Many researchers struggle with recruitment for clinical trials, diverse populations in particular, because they are limited to their own clinic population. At the Medical University of South Carolina (MUSC), researchers corresponded with patients who opted in for contact.
“However, that number was less than 52,000, over 80% white, and 65% female – not very representative of our state,” says Patrick Flume, MD, associate vice president for clinical research in the Office of the Vice President for Research.
MUSC recently switched to a new patient outreach recruitment model.1 Researchers can contact patients unless they opt out. The new process has dramatically increased the number of potential study participants who can be contacted, to more than 1.7 million patients. “Implementing this new process brings research opportunities to all of our patients,” Flume says.
MUSC Health recently expanded its clinical operations throughout South Carolina so it can provide cutting-edge treatment options to rural residents. The new patient outreach recruitment model similarly creates opportunities for diverse research participants.
“Diversity and inclusion in clinical research play a critical role in improving health disparities and is a significant area of focus for multiple federal agencies,” Flume notes.2
Some patients are harder to reach than others due to geographic, economic, socioeconomic, or other reasons. Those people simply have not participated in studies, largely because enrolling them would pose additional challenges to researchers in terms of regulations, budgeting, or workflow. “But we cannot let samples of convenience drive our research practices and study designs,” Flume says.
Researchers must enroll a representative population to assure the results are generalizable. “We need to demystify the research experience and make research opportunities known to all who might be eligible,” Flume says.
The new patient outreach recruitment process reflects these core ethical principles:
• Autonomy. Since all patients can be contacted, people can make an informed decision on whether to participate. Some patients are learning about treatment opportunities about which they otherwise would be unaware.
“These may be patients who are not frequently seen in clinic, or do not possess the resources or experience in searching for opportunities online,” Flume says.
Previously, many people did not realize they needed to opt in to learn about research opportunities. If those patients were not told about a research study by their clinicians, they never would be contacted.
“Now, they can opt out of all future research contact, or they can choose whether or not to participate in an individual study,” Flume reports.
Researchers assume all patients are eligible until they opt out. It does not mean patients will be contacted, since there could be a lot of potentially eligible candidates. If there are persons with specific interests in trials, researchers refer them to a website (SCresearch.org), where they can see if there are open studies for their condition at other institutions.
• Beneficence. “We believe in the potential benefits of research participation both at a patient level and a societal level. It is the institution’s responsibility to allow our patients the opportunity to participate so that they can reap any potential benefits,” Flume says.
Researchers conducted focus groups to learn about patients’ concerns regarding study participation contact. Although people were supportive of contact, they did not want to be inundated with calls and emails, particularly if they already receive a lot of clinical communication from MUSC. To minimize that risk, researchers initially set up parameters for contact frequency.
“We settled on allowing three study teams to reach out to a patient within a six-month time frame,” Flume reports.
Each of those study teams could make only one contact attempt. After a patient reached three contacts, they were blocked from appearing on additional study recruitment reports until six months had passed since the first contact.
• Justice. “Reducing the risk of sample bias was a major motivating factor for developing our cold-contact process,” Flume says.
Researchers wanted to ensure there was appropriate representation from all the groups for which an intervention might be used. Previously, study participants were limited to those who were proficient using patient portals, or proactive in seeking out research participation opportunities.
“This can lead to biased results, and also unfair burden and fatigue on those populations,” Flume cautions. “Recruitment efforts must extend beyond the clinic spaces.”
REFERENCES
- Pittman T, Bell L, Jones S, et al. Enhancing study recruitment through implementation of an opt-out, cold contact process with consideration for autonomy, beneficence and justice. J Clin Transl Sci 2023;7:e63.
- National Academies of Sciences, Engineering, and Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington, DC: The National Academies Press; May 17, 2022. Summary.
The Medical University of South Carolina recently switched to a new patient outreach recruitment model. Now, researchers can contact patients unless they opt out. The new process has dramatically increased the number of potential study participants who can be contacted, from 52,000 to more than 1.7 million patients.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content