Tackling the disparities in clinical trial access for better health equity

The World Health Organisation’s vision is for ‘everyone, everywhere to have an equal chance to live a healthy life’^[1]. However, despite these aspirations, we are a long way from realising them^[2][3][4][5].

As the innovators of therapies that alleviate the burden of disease and advance global health, biopharma has a responsibility to contribute towards improving health equity by ensuring all patients have access to safe and effective treatments.

Patient diversity in clinical trials is essential for achieving health equity. Older people, women, those who are disabled or identify as LGBTQ+ and people from lower socioeconomic backgrounds and ethnically and racially diverse populations are all typically underrepresented in clinical research^[6][7][8].

A lack of involvement in clinical research can have far-reaching implications with the resulting data gap potentially undermining the effectiveness of innovative medicines^[9][10].

How patient diversity can benefit your business, healthcare and patients themselves

Biopharma

• Researchers better understand the potential, and also the implications of, new therapies in diverse populations that are more reflective of modern day society^[11]
• A better understanding of and greater engagement with diverse patient populations will help to build trust among communities that are typically underrepresented in clinical trials
• A more robust and comprehensive body of evidence for market use
• All benefits link back to stronger opportunities to expand access to therapies for these diverse patient groups

Healthcare professionals (HCPs)

• Better product information to inform treatment decisions, including dosage, for different patient populations^[12]

Patients

• The opportunity to benefit from new and innovative treatments
• Underserved communities experience the full benefit of available treatment options & potential life-saving therapies

While the industry is taking steps towards increasing representation of marginalised populations in clinical trials^[13], the path is not always straightforward. Despite best intentions, there remains a significant need to intensify these efforts. We have identified five key areas to achieving greater patient diversity within your drug development pipeline, for the good of global health.

1. Get under the skin of the problem

Embed the practice of comprehensively recording and analysing full clinical trial patient population insights

The issue of patient diversity in clinical trials can only be tackled by recognising the scale of the issue. A comprehensive assessment of your current clinical trial recruitment and data recording practices can provide knowledge to inform:

• how trial recruitment is approached, and
• what needs to change so that efforts can be directed towards informing, attracting, and retaining more diverse patients.

Making a habit of recording and analysing insights on an ongoing basis will help to better understand who these underrepresented communities are and identify barriers for inclusion and areas for improvement. Digital and data insight capabilities can also help in setting recruitment ratios requiring diverse patient populations are adequately represented in clinical studies, and assessing how sites can be supported to achieve this.

2. Embed diversity into the DNA of patient-centricity

Deliver consistent and sustained patient-centric action to tackle the issue of mistrust

Patient centricity, by its very nature, is about providing all patients with a voice and equal access to healthcare services, treatments and technologies. Patient diversity is key to achieving your patient-centric visions.

However, there is a persistent lack of trust in the biopharma industry^[14], due in part to historic events such as the Syphilis Study in the US, as well as other barriers including language and communication, attitudes and beliefs, lack of knowledge of clinical trials and practical issues^[15].

Mistrust in the pharmaceutical industry must be tackled with a multi-pronged approach to:

• design clinical trials around all relevant patient populations, considering their needs and barriers to participation;
• engage directly with people from underrepresented communities – give them the space to speak freely and act on what they say; and
• utilise patient organisations to incorporate the patient voice into your work and develop sustained relationships centered around education.

3. Explore ways to make clinical trials more accessible to diverse communities

Build trust and engegement by communicating with diverse patient populations in their preferred spaces and language

Often, the best places to inform and speak to individuals may not be in healthcare establishments but more community-based venues, such as social clubs and church groups where they feel more relaxed and are more likely to meet individuals who are going through similar experiences.

Being prepared to listen and learn directly from underrepresented communities, especially those who hold most influence such as religious leaders or community physicians can help biopharma to build trust. Despite growing dependency on digital technology, traditional offline methods continue to be most effective in converting people into clinical trial participants^[16][17].

