Latest CISCRP Patient Survey Reveals Diversity Gaps, Yields 5 Tips For Improvement

By Annick de Bruin, CISCRP

Despite the FDA introducing a draft guidance document two years ago that outlined strategies to improve minority representation in clinical trials,⁴ recent studies suggest that racial and ethnic minority populations continue to remain underrepresented across the board, from ophthalmology to oncology studies.^5-7 More effort is needed to understand the views of underserved groups, such as ethnic and racial minorities, toward clinical research to improve their enrollment and participation.¹

Because it is also important to periodically reassess the values, perceptions, and barriers that may preclude clinical trial participation among potential trial volunteers, the Center for Information and Study on Clinical Research Participation (CISCRP), an independent nonprofit organization in Boston, conducts a biennial global survey called the “Perceptions & Insights” study, assessing public and patient views and experiences in clinical research. The CISCRP 2023 study⁸ offered valuable information on participant recruitment, improvement of trust and diversity, and optimized technology use as well as adaptations to post-COVID changes in clinical research. By analyzing these findings, we help provide pharmaceutical companies, CROs, regulators, and other clinical leaders with insights and strategies to improve clinical research inclusivity, efficiency, and engagement.

Here, we outline five such opportunities to improve clinical trial recruitment and participation, especially among ethnic and racial minority groups:

1. Increase trial access through HCPS and other trusted information sources.

The foundation of successful clinical trial recruitment and retention lies in the trust, reliability, and accessibility of information sources. For pharmaceutical companies, this underscores the critical importance of prioritizing transparency and actively engaging with patients to make it easier to participate in clinical research studies. By openly sharing information on the risks and benefits of treatment in a language accessible and understandable to patients, study sponsors can significantly enhance public trust.

The outcomes of our 2023 survey further underscored the critical role of physicians and HCPs in this area. We found that HCPs continue to be the most trusted source of information regarding clinical trials. In 2023, an encouraging 23% of potential participants (20% among Hispanic respondents compared to 23% among non-Hispanic respondents; 16% among Black or African Americans compared to 24% among White respondents) reported being asked by their HCPs to consider trial participation, a significant increase from 14% in 2021. While this trend highlights the pivotal role of HCPs, it is merely a starting point toward a more personalized, trust-based approach to engaging with potential trial participants, as our study indicated that the majority (66%) still do not consider clinical research as an option when discussing treatments with their doctor.

Pharmaceutical companies and stakeholders should prioritize leveraging trusted sources of information to build trust and facilitate access to clinical trials. This might mean collaborating more closely with physicians and HCPs — particularly those practicing in minority community settings — to actively strengthen educational efforts, initiatives, and feedback loops between HCPs and trial sponsors. For example, this could include creating clear, accessible content that HCPs can easily review and share with potential participants, providing HCPs with e-learning modules on the latest trial protocols, or easy-to-access online portals that could feature regular updates on upcoming trial recruitment, progress, and outcomes on ongoing or completed trials.

Likewise, patient advocacy and support groups also play a pivotal role, especially among minority communities, with email invitations proving to be the most effective recruitment method. Patient advocacy groups proved to be especially successful in increasing clinical research engagement among Black respondents (12% reported being asked to participate by an advocacy group) compared to White respondents (6% reporting the same), highlighting the importance of leveraging these groups for broader, culturally sensitive trial outreach.

2. Increasing diversity and building trust with patients is mutually beneficial.

The diversity of trial participants is a critical factor that directly influences the trust and relevance of pharmaceutical companies among diverse populations, particularly in light of historical and current injustices in clinical research. The CISCRP study showed that trust in pharmaceutical companies among Black respondents (32%) was more likely to be increased if a company demonstrated workforce diversity. This proportion further increased to 52% when trials included a diverse set of participants.

These findings further reinforce the importance of sponsors to consider targeted and inclusive strategies, which may involve a combination of:

• implementing policies and practices aimed at recruiting a diverse workforce,
• ensuring clinical trial participant pools reflect the demographic diversity of the population affected by the condition, and
• actively engaging with ethnic and racial minority groups and community leaders through direct outreach programs, employing culturally sensitive and language-appropriate materials and communication strategies to effectively engage potential participants.

3. Expand accessibility through alternative site models.

Venturing beyond the traditional clinical trial setting also can offer unique opportunities to enhance the convenience of participation and significantly improve the diversity of trial participants at the same time. According to our study, 46% of participants overall were very willing and 38% were somewhat willing to go to a local pharmacy for their study visits. This trend also was observed among various demographic groups (percent responses of “very willing”: Black: 53%, White: 48%, Hispanic: 44%, Asian 34%).

A separate CISCRP survey performed 10 years ago¹⁰ highlighted the benefits of pharmacists directly engaging with patients and providing education about clinical trials. The concept of using pharmacies as alternative sites for studies gained traction, especially when CVS and Walgreens launched their clinical trials initiatives in the early 2020s.¹¹ Despite the noted participant openness, however, 15% of our study respondents were still not very, or not at all, willing to consider a pharmacy site, citing concerns with the facilities/lack of privacy, confidentiality of information, quality of care, and quality of answers to questions.

Outside of the traditional clinical site model, respondents were receptive to three different clinical study models (i.e., hybrid, mobile nurse, and remote) and provided high marks for “very willing to participate” — 43%, 44%, and 43% respectively for each model. Furthermore, having access to some trial site visits closer to home or having some visits conducted virtually were both highly chosen factors for long-term retention, at 66% and 58%, respectively.

CROs and pharmaceutical companies are encouraged to form partnerships with pharmacies and other local health facilities to develop innovative alternative trial sites and clinical study models. Sponsors, however, should carefully establish standardized protocols for alternative clinical sites that prioritize participant convenience and care, ensure appropriate staffing and staff training, and communicate where participant information is securely managed.

