Randomized Comparison of Online Motivational Themes in Clinical Trial Recruitment.

BACKGROUND Black adults in the United States (US) face significant cardiovascular health disparities, which are likely exacerbated by the underrepresentation of Black adults in cardiovascular clinical trials. The Black US population has experienced unique historical events, discriminatory practices, and practical obstacles that might contribute to this underrepresentation in clinical trials. Improved understanding of motivations that encourage or discourage participation in cardiovascular clinical trials can lead to more effective clinical trial recruitment and help mitigate these cardiovascular health disparities. OBJECTIVE Using an online survey, determine which motivational themes in clinical trial recruitment advertisements are most effective in encouraging Black adults to participate in a hypertension-focused trial. We also explored how trust in healthcare and various demographic factors influenced their decision to participate. METHODS We conducted an online survey with 829 self-identified Black adults in the US, using a between-subject design to test four literature-derived motivational themes in clinical trial recruitment advertisements: (1) contribution to science, (2) helping the community, (3) lowering blood pressure, and (4) access to perks ($500 worth of groceries or an equivalent cash amount). We assessed advertisement appeal, willingness to participate, and willingness to recommend clinical trial participation to others using Cumulative Link Mixed Models (CLMM). RESULTS Demographic factors played a more significant role than motivational themes in predicting advertisement effectiveness. Adults aged 40-59 and individuals diagnosed with high blood pressure were more likely to find the advertisements appealing and express willingness to participate. Urban residents engaged more with the advertisements compared to those in suburban or rural areas. Participants with liberal (OR: 1.37, 95% CI: 1.01-1.85, p = 0.044) and conservative (OR: 1.62, 95% CI: 1.09-2.40, p = 0.018) political views were more willing to participate in the clinical trial compared to those with moderate views. However, the “Lowering my blood pressure” theme was less effective among individuals who distrusted healthcare institutions (OR: 0.40, 95% CI: 0.16-0.97, p = 0.042) and also reduced willingness to recommend the trial (OR: 0.36, 95% CI: 0.15-0.85, p = 0.020). Additionally, higher trust levels were unexpectedly associated with lower willingness to participate when exposed to this theme (OR: 0.41, 95% CI: 0.17-0.98, p = 0.044). CONCLUSIONS This study contributes new empirical evidence on the science of inclusive trial recruitment and provides an evidence-based approach to using recruitment advertisements to improve clinical trial participant diversity.

Background: Recruitment for clinical trials is driven by participants’ motivations, including scientific discovery, study incentives, personal health benefits, and community contribution. Recruitment success depends on balancing initial interest with a participant’s commitment to the study topic and their eligibility. There is little data characterizing the impact of distinct motivational themes on trial recruitment. Objective: To compare the impact of four distinct motivational themes on participant interest, commitment, and eligibility for the two hypertension trials. Methods: The GoFresh trials examine how healthy groceries affect blood pressure among Black adults from Boston food priority areas. Using Facebook’s “A/B testing” feature, users 18 years and older in qualifying ZIP codes were randomly assigned to view one of four digital ad themes emphasizing: science volunteerism, study incentives, blood pressure reduction, and wellness in the Black community between November 2023 and July 2024 (Figure). We captured the number of clicks to our website according to the ad version. ‘Inquiries’ (interest) were defined as those who completed an information request form on the trial website. These individuals underwent a prescreening telephone visit and an in-person screening visit. ‘Commitment’ was based on “no-shows” (persons who scheduled an in-person visit but did not attend), while ‘Eligibility’ was based on participants who qualified for the study following the in-person visit. Results: The ads generated 28,090 clicks, 233 inquiries, 65 scheduled visits, and 23 eligible participants. As shown in the Table, the community theme generated the most clicks and inquiries per click but showed lower commitment and lower eligibility. While the blood pressure theme had the lowest interest, these participants showed the highest commitment and the highest eligibility rate. Conclusion: Beyond generating study interest, motivational themes may select for participants with varying degrees of commitment and eligibility, which could affect the cost effectiveness of recruitment and long-term retention. These findings have important implications for timely and representative recruitment for cardiovascular trials.