Consider that not everyone may have English as their first language. Ensure information is presented in the most appropriate language and format for each group of people.

Also think about your external networks for clinical trial recruitment. It can be easy to approach larger institutions to support patient enrolment but do they have access to the diverse patient population that you require?

Consider the location of clinical trial sites - many are typically based in more affluent areas, which can itself be a barrier to participation for underserved communities.

4. Be an ‘educator’ for patients and HCPs alike

Consider your role in educating patients and HCPs to tackle the potential for misinformation and ensure they understand what clinical research involves and the trials that are available

There is a lack of clinical trial awareness among patients and, to a degree, among HCPs.

For patients, this includes what clinical trials involve and the benefits of participating. For HCPs, the challenge is keeping up-to-date on relevant trials for the patients they serve.

Biopharma has the ability to provide greater education for patients, providing information in the most accessible language and format to help them understand why their participation in a clinical trial would be beneficial for them as well as their communities.

Meanwhile, consider transforming your HCP engagement to ensure they are equipped with the latest information, particularly those who care for underrepresented communities. Educate them about unconscious bias and its effects in hindering access to innovative healthcare. Challenge HCPs to think about the role of unconscious bias in the way they interact with patients, and how they can overcome this.

5. Acknowledge there is no ‘one size fits all’

Blend traditional and digital elements into clinical trials, and ensure appropriate support is available so that no-one is left behind

Don’t fall into the trap of thinking that something that works for one group of patients will work for another. For example, decentralised clinical trials (DCTs) grew in popularity during the pandemic, but this model wasn’t suitable for all and did not necessarily positively impact the patient experience^[18].

For some groups, home visits from a nurse can be stigmatising. Others may prefer a clinical setting for reassurance. And, despite the growing trend towards virtual clinical trials and the use of apps, devices and e-tools to monitor patients’ health, not everyone is online or will have access to these electronics^[19][20][21].

To ensure inclusivity in clinical trials, it is important to implement a variety of approaches to cater to the needs and preferences of different groups. This way, no one will be excluded from the opportunity to access innovative medicines through a clinical trial.

Consider a hybrid approach to clinical trials that blends traditional monitoring methods, such as in-person and site-based visits and tests, with more novel methods like the use of ediaries or apps. Equip your participants with the resources necessary to enable them to take advantage of all methods, if they so wish, eliminating obstacles to participation.

Offering a range of options allows biopharma to extend its reach within underrepresented communities while also improving the patient experience and engagement.

How Baringa can support diverse patient engagement

Health equity is a critical objective for global healthcare systems and organisations. Patient diversity in clinical trials plays a core role in achieving this goal and biopharma must take proactive measures to move closer towards the goal of better health outcomes for all by involving more diverse populations in clinical research.

Engaging with diverse patient populations and improving their access to quality healthcare can be a complex landscape to navigate. With Baringa’s expertise, we can support the mindset shift needed to drive change, and work with you to develop and implement the necessary actions to build trust and increase participation amongst underrepresented communities to deliver meaningful results and achieve profound impact in healthcare.

To find out more about how our expertise can unlock greater patient diversity in pharma R&D, please get in touch with Kate Moss, Chris Maxted and Laveshni Reddy.

Subscribe to our Pharmaceuticals and Life Sciences Reports to get industry news and trending topics direct to your inbox.

^[1] World Health Organization, About WHO (last accessed May 2023),  https://www.who.int/about

^[2] Marmot M, Allen J, Boyce T, Goldblatt P, Morrison J. Health Equity in England: The Marmot Review 10 Years On. Institute of Health Equity; 2020, https://www.health.org.uk/publications/reports/the-marmot-review-10-years-on

^[3] Michael Marmot, Antia Castedo, Michael Alexander, Jessica Allen, Peter Goldblatt, Jean Woo, Eng-Kiong Yeoh, Hung Wong, Roger Chung, Dexia Kong, Eric Lai, Gary Chung, Yat-Hang Chan, Richard Lee. Health Inequalities in Hong Kong: A Life Course Approach. Institute of Health Equity, 2022, https://www.instituteofhealthequity.org/resources-reports/health-inequalities-in-hong-kong-a-life-course-approach/full-report.pdf

