Despite a step change in awareness about the need for diverse participants in clinical trials, ongoing clinical trials in western health systems fail to reflect real world diversity. Whilst much has been written on the challenges and strategies for engaging diverse ethnic groups there has been less of a focus on engaging and enabling diverse healthcare institutions.
Less than a quarter of healthcare institutions in the US participate in commercially funded clinical trials. For treatments that truly meet the needs of diverse populations, it is vital to expand the reach beyond the well-funded central healthcare institutions – which tend to be most accessible to wealthy, predominantly white populations1 – to include smaller, local providers. These local clinics are often located in those areas that are historically underserved and can serve as a gateway to underrepresented, less wealthy communities and populations with greater ethnic and racial diversity.
Fixing the diversity problem in clinical trials will not be possible if the focus remains squarely on increasing participation at existing trial site populations. To ensure that clinical trials reflect real-world diversity, it is essential that we support smaller organizations to overcome their challenges to participation.
A question of trust
Mistrust is one of the biggest barriers to clinical trial participation for diverse groups. 40% of ethnic minorities2 do not trust the healthcare system, and in a Research America survey3, half of Black respondents and 42% of Hispanic respondents spoke about a specific mistrust of medical research.
Physician trust is absolutely crucial to ensure active participation in research. Encouragingly, it appears that participation in clinical trials can be increased if people are recommended by their personal physician4 or if the health professional and the patient have a shared ethnic background5. Enabling local clinics to participate in clinical trials would therefore be a highly effective way of building trust and increasing participation among underrepresented groups.
Current resourcing challenges prevent local providers from joining the diversity push
Some companies are already working on a decentralized approach, increasing diversity in clinical trials by employing frontier sites6 – such as pharmacies and community clinics — that are embedded within the community. However, there is a downside – participating healthcare professionals are required to commit more time to research, which often comes at the expense of patient care.
The issue of resourcing has always been a significant barrier for smaller healthcare providers. Patient recruitment has historically been reliant on time-intensive processes such as manually going through individual electronic health records (EHR) to identify suitable patients. While burdensome for large health centers, this presents an often-insurmountable challenge for under-resourced, local practices, who are already over-stretched delivering to their number one priority – patient care. Becoming a successful, revenue-generating research center often demands additional staffing resource to enable cohort recruitment, ongoing patient communication and the effective running of research – all of which requires financial investment and a level of business risk.
But post-Covid healthcare providers across the board are facing challenges. Even large centers are struggling to procure and fund resources in an employment market place where personal priorities have shifted and there is a greater desire for flexible working. The American Society of Hematology (ASH)7 has written about the impact of these challenges on hematology and oncology research highlighting a U.S. Bureau of Labor Statistics8 report that revealed a record 4.5 million workers quit or changed jobs in November 2021, with health care and social assistance among the industries with the largest increases in turnover. ASH suggests that greater flexibility and higher salaries could also be the driver behind the boom in registered nurses leaving to join the travel nurse industry, forcing centers to fill gaps by hiring back the very nurses they have lost, at vastly increased rates.
Introducing technology that pays for itself
The challenge is how to work with all centers to remove some of the organizational burden of clinical trials and to embed recruitment in routine practice. For example, emerging patient recruitment technologies — sometimes called automated recruitment platforms (ARPs)– achieve this by rapidly finding and engaging suitable patients from within existing databases, simplifying the consent process and collecting prospective data to answer key clinical questions.
This enables providers to participate in research without fundamentally changing their business model or building a research infrastructure of additional staff, regulatory support or IT systems. ARPs can help even the smallest healthcare providers to participate in revenue-generating research, enabling them to build research evidence in days rather than months or years.
Beyond ARP’s, new technologies are going further to reduce the burden of collection of patient-generated data at home and linkage to clinical data in the patient’s Electronic Medical Record (EMR). This allows physicians to passively participate in research, re-focus resources to patient care and access unique insights on their own patient population.
Bespoke, automated outreach
Technology is also enabling healthcare providers of all sizes to move away from standardized patient outreach in clinical trials to individually tailored communications. By using the EHR to segment cohorts into different subgroups, patients can be targeted with bespoke messages or visuals, which has been shown to increase participation of underrepresented groups.
This has been used to good effect in the Predict-PD Parkinson’s study where eligible participants, identifying as from an ethnic minority, were targeted with images of ethnically diverse patients in study communications. Tailoring communications in this way resulted in an increase in the proportion of participants coming from a minority background from 3% to 18%, providing better, more generalizable results for the study team at Queen Mary’s University of London (uMed data on file).
Language is another obvious but often overlooked factor. While more than one in ten people in the U.S speak Spanish at home, increasing numbers9 of clinical trials exclude patients who aren’t fluent in English. The 2022 American Association for Cancer Research, Disparities Progress Report10 found that Hispanic people represented only 3% of participants in clinical trials, despite making up 18% of the U.S. population. Translation costs may previously have been prohibitive but new technologies are helping to circumvent this challenge by enabling patient communications to be automatically shared in different languages.
Democratizing research
Persisting with our current, centralized approach to clinical trials will perpetuate a health system that predominantly serves white, middle-class people, which will in turn add to the distrust amongst other groups.
This situation has to change now, before it gets worse. This can only be done through the better use of technology that empowers local clinics to participate – both easily and profitably – in clinical trials.
About the author
Dr Matt Wilson, CEO & Founder uMed, is a physician by background, having received a distinction in his medical degree from Cardiff University. As a military sponsored undergraduate, he went on to complete his junior doctor years at Derriford Hospital in Plymouth and it was then he developed an interest in clinical research, supporting studies evaluating the use of thromboelastography in pancreatitis.
After three years working as a Royal Navy Medical Officer, he earned his green beret to work as a doctor in the Royal Marines. This time included a range of operations and exercises across the Middle East, Somalia, Kenya, Albania and Norway.
Moving back to work within the NHS, Matt then worked in emergency medicine before entering specialist training in anaesthetics. He founded uMed in 2017 recognising the opportunity to automate key parts of the clinical study process by using electronic health record data. Matt is also a fellow of the NHS Clinical Entrepreneur Programme.
References
1 https://florencehc.com/blog-post/how-community-sites-can-improve-the-lack-of-diversity-in-clinical-trials/
2 https://www.brookings.edu/articles/discrimination-in-the-healthcare-system-is-leading-to-vaccination-hesitancy/
3 https://florencehc.com/blog-post/how-to-improve-patient-diversity-in-clinical-trials/
4https://florencehc.com/blog-post/how-to-improve-patient-diversity-in-clinical-trials/
5 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6092744/
6 https://javararesearch.com/wp-content/uploads/2021/05/White-Paper_Achieving-Diversity-in-Clinical-Trials-1.pdf
7 https://ashpublications.org/ashclinicalnews/news/6220/Help-Wanted-Research-Edition
8 https://www.bls.gov/opub/ted/2022/number-of-quits-at-all-time-high-in-november-2021.htm
9 https://florencehc.com/blog-post/how-to-improve-patient-diversity-in-clinical-trials/
10 https://cancerprogressreport.aacr.org/disparities/cdpr22-contents/cdpr22-disparities-in-clinical-research-and-cancer-treatment/#trialdisp
