When it comes to conducting clinical trials for new medications in local communities, patient recruitment is an ongoing challenge. Roughly 4 out of 5 clinical trials fail to recruit enough participants to proceed, resulting in study delays and increased research costs.
“We always need to get more patients into clinical trials,” said Gene Jay, a clinical pharmacist and head of clinical trial solutions at Evernorth. Jay leads a data analytics team that reviews the medical and pharmacy data from over 40 million covered patients to find ideal candidates for clinical trials of experimental drug treatments.
While his team has had success recruiting participants, the industry still faces a shortfall, Jay said as he moderated a panel session at this year’s Collaborating for Novel Solutions Summit, which included representatives from five companies within the clinical trial industry. During the panel, these experts discussed ways they have navigated patient recruitment challenges. These approaches include identifying appropriate therapeutic areas to study, making local connections and building community awareness, engaging with treating practitioners, and addressing the concerns of potential participants and their families.
From left to right, moderator Gene Jay, Evernorth, and panelists Melanie Igwe, ViuHealth; Matt Walz, Trialbee; Jane Myles, DTRA;
Sigurd Süssmuth, MD, Boehringer Ingelheim; and Beverly Assman, Genentech.
Taking a therapeutic approach
Two of the panelists represent pharmaceutical manufacturers, one in the United States and one in Germany. Both agreed that the experimental drugs’ therapeutic areas, not the specific drugs, guide the decision to conduct a localized clinical trial.
The disease state targeted by the experimental drug also plays a role. Drug trials for conditions that affect many people, such as Alzheimer’s disease or oncology, tend to have higher patient recruitment and engagement, said Beverly Assman, program director for the biotech company Genentech in California. She added that treatments of rare diseases are exceedingly difficult to conduct in a local area due to a lack of patients.
Dr. Sigurd Süssmuth, clinical program leader at Boehringer Ingelheim in Munich, added that finding candidates for treatments of psychiatric diseases is more difficult than for treatments targeting physical health conditions.
Establishing local connections
Jane Myles, a program director at the Decentralized Trials Research Alliance (DTRA), which works to make clinical trials accessible to people in the areas where they live, said a local approach to clinical trials has been long overdue. In her early days of patient recruitment, the usual strategy was to work only with prominent academic research centers. Moving to local community research sites can help improve the diversity of patient participants by offering trial opportunities to populations that were not typically represented in the past. She added that local trial sites, which can include neighborhood facilities and federally qualified health centers, may need support to create the infrastructure of processes and tools to be able to conduct study assessments aligned with clinical trial requirements.
To help drive recruitment in local trial sites, trial sponsors frequently connect with local patient advocacy groups. For example, ViuHealth, which provides digital management tools, a care team and resources for people with autoimmune diseases, partners with 18 patient advocacy groups to help notify local communities of drug trial opportunities, said Melanie Igwe, the company’s chief operating officer. Many advocacy groups have a national footprint with chapters across the country. “What’s really special about working with these groups is that you get to really dial into the needs of the local area patients,” Igwe said. She added that understanding the cultural nuances of each area is crucial to developing effective communications for prospective trial participants. For example, she said, optimal messaging and engagement approaches for recruiting Latino patients would differ between Houston, Texas, and New York City.
Matt Walz, the CEO of Trialbee, a patient recruitment and enrollment platform company supporting clinical trials in nearly a dozen countries, said his company gives considerable consideration to local cultural sensitivities in their recruitment activities. He also noted that patient advocacy groups hold great potential for trial recruiting, and having a centralized digital platform has been helpful in engaging these groups. When patient advocacy groups started to use Trialbee’s recruitment platforms, they began submitting a significantly higher number of prospective candidates, he said.
Building community trust
Another key to effective recruitment is to move away from the “transactional approach” of abruptly presenting patients with a clinical trial opportunity, Jay said, and instead have clinical trial sponsors “lay the groundwork” with community awareness. Walz’s organization partners with Acclinate, which arranges community education and activity programs centered around the health conditions the trial drug is designed to treat. This engagement is done months in advance of the trial to help build trust within the community and empower potential participants to make a more informed decision when it is time to recruit.
