Patient Engagement, Patient Recruitment and More at C3 Summit

At the C3 Summit, Matt Holms, Citeline VP for Patient Engagement & Recruitment, discussed challenges of participant enrollment and retention, and offered solutions to address them.

By Darcy Grabenstein

“It changed our lives. It changed my life,” said Matt Holms, Citeline Vice President for Patient Engagement and Recruitment, of his son’s participation in a clinical trial. Holms was one of several panelists who shared their deeply personal experiences in a session on patient engagement in the commercial track at the C3 Summit (Conversations on Clinical Content) in Princeton, sponsored by TransPerfect.

Matt Holms

Just prior to the pandemic, Holms’ son was diagnosed with autism spectrum disorder but immediately began getting necessary services and was starting to thrive. When the pandemic hit, his son was cut off from needed support services and his condition deteriorated. “It was hell,” Holms said, sharing that it was his hardest moment as a parent watching his 4-year-old son significantly regress; he stopped talking and began getting physical with his brother. “We were prisoners in our own house, let alone the pandemic. … We were desperate.”

Out of the blue, Holms said, he received an email about a stem cell trial for autism spectrum disorder at Duke University. He explained that when his son was born, they had stored umbilical cord tissue and cord blood for potential future stem cell therapies. Holms said the irony is that he has worked in clinical trial patient recruitment for years but only found out about this unique study opportunity via an email from the company storing their son’s umbilical cord blood and tissue.

“We had an incredible experience,” Holms said of the trial, adding that his son, now 8, is a different person since the study, which made a material difference in his mental processing abilities. He emphasized the importance of sponsors providing a positive experience, as it will encourage others to participate in clinical research. Holms shared his experience with parents in his local autism community, and as a result one of his son’s pre-K classmates also enrolled in the study of 137 participants.

Others who told their personal stories included patient advocate Ella Balasa, founder of Balasa Consulting, who lives with cystic fibrosis; and Kristin Smedley, cofounder and CEO of the Curing Retinal Blindness Foundation, whose two blind sons lead successful lives.

Panel moderator Leanne Woehlke, executive VP of Soglia, a division of Entrada, also asked the panelists about more practical matters, such as how to improve the clinical trial experience for patients. Holms suggested that sponsors need to invest more in developing a relationship with patients other than when they need them for study enrollment and/or once they are filling prescriptions. Sponsor commercial teams invest heavily to engage patient populations in post-marketing, but R&D needs to invest more in engaging with target patient populations before, in between, and after studies — if the foundational trust and awareness is there first, this will lead to improved enrollment.

One way to strengthen that relationship is by easing the financial burden for trial participants. He noted that, in order for his son to participate in the autism trial, his family had to travel 500 miles and stay in a hotel for three nights, two separate times, over a six-month period. They received a one-time $500 stipend, which only put a dent in their out-of-pocket expenses.

Holms also lent his expertise in a session of the summit’s R&D track, “Proven Practices That Move the Needle on Patient Recruitment & Retention,” which revealed many of the challenges sponsors face in this area. Woehlke also served as moderator of this session, and asked attendees to raise their hand if they had participated in a clinical trial. Only a few people raised their hand, including me. In fact, I’ve participated in two clinical trials, both from the comfort of my own home.

More complicated, complex protocols are compounding efforts to recruit and retain clinical trial participants. Holms said “the problem often starts way before the study rolls out” where clinical operations teams are often tasked with operationalizing a study protocol designed to recruit “needle-in-the-haystack” patients. Moreover, there is a supply-and-demand imbalance where there simply are not enough research sites, which are commonly under-resourced, for sponsors to find the necessary volume of patients within their desired timelines.

Despite this complexity, the traditional process of site selection hasn’t dramatically changed. However, Holms noted that there's a “fundamental shift” occurring: Sponsors are taking more ownership of the site selection process versus a reliance on CROs. They are relying more on real-world data (RWD) or longitudinal patient data from electronic medical records (EMR), electronic health records (EHR), labs, and claims data.

Holms noted how Citeline is supporting this process with the consolidation of its RWD assets with its proprietary data assets. All these data points are now connected, he explained, and silos have been removed via tokenization, which has created a truly unique data asset to provide sponsors visibility into current and historical data that are linked at the investigator, HCP, and patient levels. Tokenization involves anonymizing sensitive patient data by replacing identifiable information (PHI) with unique tokens, ensuring patient privacy and confidentiality. This facilitates a 360° view of patients, disease, and providers that can be used to pinpoint a protocol-specific population. This unique data asset, Holms added, reveals trends in how HCPs are treating patients, combining disparate patient medical records and then providing that direction to sponsors via a multitude of value-added clinical use cases across the feasibility-site selection-patient recruitment continuum.

Of course, any gathering of life sciences professionals would be remiss if it did not include discussions around artificial intelligence (AI). The C3 Summit did not disappoint, with sessions on the use of AI in clinical trials and AI-driven digital marketing strategies. Other sessions focused on medical affairs, company culture, staff training, and eCOA licensing and application.