Mitigating Administrative Risks in Industry-sponsored Clinical Trials

Background: Despite bearing a disproportionately high burden of cardiovascular disease, Black adults remain grossly underrepresented in clinical trials. Culturally tailored, digital recruitment strategies such as tailored websites using specific thematic messaging may improve trial representativeness, but the effectiveness of these themes remains unclear. Objectives: We sought to evaluate the effectiveness of different motivational themes, within a digital recruitment website, on engagement and clinical trial sign-up rates among Black adults. We hypothesized that non-standard themes, especially the community well-being-focused theme, would increase engagement in a cardiovascular clinical trial compared to standard websites. Methods: We implemented digital recruitment for GoFresh , a randomized cardiovascular clinical trial testing the effect of a DASH diet grocery intervention on blood pressure among Black adults. Website themes were derived from pre-developed motivational categories. These themes included (1) contribution to science (standard), (2) community well-being, (3) personal blood pressure improvement, and (4) access to perks (groceries or cash). A/B randomization directed study site visitors to 1 of each theme randomly between June and December 2024 ( Figure ). The Matomo web analytics platform captured visitor behavior, including visits, pageviews, time on site, and sign-ups to complete trial pre-screening. We compared themes using Welch’s t-tests to estimate mean differences in metrics between the control (standard science theme) and each variant. Statistical significance was defined as two-tailed P <0.05. Results: There were 11,902 visitors over 6 months ( Table ). The community-focused message yielded the most trial sign-ups. All alternative variations led to significantly higher pageviews per visitor compared to the science-based message (≥67% increase, P <0.001). When comparing all four themes, the community-themed message also yielded a modestly higher average time spent on site (mean: 1 min 4 sec; 8.1% detected effect; P ≤0.05). Conclusion: Tailored digital messages emphasizing community and health benefits significantly improved engagement and trial interest. Digital strategies employing culturally tailored messages may enhance equitable recruitment within cardiovascular disease research, but future work should examine eligibility, screening efficiency, and randomization rates.

Health Care Equity and Justice Scorecard To Increase Diversity in Clinical Trial Recruitment and Retention.

Same-Day Consent for Regional Anesthesia Clinical Research Trials: It's About Time.

Introduction: A key barrier to stroke clinical trial recruitment is the lack of experienced investigators at the site level. However, there are currently no standards for training Vascular Neurology Fellows in clinical trial recruitment. We studied the impact of a formal clinical trial didactic curriculum on stroke fellows. Methods: Our institution initiated clinical trial training for Vascular Neurology Fellows in 2016 with the curriculum expanding year upon year (Figure 1a). We reviewed all clinical trial enrollments from 2015-2022 and determined the number completed by stroke fellows. The proportion of fellow enrollments was analyzed using the Mann-Kendall test. We surveyed past fellows to obtain their feedback on the clinical trial training curriculum and determine whether they were actively participating in clinical trials or planned to do so in the future. Results: Fourteen of sixteen (87.5%) past fellows completed the survey. Figure 1b shows fellow enrollment and total enrollments by academic year. The Mann-Kendall test demonstrated a trend for an increasing proportion of fellow enrollments during the study period (p=0.08). Seven past fellows (50%) are currently enrolling in clinical trials; four of whom (57.1%) enrolled greater than or equal to three subjects during fellowship. Thirteen (92.8%) intend to enroll in clinical trials in the future. Past fellows stated that the most valuable aspect of their clinical trial training was learning how an enrollment works and obtaining an informed consent. Conclusion: Our results show that a clinical trial didactic curriculum during Vascular Neurology Fellowship might increase clinical trial recruitment by fellows. Furthermore, engagement in clinical trial training and recruitment during fellowship was suggestive of continued engagement in future practice.

ObjectiveThe objective of our research is to conduct a comprehensive review that aims to systematically map, describe, and summarize the current utilization of artificial intelligence (AI) in the recruitment and retention of participants in clinical trials.Materials and MethodsA comprehensive electronic search was conducted using the search strategy developed by the authors. The search encompassed research published in English, without any time limitations, which utilizes AI in the recruitment process of clinical trials. Data extraction was performed using a data charting table, which included publication details, study design, and specific outcomes/results.ResultsThe search yielded 5731 articles, of which 51 were included. All the studies were designed specifically for optimizing recruitment in clinical trials and were published between 2004 and 2023. Oncology was the most covered clinical area. Applying AI to recruitment in clinical trials has demonstrated several positive outcomes, such as increasing efficiency, cost savings, improving recruitment, accuracy, patient satisfaction, and creating user-friendly interfaces. It also raises various technical and ethical issues, such as limited quantity and quality of sample size, privacy, data security, transparency, discrimination, and selection bias.Discussion and ConclusionWhile AI holds promise for optimizing recruitment in clinical trials, its effectiveness requires further validation. Future research should focus on using valid and standardized outcome measures, methodologically improving the rigor of the research carried out.

