APBI calls for greater participant diversity in industry studies
15 June 2025. Related: Early access, Special reports, Research studies.
Simon Collins, HIV i-Base
A new publication from the Association of the British Pharmaceutical Industry (APBI) and the Association of Medical Research Charities (AMRC) outlines proposals for a more equitable basis for enrolment into clinical research studies. [1]
This is a report from a stakeholder workshop earlier this year that included community, research and industry perspectives on improving diversity in clinical research. The focus on diversity in the UK is essential given the attempts by the current US administration to reverse years of progress by cancelling Diversity, Equity and Inclusion (DEI) policies since 20 January. [2]
Many of the barriers to greater equity have been raised by community organisations for decades, including social, political, economic, educational and practical issues. Greater inclusivity would generate study results in people who more closely reflect the characteristics of the population likely to use new drugs once they are approved. [3]
One proposal from the meeting is to develop a roadmap for the future with action points that include improving diversity in research studies, building trust with community groups and to change restrictive regulations, also working with appropriate regulatory organisations.
However, the report also refers to ‘seamlessly integrating patient input into every stage of a drug’s lifecycle – from initial research and development through clinical trials, regulatory approval and commercialisation’.
However the APBI’s own Code of Practice is interpreted by some drug companies to exclude discussions about their HIV treatment or prevention drugs or drug pipeline with community organisations, including the UK Community Advisory Board (UK-CAB).
These guidelines also have a very restricted definition of health professionals that fails to include community advocates.
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It is encouraging that the proposals provide leadership guidance, but change really depends on whether the 70+ companies that are APBI members put these ideas into practice.
Perhaps including some of these ideas in the APBI Code of Practice might help.
For example, HIV is still a common exclusion criteria for new drugs – from cancer to the latest GLP-1 agonists and APBI could support broader inclusion criteria to allow for common unrelated chronic comorbidities.
Also, although this report refers to low literacy being a barrier to equitable participation in the more than 400 industry studies in the UK each year, it didn’t directly mention that participant information for industry studies is still produced at literacy levels that are much too high for the general population. [4, 5]
If APBI members were to agree with NHS recommendations for participant information to have a target reading age of 11-12 (roughly Flesch Reading Ease score >70 and Flesch-Kincaid Reading Grade 7 or lower), this change could happen overnight.
An excellent recent review of inequity in health care was published by the senior HIV consultant Dr Rageshri Dhairyawan. [6]
References
- APBI and AMRC. Achieving inclusivity in clinical research. (12 June 2025).
https://www.abpi.org.uk/publications/achieving-inclusivity-in-clinical-research/ - US White House. Ending Radical And Wasteful Government DEI Programs And Preferencing. )20 January 2025).
www.whitehouse.gov/presidential-actions/2025/01/ending-radical-and-wasteful-government-dei-programs-and-preferencing/ - Barr L Jefferys R. A landscape analysis of HIV cure-related clinical trials and observational studies in 2018. J Virus Erad. 2019 Nov 45(4):212-219. doi: 10.1016/S2055-6640(20)30030-3.
https://pmc.ncbi.nlm.nih.gov/articles/PMC6844401/ - Are patient information leaflets for research studies too difficult to read? 21st Annual BHIVA Spring Conference, April 2015, Brighton. Oral abstract O4.
https://www.youtube.com/watch?v=AyCgPGII3Js&t=5s - Fischer AE et al. The readability of informed consent forms for research studies conducted in South Africa. South African Medical Journal, 3(2) Sept 5 2022.
https://www.ajol.info/index.php/samj/article/view/231280 - Dhairyawan R. Unheard: the medical practoce of silencing.
https://i-base.info/htb/49299