Study and clinical trial recruitment made easy

The Duke Trial and Recruitment Innovation Center provides no-cost support to help Duke investigators recruit and retain study participants.

February 5, 2018

Lawrence David, PhD, studies the human gut microbiome—the unique and diverse community of micro-organisms living in each of our bodies. He doesn’t mind diving deep into the world of bacteria, and is perfectly at home culturing pathogens, analyzing samples, and building data models in a laboratory.

But David also wants to apply his work to the lives of real people, which means he needs to recruit real people to participate in studies.

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“As a basic scientist, I believe that some of the most important work we do is translational, getting our research out of the lab,” says David, an assistant professor in Department of Molecular Genetics and Microbiology in the Duke School of Medicine. “But sometimes there’s a hesitation to translate, because administrative and logistical issues can seem like a barrier.”

Recruitment for human subject studies and clinical trials is one such barrier, asking investigators not only to navigate the funding and Institutional Review Board (IRB) process, but to effectively promote their study to potential volunteers. In 2018 the NIH will start requiring recruitment plans with all grant applications, putting increased emphasis on this aspect of research.

Knowing the challenges ahead, David and Durand reached out to the Duke Trial and Recruitment Innovation Center, part of Duke’s Clinical and Translation Science Institute (CTSI). The Center provides no-cost consultations to Duke investigators and study teams, helping them develop practical, effective recruitment and retention plans for their studies and clinical trials.That’s why, when David and lab manager Heather Durand began designing a study on the effect on prebiotics on gut flora, they decided to seek expert help.

“I’m really grateful that an outfit like the Trial and Recruitment Innovation Center has been built at Duke,” David says. “Knowing that there are experts providing support and guidance is really exciting. It’s been a nice surprise and such a welcome help to what we do.”

‘It makes me want to participate in my own study’

Study recruitment is both an art and a science, according to Sabrena Mervin-Blake, director of recruitment innovation at CTSI. It involves a deep knowledge of participant populations, the regulatory environment, and marketing tactics. Nationwide, approximately two-thirds of clinical trials fail to meet their recruitment timelines.

“We encourage researchers to invest extra time developing a recruitment and retention plan early in the process, rather than risk getting stuck later on, unable to meet their recruitment goals,” Mervin-Blake says. “This saves both time and money in the long run.”

David and Durand did just that, enlisting the team’s help with their grant and IRB submission materials.

A series of consultations gave focus to their recruitment efforts, David says. “They helped us crystallize exactly who we were trying to have participate in our study. They challenged us to think about our study as a marketing problem, which I found really helpful. That doesn’t mean it’s commercial, it means defining a group of people and figuring out how to connect with them.”

The expertise of the Trial and Recruitment Innovation Center team informed everything from strategies for recruiting and retaining volunteers to poster design and participant instruction forms. To encourage volunteers to stick with it, the study team designed a colorful and interactive web-based tool to share results with the participants.

“The materials we created with their guidance were a lot more user-friendly and attractive,” David says. “It’s the kind of thing that makes me want to participate in my own study.”

He adds that the consultation not only improved the design of the present study, but also taught them best practices they will take forward to future projects. “Our skill in designing a study like this has gone way up thanks to the Trial and Recruitment Innovation Center.”

“I think we’ll definitely be using them again in the future,” Durand says. “They’re very responsive, and when you have this subject-matter expertise in-house at Duke, it’s kind of a no-brainer.”

Story by Ben Miller