Introduction: Clinical genomics leads to more effective cancer prevention, diagnosis, and treatment. Prostate cancer (PC) significantly impacts Black and Hispanic men, but participation in clinical trials and PC risk management methods like genetic testing and screening remains low. Barriers to diversity and inclusion in clinical trials include cultural and socioeconomic factors. Digital storytelling is an effective tool for building trust and increasing community engagement. We aim to develop and assess the use of digital storytelling to improve recruitment of Black and Hispanic patients in a trial for men at high genetic risk for developing PC (clinicaltrials.gov NCT03805919) and raise awareness of genetic testing and enrollment in clinical trials within these communities. Methods: Guided by the Assessing Community Engagement Conceptual Model, we will establish a community advisory panel (CAP) comprised of patient advocates, community, and clinical partners with a strong interest in increasing clinical trial representation of Black and Hispanic patients at high genetic risk for developing PC. CAP participants will be identified from existing partners and through snowballing techniques, which involve asking partners to recommend other CAP participants. The CAP will co-design storytelling interview questions, baseline, and outcome assessments and collectively determine effective methods for digital story dissemination. To evaluate the impact of storytelling on awareness, interest, and participation in genetic testing, medical management, and clinical trial recruitment among Black and Hispanic men, outcome assessments co-designed with the CAP will be administered pre and post-video viewing and include viewer qualitative interviews. Results: Filmed interviews with Black and Hispanic participants will be conducted. Interviews will focus on participant experiences with clinical trials, genetic testing, and cancer risk management. Interview transcripts will be in English and Spanish with forward and back translation to ensure accuracy using National Institutes of Health resources. Local and national partners, community organizations, faith-based institutions, healthcare facilities, and advocacy groups identified by the CAP will facilitate dissemination. Digital stories will be distributed across various multimedia platforms to maximize outreach and accessibility, including community web platforms, social media channels, podcasts, local radio stations, educational workshops, health fairs, cultural events, churches, and support groups. Conclusion: Building strategies for improving patient-centered care delivery and community engagement within culturally diverse populations will enhance clinical trial diversity and inclusion. Using digital storytelling as a recruitment strategy for clinical trials can foster trust, engagement, and participation within Black and Hispanic communities. Study findings will contribute to future clinical trial design and recruitment to enhance underrepresented minority participation in clinical research. Citation Format: Yi Liu, Brenda Adjei, Anna Couvillon, Kathleen Calzone, Fatima Karzai. Utilizing digital storytelling to improve the recruitment of Black and Hispanic patients for a genetic predisposition to prostate cancer screening trial [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A115.

Clinical trials are often hindered by inadequate patient recruitment. Overly optimistic investigator predictions of participation can lead to unmet recruitment goals and costly trial extensions. A patient-focused approach estimating recruitment in clinical trials may provide higher accuracy. To assess the feasibility of recruitment in a future deep brain stimulation (DBS) in early-stage Parkinson's disease (PD) multicenter trial by understanding motivations and concerns to participation of past and potential future DBS in early-stage PD clinical trial subjects. To identify motivating factors and barriers influencing trial participation, an end-of-trial survey was administered to subjects enrolled in a DBS in early-stage PD pilot trial with subjects randomized to receive DBS plus optimal drug therapy (DBS+ODT) or ODT alone (NCT#00282152, IDE#G050016). Pilot trial survey results were analyzed in conjunction with results of a previously-reported survey querying PD patients about potential participation in a trial for DBS in early-stage PD with similar inclusion/exclusion criteria. Pilot trial subjects reported high levels of satisfaction with their participation in the study. Similar motivations and barriers to participation were expressed in comparable proportions by subjects who successfully completed the pilot trial and patients with early-stage PD considering enrollment in a comparable DBS study. The FDA has approved a prospective, randomized, double-blind, phase III, multicenter, pivotal clinical trial evaluating DBS in early-stage PD (IDE#G050016). These results suggest that the successful recruitment and retention of early-stage PD subjects, as observed in the pilot trial, is attainable in a future pivotal trial.

OBJECTIVES/GOALS: Patient recruitment, enrollment, and retention continues to be one of the leading barriers to successful clinical trials, and results do not always reflect the diversity of the general population. This systematic review aims to assess the impact of decentralized methods on recruitment, retention, and diversity on recent clinical research. METHODS/STUDY POPULATION: A systematic search of the literature, using databases such as PubMed, Cochrane Library and EMBASE to find publications reporting on the aspect of recruitment in decentralized clinical trials was performed. The titles and abstracts of the publications were assessed, excluded those lacking sufficient or pertinent information regarding decentralization in clinical trials. The remaining publications were reviewed for those reporting sufficient data regarding the impact of decentralization on the aspect of recruitment in clinical trials to be included in the focused analysis. Studies reporting on participant retention and diversity in addition to recruitment were emphasized. RESULTS/ANTICIPATED RESULTS: This systematic search returned 13 studies highlighting the role of decentralized clinical trial methods impacting participant recruitment, retention, and diversity in clinical trials. Out of the 13 studies, 10 reported improved recruitment using virtual or decentralized methods, and 7 of these reported improvements when compared alongside with traditional methods. 7 studies reported a positive impact on participant retention, with 4 of these directly comparing decentralized methods with traditional methods. Lastly, of these studies, 5 were reported to have trended towards diversity in the demographics of the sample population, including race or geographic location. DISCUSSION/SIGNIFICANCE: Related reviews have stated a lack of published comparable data to determine if DCTs (Decentralized Clinical Trials) improved recruitment and retention. Results suggest this review addresses such a gap, by providing data on how decentralized methods can benefit recruitment and retention, potentially highlighting a new standard.