4. Leverage technology for optimized recruitment, retention, and enhanced participant experience.

The integration of technology in clinical trials is yet another important factor for improving recruitment and diversity. In our study, 34% noted it was very important to use mobile applications, while 32% expressed interest in using eConsent. Technology adoption was notably higher among Hispanic and Black respondent subgroups, and both groups were more likely to cite the importance of mobile app availability and the ability to review and sign documents in an electronic format compared to non-Hispanic and White subgroups. Additionally, 66% of respondents were comfortable using their personal computers for clinical trial data entry, 61% with wearable devices and clinical apps, and 58% with video conferencing with physicians. Text messaging emerged as another helpful tool, with 65% of respondents indicating its usefulness. The use of text messaging in patient communications also has increased since 2021 (22% compared to 29% in 2023). While technology offers significant benefits, some concerns were again noted, with 18% of respondents indicating that smartphone or tablet use during studies disrupted their daily routines.

Pharmaceutical companies might consider focusing on creating secure, intuitive, and user-friendly mobile applications that serve as one-stop portals for trial information, consent, and data collection. Seeking direct input from trial participants and pilot testing the initiative with ethnic and racially diverse user groups before launching these programs will help ensure that these technologies meet the needs of diverse communities. Using wearable devices, text messaging, smartphone apps, and video conferencing may also help to maintain continuous engagement with trial participants and help improve remote monitoring and communication.

5. Retain post-COVID-19 progress made in clinical trials.

Despite its challenges, the COVID-19 pandemic significantly accelerated the use of technology and innovative trial models between 2020 and 2022, and many industry professionals were hopeful about the lasting positive effects of these technological advancements. However, when we compared our 2023 study findings with the data from 2019 and 2021, we noticed a shift to pre-pandemic practices, including lesser use of eConsent forms and reduced participant communication during and after the trial. For example, from 2021 to 2023, there was a decrease of 12% for eConsent usage and 9% for video consent usage.

Pharmaceutical companies should continue to stay agile and adaptive in response to evolving trends and challenges while maintaining the momentum toward more flexible, technology-driven trial models. One such strategy may involve commitment to the #NoGoingBack initiative¹², ensuring that innovations and efficiencies gained during the pandemic are not lost but, rather, built upon. Emphasizing clear communication during and post-trial, timely feedback, and quality of care in clinical trials may perhaps help. This includes continuing to leverage virtual visits, remote monitoring, and digital consent processes, and ensuring these practices solidify in the clinical trial landscape.

Putting It All Together

By enhancing trust and diversity, expanding access to alternative clinical sites, and leveraging technology use, the pharmaceutical industry and stakeholders may drive significant advancements in clinical research and move toward a more inclusive and participant-friendly future. We propose several strategies that, if adopted, would help improve access and deepen engagement in clinical trials, especially among ethnic and racially underrepresented communities.

About the CISCRP 2023 Perceptions & Insights Study

The CISCRP 2023 Perceptions & Insights Study provides a global overview of current trends, challenges, and opportunities within the clinical trial industry from a patient and public perspective. The questionnaire was developed with input from a cross-functional workgroup — including representatives from pharmaceutical and biotechnology companies, patient advocacy groups, and CROs. It was distributed online from April – June 2023 with support from Clariness, James Lind Care, Benchmark Research, and Rare Patient Voice and resulted in responses from 12,017 participants. This article does not capture in totality the insights derived from the study; however, you may access additional resources here: https://www.ciscrp.org/results-from-ciscrps-2023-perception-insights-study/. Also of note, a peer-reviewed article that takes a deeper dive into the diversity insights captured by the survey respondents is forthcoming.

References:

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2. MacLennan DL, Plahovinsak JL, MacLennan RJ, Jones CT. Clinical Trial Site Perspectives and Practices on Study Participant Diversity and Inclusion. Clin Pharmacol Ther. 2023;113(3):670-679. doi:10.1002/cpt.2817
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7. O’Donoghue J, Luther J, Hoque S, et al. Strategies to improve the recruitment and retention of underserved children and families in clinical trials: A case example of a school-supervised asthma therapy pilot. Contemp Clin Trials. 2022;120:106884. doi:10.1016/j.cct.2022.106884
8. CISCRP 2023 Perceptions and Insights Study. Accessed February 2024. https://www.ciscrp.org/services/research-services/perceptions-and-insights-study/.
9. CISCRP. Journey to Better Health Mobile Exhibit. Bringing Clinical Research Information to Local Communities. Accessed February 2024. https://www.ciscrp.org/mobileexhibit2023/
10. Getz, Kenneth; Leveraging Pharmacists as a Channel to Raise Clinical Research Literacy Among Patient Communities. Applied Clinical Trials, Vol. 22, Issue 10. October 2013. Accessed February 2024. https://www.appliedclinicaltrialsonline.com/view/leveraging-pharmacists-channel-raise-clinical-research-literacy-among-patient-communities
11. Natalia Mesa. “Walgreens Launches Partnership with Prothena to Compete with CVS, Walmart” May 01, 2023. Biospace. Accessed February 2024. https://www.biospace.com/article/walgreens-launches-partnership-with-prothena-to-compete-with-cvs-walmart/
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About The Author:

Annick de Bruin has worked in partnership with patients and caregivers to incorporate their voice in the drug development process over the past 20+ years. She has extensive experience in the clinical research industry as well as a background in market research. Ms. de Bruin, together with the CISCRP Research Services team, has pioneered and implemented a broad array of methodologies to solicit feedback from patients, care partners, and the public — including focus groups, in-depth interviews, user testing, and online surveys — and collaborated with various stakeholders to help these organizations act on these valuable insights.