Published November 18, 2020
The number of clinical trials occurring worldwide continues to grow at a steady pace (ClinicalTrials.gov). Yet not all trials make it to the finish line. Some, in fact, are terminated before ever enrolling participants. Recruitment challenges are a key factor.
A 2015 article in Clinical Trials found that in a study of “2,579 eligible trials, 481 (19%) either terminated for failed accrual or completed with less than 85% expected enrollment, seriously compromising their statistical power.” Trial terminations due to recruitment issues can mean lost diagnostics, therapeutics, medical procedures, devices, behavioral changes, and potential treatments. The COVID-19 pandemic has made enrollment issues even more pronounced.
Overcoming these challenges requires creativity, foresight, and expert assistance. For researchers at the University at Buffalo, that assistance comes from the recruitment team at UB’s Clinical and Translational Science Institute. The team provides personalized consultations that are helping researchers overcome the obstacles in their paths and hit their recruitment goals.
Analyzing recruitment challenges
The CTSI recruitment team’s main points of contact are Clinical Recruitment Coordinator Briana Getman, MSW, and Community Recruitment Liaison Danielle Abramo-Balling, together with other members of the CTSI’s Community Engagement and Integrating Special Populations cores.
“Knowing the strategies to reach different target populations is key, and so is engaging them throughout the process of designing and implementing a study,” Getman says. “Many community members would be interested in participating in a study, but they are never asked or reached out to. We try to bridge that gap between investigators and participants.”
Balling adds that recruitment plans must be engaging and clear in order to encourage eligible participants to reach out with interest. “Building relationships in the community takes time, time that the research team might not have built into their plans,” she says.
UB researchers can reach out for assistance at various stages in a study’s life cycle. Balling says it is ideal to meet with teams as they are planning their projects, but consultations can be a difference-maker at any point in the process.
“Many times, researchers come to the CTSI recruitment team after they have been open to enrollment for a while and the strategies they outlined in their initial protocol aren’t working the way they expected,” Getman adds. “However, teams who have a consultation with us even earlier can see a greater benefit to recruitment.”
Balling adds that the Community Engagement team “can help design recruitment strategies starting with the grant writing stage and work with a team all the way through to dissemination of their findings to the community.”
Similarly, the types of studies that can benefit from a consultation are varied — including simple online surveys, randomized controlled clinical trials for specific health conditions, single-site and multi-site trials.
“We help to engage healthy volunteers, as well,” Balling says. “We’ve assisted several studies that needed healthy controls based on age, gender and race.”
Also essential is encouraging researchers to focus on recruiting underrepresented populations. Balling says the CTSI has worked to create opportunities for education in the community, and to build an understanding of and excitement for science and research.
“Our Buffalo Research Registry is 48% minority based on race and areas with health disparities based on ZIP Code data,” she says. “We work to make sure everyone in the community has the opportunity to participate if they want, and we also educate research teams on engaging these populations in research, their barriers to participation, and how to address those barriers.”
The consultation process
No two studies are alike, and the same is true of recruitment consultations.
“Each study receives personalized recruitment solutions,” Getman explains. “Recruitment is a little bit art and a little bit science. We use evidence-based methods, but there is always an element of creativity needed.”
Meetings can occur with either the study’s principal investigator alone, or the entire study team. Before the consultation, the recruitment team reviews study materials, including the protocol, informed consent, and any recruitment materials that have been created.
“We then share customized suggestions for recruitment and troubleshoot current pain points in the recruitment funnel,” Getman says. “We always follow up afterwards with a summary of our suggestions and an action plan for teams to follow.
In many cases, the recruitment team refers the researchers to other CTSI cores, community organizations, or even to other researchers who might be able to provide assistance. After the suggested strategies are implemented, the team checks in again to see how effective the plan was and if it needs refining.
Aside from suggestions about where and how to recruit, strategies can include:
“Sometimes some simple changes in the wording of an ad can totally change a potential participant’s perception of the study,” Getman says.
The impact of COVID-19
After COVID-19 hit, Balling explains, “recruitment was totally shut down. As it reopened, research teams came up with creative solutions to continue recruitment, including updating their protocols to make their interactions with participants completely virtual whenever possible.”
These modifications actually expanded the potential participant pool.
“Suddenly, people in Cattaraugus County who might not have made the trip to a UB campus were able to participate remotely,” Balling says. “Getting in touch with our rural community members who are interested in participating in research has been a valuable outcome of this unexpected shift.”
Some research teams still require in-person access, and Getman says researchers are handling these situations with the utmost caution.
“We have seen research teams highlight the ways they are keeping participants safe in their recruitment materials and when they screen participants,” she says. “They are explaining the procedures they have in place, like wearing proper PPE and sanitizing areas, so that participants feel more comfortable being involved in research.”