly promoted NHSCB with the alias NHS England. And the major point of the reforms was conceded. This name only became official in 2022 at the same time as ICBs came in to being, see the first section of the 2022 NHS act. During the brief 3 year history of NHS England, it has not been as effective as its predecessor organisation. Whilst promoting the 2022 Act I asked the CEO if structural reform of CCGs was needed and she said that the structures were less important than the functions. However the structural reforms do damage the functioning of the organisation taking from four to 10 years to recover. During this time it is likely that large hospital trusts will successfully consolidate their control of local systems and their power will reconstruct the carefully constructed integration between multiple organisations developing along the lines laid out in 2016.
Without an alternative and compelling narrative as to future function, control is most likely to be determined by financial flows rather than population need, public health design or clinical requirements.
Competing interests: No competing interests