^[4] Stonewall, LGBT in Britain: Health Report, 2018, https://www.stonewall.org.uk/system/files/lgbt_in_britain_health.pdf

^[5] YARA M. ASI, Advancement and Inequity in the Arab World’s Medical and Pharmaceutical Sectors, Arab Center Washington DC, 2022, (last accesswed May 2023) https://arabcenterdc.org/resource/advancement-and-inequity-in-the-arab-worlds-medical-and-pharmaceutical-sectors/

^[6] US Food and Drug Administration, 2020 drug trials snapshot. Summary report, 2020, https://www.fda.gov/media/145718/download

^[7] Flores LE, Frontera WR, Andrasik MP, et al. Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials. JAMA Netw Open. 2021;4(2):e2037640. doi:10.1001/jamanetworkopen.2020.37640

^[8] American Diabetes Association, Statistics About Diabetes, (last accessed May 2023), https://diabetes.org/about-us/statistics/about-diabetes

^[9] Zucker, I., Prendergast, B.J. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ 11, 32 (2020). https://doi.org/10.1186/s13293-020-00308-5

^[10] Kaye JB, Schultz LE, Steiner HE, Kittles RA, Cavallari LH, Karnes JH. Warfarin Pharmacogenomics in Diverse Populations. Pharmacotherapy. 2017;37(9):1150-1163. doi:10.1002/phar.1982

^[11] US Food and Drug Administration, 2020 drug trials snapshot. Summary report, 2020, https://www.fda.gov/media/145718/download

^[12] Ramamoorthy, A., Pacanowski, M., Bull, J. and Zhang, L. (2015), Racial/ethnic differences in drug disposition and response: Review of recently approved drugs. Clin. Pharmacol. Ther., 97: 263-273. https://doi.org/10.1002/cpt.61

^[13] US Food and Drug Administration, FDA Takes Important Steps To Increase Racial and Ethnic Diversity in Clinical Trials, 2022, https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials

^[14] Pahus, L., Suehs, C.M., Halimi, L. et al. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials?. BMC Med Ethics 21, 72 (2020). https://doi.org/10.1186/s12910-020-00509-y

^[15] Bodicoat, D.H., Routen, A.C., Willis, A. et al. Promoting inclusion in clinical trials—a rapid review of the literature and recommendations for action. Trials 22, 880 (2021). https://doi.org/10.1186/s13063-021-05849-7

^[16] Cochrane KM, Hutcheon JA, Karakochuk CD. Strategies for improving recruitment of pregnant women to clinical research: An evaluation of social media versus traditional offline methods. DIGITAL HEALTH. 2022;8. doi:10.1177/20552076221095707

^[17] Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. J Med Internet Res. 2020;22(11):e22179. Published 2020 Nov 4. doi:10.2196/22179

^[18] Veeva Systems, Veeva Digital Clinical Trials Survey Report, 2022, https://www.veeva.com/resources/veeva-digital-clinical-trials-survey-report/

^[19] UN International Telecommunication Union (ITU), 2.9 billion people still offline, 2021, (last accessed May 2023), https://www.itu.int/en/mediacentre/Pages/PR-2021-11-29-FactsFigures.aspx

^[20] Pew Research Center, 7% of Americans don’t use the internet. Who are they?, 2021, (last accessed May 2023), https://pewresearch-org-preprod.go-vip.co/fact-tank/2021/04/02/7-of-americans-dont-use-the-internet-who-are-they/

^[21] Ofcom, Digital exclusion: A review of Ofcom’s research on digital exclusion among adults in the UK, 2022, https://www.ofcom.org.uk/__data/assets/pdf_file/0022/234364/digital-exclusion-review-2022.pdf