2444 Development of an instrument to identify factors influencing point of care recruitment in primary care settings: A pilot study at University of Utah Health

Background: Clinical studies are indispensable for the development and clinical introduction of new therapies. Particularly in the field of rheumatology, there is a high need for the development of new drugs because for most rheumatic diseases a curative treatment is not yet available. Furthermore, a large percentage of patients are not even treated adequately with approved treatment options. Treatment is particularly challenging for those entities that belong to the so-called orphan diseases because effective drugs have yet to be developed and approval of new drugs is difficult due to the fact that only small numbers of affected patients can be recruited for clinical trials. Despite the need for new developments and thus clinical studies, patient recruitment for clinical trials in Germany is generally difficult. Therefore, sponsors frequently use non-European study centers to enroll the necessary numbers of patients as inadequate patient recruitment leads to increased costs and delayed implementation of new medical knowledge. Objective: Given the overall limited recruitment rates for clinical studies in Germany, it was the aim of this work to gain insights into motivations for and barriers to participating in clinical trials in Germany from the patients’ point of view. Methods: Data was collected using a structured questionnaire in three groups of patients who are suffering from a rheumatic disease and are receiving specialist care. The completely anonymous questionnaire included a total of 32 questions, divided into four main topics. All questions could only be answered by yes or no or by selecting or not selecting a choice of the answer provided. Per question, proportions of patients selecting yes or no or any of the choices were compared between groups and between males and females. Results: It was found that there is a lack of education and knowledge about the nature and offer of clinical trials among patients with rheumatic diseases. This issue represents one of the main barriers to patient recruitment for clinical trials. In addition, a large proportion of patients are concerned about the possible adverse effects of study drugs and about being used as “guinea pigs”. While the internet and daily newspapers are rarely used for education regarding study participation, it became clear that the family doctor as a trusted person and possible network partner has a special role in improving patient willingness to participate in trials. Furthermore, interviewees hope for shorter waiting times at the doctor's office and a better, regular, more intensive medical care when participating in a clinical trial. Conclusion: Better and broader information of patients can be regarded as a key to better recruitment for clinical trials since many patients, on the one hand, have certain concerns about clinical trials but at the same time do see the potential for personal advantages when participating in a trial. Information events by patient organizations and specialist centers could be a way to reach out to patients and to break down barriers with regard to participation in clinical trials. Presentations by sponsors and established clinical trial centers and intensified networking with general practitioners and specialists could probably also enhance patient recruitment.

Clinical trials play a critical role in evidence-based medicine, when rigorous scientific methodology is utilized to discover and test the effectiveness and safety of new drugs to prevent or cure diseases, including cancer. Participation in clinical trials thus becomes key to successful completion of these trials. Although it is estimated that >70% of Americans are inclined to participate in clinical trials, less than 5% of adult cancer patients participate in clinical trials. There is thus a large gap between those inclined to participate in clinical trials and actual participation in clinical trials. As with trials targeting men with prostate cancer (PCa) on active surveillance (AS), where the target population is mostly over 50 years of age, others have observed several challenges with recruitment and accrual in clinical trials. The participation rate is currently unavailable for men on primary and secondary chemoprevention trials. Additionally, with unanticipated environmental factors such as a pandemic or other natural emergencies that may severely impact the economy, personal property, travel and person-to person contact for study-related procedures, there is a need to continuously identify these challenges and determine solutions to recruitment barriers in chemoprevention trials to ensure timely completion of early phase trials. Recent studies regarding the impact of the pandemic on clinical trial recruitment have shown that cancer prevention trials were relatively more negatively impacted compared to cancer treatment trials. The goal of this manuscript is to review our experience in continuously evaluating the protocol and patient level challenges to recruiting subjects on AS for PCa in this cancer chemoprevention trial conducted at the Comprehensive Cancer Center (CCC) and report the contemporary strategies that we are utilizing to continue to recruit subjects in this trial. We provide data from our current trial as an example while discussing future strategies to improve overall clinical trial recruitment. These strategies can inform future design of contemporary cancer chemoprevention trials and, additionally, better select, focus and invest in strategies that are the most productive and efficient for recruiting target populations.

A Patient-Centric Approach to Sickle Cell Disease Clinical Trials: Integrating Patient Perspectives in the RISE UP Phase 2/3 Trial of Mitapivat for Informed Protocol Design and Associated Patient Community Benefit