Overcoming Recruitment Challenges and Increasing Representation and Diversity of Participation in Early MCI Clinical Trials: The MIND Study Experience

Abstract Background The MIND ( M emory I mprovement with N icotine D osing) study is an ongoing trial to determine whether long‐term transdermal nicotine treatment results in sustained cognitive improvement and attenuation of cognitive decline in patients with MCI. To improve the demographic representation of screened and randomized study participants, the MIND Study Underrepresented Group (URG) Recruitment and Retention (R&R) Initiative was established. Method The goal was to increase the screenings and randomizations of participants who self‐report as belonging to an underrepresented race or ethnic group or report a low educational attainment level (high school completion or less). Key elements of the initiative comprised of: (a) financial support of site infrastructure, (b) centralized support with culturally relevant recruitment materials, (c) monthly meetings to secure best practices, and (d) dissemination of successful strategies. Measurement of success included overall screening and randomization rates, as well as qualitative and quantitative metrics reported by initiative sites. Result Nine sites (25% of active study sites) participated in this initiative from March 2022‐February 2023. The first three months required development of site‐specific recruitment plans, goal setting, and needs assessments. During this year, we observed an increase in URG screenings (21.3%) and randomizations (33.3%) (Table 1). Similar increases were observed in race and ethnicity (25.4% and 44% respectively) as well as low educational attainment (21.2% and 31.6% respectively) groups. This initiative improved the overall URG monthly screening from 2.23/month prior to the initiative to 2.42/month during the initiative and the monthly randomization rate from 0.93/month to 1.58/month. Site‐reported data on the pre‐screening activity indicated that the main reasons for pre‐screen fails were participants either not belonging to an URG (56%) or not meeting MCI criteria (20%). Concerns around study burden, study partner availability and nicotine were reported in less than 10% of the pre‐screened individuals. Conclusion This initiative successfully increased the representation of screened and randomized MIND Study participants with respect to self‐reported race, ethnicity, and educational level. Initial success suggests that a multifaceted approach coordinated through close collaborations between sites and the central coordinating center are necessary to screen and randomize representative populations in early MCI trials.