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2021 survey highlights challenges and opportunities for investigators, coordinators, and patients.
The past two years have underscored the value clinical trials can bring to global healthcare yet sponsors and investigators continue to face challenges in fulfilling enrollment quotas.Investigators frequently cite identifying and enrolling eligible and interested patients as the area of greatest need for improvement in the clinical research process, particularly when trying to recruit a diverse and representative sample. However, ZS research found that patients are more open to clinical trials than many investigators assume. Additionally, we found that the way trials are presented—and by whom—can increase motivation to participate.
In custom Voice of Site and Voice of Patient (VOSP) research conducted last spring, ZS surveyed over 430 US respondents, including principal investigators (PIs), clinical research coordinators (CRCs) and prospective and experienced clinical trial patients across therapeutic areas. The goal was to learn about challenges and opportunities related to clinical trial recruitment and experience, particularly within historically underrepresented patient communities.
One of the most surprising findings in our research was just how willing patients are to participate in a clinical trial relative to PI expectations, even among underrepresented patients. Seventy-five percent (75%) of all patients surveyed told us they were interested in participating in a trial if recommended by their doctor, while seventy-seven percent (77%) of underrepresented patients were willing.
In contrast, investigators on average offer clinical trials to less than half (44%) of clinically eligible patients. What’s behind the gap? PIs cite concerns with schedule compliance, drug compliance, or health literacy as contributing factors. PIs further assume that only 45% of patients offered a trial would be interested.
This pre-screening based on assumed interest and ability to complete a trial significantly reduces potential trial populations. ZS’s Study of Underrepresented Patients for Equity in Recruiting (SUPER) reiterated the risks of making assumptions related to health literacy. For Black and Hispanic patients with breast cancer, for example, willingness to participate increased by 25% when the research study was described in clinically accurate, detailed language versus simpler language. Including less detail actually decreased BIPOC (Black, indigenous and people of color) patients’ willingness to join a trial, reinforcing the notion that talking down to patients can hinder recruitment efforts.
By offering clinical trial opportunities to many more patients and ensuring support to address logistical and educational needs, sponsors and sites can significantly expand the top of the funnel. Sponsors should identify potential implicit biases at play in recruitment and work with sites to implement more objective pre-screening approaches that can circumvent the opportunity for bias to influence who is offered a clinical trial. Study sponsors would do well to reconsider assumptions about language used in clinical trial materials to ensure that patients who seek out more technical information are able to access that detail.
The majority of patients interested in participating in clinical trials were motivated by a personal benefit. Sometimes this benefit was access to treatment at no cost, but patients were motivated just as often by more experience-related benefits. Seventy-three percent (73%) of patients cited the opportunity to be treated by experts who focus on their disease as a motivating factor; sixty percent (60%) noted the opportunity to receive additional care and attention from clinic staff and fifty one percent (51%) highlighted the opportunity to learn more about their own health. These findings are consistent across racial and ethnicity groups and were reinforced by trial-experienced patients who often cited the care and attention from staff, as well as ability to learn about themselves, as top reasons for a satisfactory experience. Patients who were more satisfied with their study experience often recalled direct interactions with the PI and research coordinator rather than only the trial nurse, highlighting the importance of maintaining a human touch even as clinical trials become more digital and decentralized.
Compared to patients, our findings uncovered dramatically different motivating factors for investigators who conduct trials. Two-thirds of PIs are driven by their ability to contribute to advancement of medicine and population-level benefits. Additionally, PIs tend to be less comfortable discussing potential patient benefits in a trial than speaking about more altruistic motivations, such as helping others. Raising awareness of these different “WIIFMs,” and helping investigators bridge the gap by communicating more in terms of patient benefit, could help drive greater and broader patient interest in participation.
Sponsors can help ensure the right resources are available to provide a positive patient experience throughout the clinical trial journey. That can include ensuring there’s a connection to experts; demonstrating high levels of care and attention; exhibiting strong communication throughout; and minimizing study burden. Beyond setting up these experiences, it’s important to make patients aware of what to expect upfront to increase their comfort in participating.Sponsors may consider if other roles such, as a coordinator, may be more comfortable talking to these experience-related benefits than some investigators.
Gaining the trust of potential trial participants is essential for enrollment and retention in general, but increasingly so for historically underrepresented groups. Distrust and fear are often on the minds of Black and Hispanic patients, even if they are willing to consider trials based on personal benefit. Patients in these groups shared reasons for lower participation rates, such as:
Thus, while conveying WIIFM is a starting point, it’s also important to keep in mind who is delivering the message. When we asked patients to compare their comfort level with different profiles of potential investigators, the responses were illuminating. Across all patients (including underrepresented), physician expertise and relationships were valued most. Underrepresented patients were more comfortable participating in a trial if the PI was a known expert in their condition sixty six percent (66%), a doctor they see regularly fifty six percent (56%), or someone that knew their own doctor well forty nine percent (49%). We also explored the role of demographics (e.g., same race or ethnic background, same gender) and found that these characteristics were more important for Black and Hispanic patients than for white (non-Hispanic) patients, but still less influential than physician expertise and existing relationships.
To help allay fears, build trust and increase participation of underrepresented patients in clinical trials, sponsors need to understand that a multifaceted, “yes, and” approach is required. What do we mean? Consider these three key components:
Leverage existing relationships: One of the best ways to build trust, we believe, is working with physicians who already have a strong reputation and cultural awareness of populations of interest. This may require going into new geographies, partnering with new communities, and working with new investigators that sponsors haven’t engaged before. We also believe there are dual opportunities—both in standing up new sites, as well as encouraging referral pipelines based on existing networks and relationships—to bring clinical trial access to currently underserved and underrepresented patient populations.
Increase frequency of contact: Even where an existing relationship is not present, making a conscious effort to have trial patients see a familiar face during every encounter can help sponsors build relationships and trust between patients and clinical trial professionals. This helps set expectations about study protocols and creates a greater sense of safety. Having a familiar touchpoint helps trial participants feel engaged, connected and supported, which is important across all racial and ethnic groups.
Invest in new communities and channels: Our research also indicated that sites that have been most successful in recruiting underrepresented patient populations utilize a broader array of recruitment approaches and communications channels (including direct print and digital engagement as well as community organizations, advocacy groups and nonprofits). A real-world example comes from Roche/Genentech, which established community partnerships during recruitment for a clinical trial for a COVID-19-related pneumonia treatment. The sponsor’s goal was to increase enrollment of Black, Hispanic, and Native American patients, who were disproportionately affected by COVID-19. One partnership with an Indian health clinic on a reservation led to the highest participation rate across the trial. Approximately 85% of the 389 patients enrolled in the trial were from minority racial and ethnic groups. The main driver was Roche’s commitment to investing in a community beyond only the scope and timeline of the trial.
Investigators and other site staff recognize the challenges the persist in clinical trial recruitment and are open to sponsors and other partners supporting enrollment efforts. Our VOSP research revealed three areas in which sponsors can make a difference by taking an intentional approach:
We recognize that no single tactic alone will solve the challenge of clinical trial recruitment! The important thing is to begin, step by step, with empathy and in partnership with investigators, site staff and patients themselves. Taken together, the strategies we’ve outlined should contribute to more diverse clinical trials and improved outcomes for all populations.
Sharon Karlsberg, Principal, Cathy Zeanah, Manager; both with ZS Associates