Assman added that building community trust via education helps address the stigma that comes with being diagnosed with certain health conditions, as well as with the pharmaceutical trials themselves.
Engaging treating practitioners
Noting that the rate of doctor referrals to clinical drug trials is extremely low, the panel sees a great opportunity to educate physicians. When Assmann participated in a panel discussion for a continuing medical education course in 2022, she found that many of the general practitioners in attendance were unfamiliar with the basic concepts of clinical trials. “That tells me they are not likely to refer their patients to participate,” she said.
Boehringer Ingelheim continuously informs treating physicians about the details of their numerous clinical trials, Süssmuth said. The company also developed a special training program with the help of academic and clinical partners in various locations to ensure their program would be well-received across different countries and communities.
Myles observed that doctors may view clinical trials as losing control of their patients’ care to the research doctor. She suggested involving the patient’s treating provider in the clinical trials to help maintain continuity of care. Prior to working for the DTRA, Myles was part of a tech startup that developed methodologies for decentralized clinical trials, including a “bring your own provider” model where the patient’s primary care physician would provide routine treatment. That way, at least some of the patient’s care remains with their doctor, who is informed of trial results to guide future treatment.
However, this type of physician involvement can present its own set of challenges. “Physicians would definitely love to support more studies,” Igwe said, “but the infrastructure, the time, and the staff needed to operationalize the study, as well as to make sure that they are providing the best care as well as administering what they need to – that is where the difficulties lie.”
To reduce those challenges, ViuHealth developed a large language model to help physicians expedite patient identification for autoimmune drug trials. This algorithm maps medical records to the trial’s inclusion and exclusion criteria to quickly find patients who are most likely to benefit from participating. Any technology or process that can shorten the time to identify patient candidates can be meaningful to physicians, Igwe said.
Myles believes that treating physicians should be compensated for the additional work of being involved in clinical trials, depending on their level of engagement. Some cross-stakeholder groups are beginning to develop compensation models.
Centering the trial around the patient
Patient attitudes around clinical trials is another key challenge to recruitment. There is a great deal of negative press coverage around clinical drug trials that outweighs positive ones. Igwe said ViuHealth partners with local patient advocacy groups to dispel the myths of clinical trials and to emphasize the ways trials ensure patient safety and maintain effective treatment.
Because patients can be apprehensive if they do not fully understand the purpose of the study or what benefits participants would gain, those two points need to be clearly communicated with potential candidates, Walz said. “Comparing the individual’s current level of care to what the clinical trial is offering usually provides the basic positioning we need for the patient messaging,” he said.
Recruitment really begins at protocol design, Süssmuth said. Boehringer Ingelheim shares information with potential candidates before the trial begins and asks about their expectations and concerns. Their input helps inform the final protocols to create a trial that patients want to participate in, he said.
Genentech also asks for patient feedback in the pre-protocol stage, Assman said, as well as throughout the clinical trial to identify any modifications that need to be made along the way.
In order to understand what guides a person’s decision to participate in a clinical trial, Myles recommended that clinical trial sponsors review the Perceptions and Insights Study from the Center for Information and Study on Clinical Research Participation (CISCRP). She added that CISCRP is available to explain its findings and how these perceptions have changed over time.
The panelists also spoke about the importance of including family members in the communication and education process, as they can have significant influence on a patient’s willingness to participate in a clinical trial. “Investigators tell me that they can invest 30 minutes or more in consent conversation. The patient may agree to participate, and in three minutes their family talks them out of it,” Myles said. “The family often doesn’t know what the trial is about and what their loved one is going to go through. They need to be part of the decision-making process.”
Igwe agreed that everyone involved in the patient’s treatment journey – from medical providers to family members and caregivers – should be made aware of the benefits of participating in a clinical trial. “With an investigational drug, they may find that the therapy the person is receiving in the trial will be better than the treatment they are currently getting,” she said. “Ultimately, these patients may be one step closer to achieving the quality of life they want.”
(Note: Some of the quotes in this article were lightly edited for clarity.)