In a novel approach to better understand factors affecting clinical trials, researchers conducted clinical trial simulations focusing on African-American and lower-income populations.
Almost half of all clinical trials are unable to recruit their target sample size. Additionally, dropout of patients during the trial can be as high as 30 percent. Two of the main factors affecting recruitment and retention in clinical trials include race and socioeconomic status.
The underrepresentation of these minority groups in clinical trials affects the outcomes of studies and their applicability to these patient populations. Particularly for patients with systemic lupus erythematosus (SLE), this underrepresentation of African-Americans is concerning because SLE is almost four times more prevalent in this population.
The results of the study “Simulating clinical trial visits yields patient insights into study design and recruitment,” and the full list of recommendations for future clinical trials, can be found in the open-access journal Patient Preference and Adherence.
Researchers conducted two simulations where patients went through mock trial visits. These simulations were run by Deilotte (London, UK) on behalf of AstraZeneca. The first study involved African-American patients from Grady Hospital, an indigent care facility in Atlanta, Georgia. The second involved low- to middle-class white patients from a hospital in Altoona, Pennsylvania. Patients were mock recruited to Phase 2 and Phase 3 anifrolumab studies. Anifrolumab is in clinical development for the treatment of SLE and lupus nephritis (LN).
These mock trials involved four phases: Site feasibility assessment, recruitment of patients, simulated hospital visits, and a final debriefing session.
Patients from both the Atlanta and Altoona simulations provided similar recommendations for future studies. They both requested access to background material before and during the study. Patients also thought the informed consent forms were too long and too complex, and thought it was important to have knowledgable staff to answer questions directly related to the trial.
Researchers noted that in both simulations, patient participation was driven by a combination of self-interest and concern for others.
Importantly, differences between these patient populations and their involvement in clinical trials also were noted. Specifically, African-American patients in the Atlanta simulation had a greater preference for information from the internet and placed more importance on community and online support. They also recommended involving a sponsor or patient ambassador to engage with the community to increase education and awareness about involvement in such studies. Unlike the patients in the Altoona study, Atlanta participants mentioned a taboo regarding SLE, which most is likely due to lack of education, the study suggested.
Financial concerns also were higher in the Atlanta simulation, where African-American participants requested more access to transportation and child care during their hospital visits, as well as reimbursements due to the impact on their work.
Generally, Atlanta participants were more likely to be underinsured or lack insurance, and for this reason, were more satisfied with participation in the trial even if they were in the placebo group.
Lessons learned through these clinical trial simulations can improve future clinical trial study designs, the authors said. These recommendations can ease patient concerns.
The authors emphasized that understanding clinical trial procedures is essential to increase recruitment and retention, particularly for minority groups. They added that “these patients need sufficient representation in clinical trials so that researchers and patients can better understand the efficacy and safety of drugs in this population and results can be generalized to relevant patient groups.”