Recent developments in the United States, where the Food and Drug Administration (FDA) has withdrawn guidance encouraging diverse representation in clinical trials, raise significant concerns about the future of research equity. Ensuring that medicines and medical devices are trialled in representative populations is essential to generating findings that are applicable to all members of society and enabling equitable access to effective treatments (1)
The UK has a strong track record in promoting inclusivity in research. Joint guidance is currently being developed by the Health Research Authority and the Medicines and Healthcare products Regulatory Agency to reinforce the importance of diverse participation in clinical trials (2).
Without ensuring equitable and representative research, we risk missing crucial insights into how treatments affect different populations and ancestral groups (3), including variations in response to medicines and medical devices (4). There are now calls to increase ethnic inclusivity in child health and young people’s research, underlining the need for action to ensure equity across all age groups and demographics (5).
Equally, there have been too many instances in the past where serious side effects in specific populations were missed until after products were licensed for use. This is due to exclusion of certain groups from clinical trials.
Pharmacists in the UK play a pivotal role in ensuring the safe and effective use of medicines. As key healthcare professionals, they must act as allies in safeguarding and advancing inclusivity in research. A retreat from this critical practice would have untenable consequences for the UK’s diverse population.
We strongly advocate for the principles of:
- Inclusivity throughout clinical trials processes
- Equity in access to clinical research
- Diversity of trial participants representing underserved communities
- Active commitment to ensure that evidence through research is generalisable to all members of the population we serve.
Ensuring research reflects the diversity of the population is fundamental to delivering better, safer, and more effective healthcare for everyone.
References
- Executive order from the White House. Accessed from Fact Sheet: President Donald J. Trump Protects Civil Rights and Merit-Based Opportunity by Ending Illegal DEI – The White House on 25th January 2025
- Increasing the diversity of people taking part in research. Accessed from Increasing the diversity of people taking part in research – Health Research Authority on 25th Jan 2025
- Magavern, E, Jacobs, B, Warren, H. et al. CYP2C19 Genotype Prevalence and Association With Recurrent Myocardial Infarction in British–South Asians Treated With Clopidogrel. JACC Adv. 2023 Sep, 2 (7) . https://doi.org/10.1016/j.jacadv.2023.100573
- Crooks CJ, West J, Morling JR, Simmonds M, Juurlink I, Briggs S, Cruickshank S, Hammond-Pears S, Shaw D, Card TR, Fogarty AW. Differential pulse oximetry readings between ethnic groups and delayed transfer to intensive care units. QJM. 2023 Feb 14;116(1):63-67. doi: 10.1093/qjmed/hcac218. PMID: 36066450; PMCID: PMC9928225.
- Time to address ethnic inclusivity in children & young People’s research. K, Babla et al. eClinicalMedicine, Volume 37, 100973