Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials.

Clinical trials for Alzheimer's disease (AD) are slower to enroll study participants, take longer to complete, and are more expensive than trials in most other therapeutic areas. The recruitment and retention of a large number of qualified, diverse volunteers to participate in clinical research studies remain among the key barriers to the successful completion of AD clinical trials. An advisory panel of experts from academia, patient-advocacy organizations, philanthropy, non-profit, government, and industry convened in 2020 to assess the critical challenges facing recruitment in Alzheimer's clinical trials and develop a set of recommendations to overcome them. This paper briefly reviews existing challenges in AD clinical research and discusses the feasibility and implications of the panel's recommendations for actionable and inclusive solutions to accelerate the development of novel therapies for AD.

Strategies for Behavioral Research in Neurology: Lessons Learned During the COVID-19 Pandemic and Applications for the Future.

PURPOSE OF REVIEW: Behavioral therapies are proven treatments for many neurologic conditions. However, the COVID-19 pandemic has posed significant challenges for conducting behavioral research. This article aims to (1) highlight the challenges of running behavioral clinical trials during the pandemic, (2) suggest approaches to maximize generalizability of pandemic-era studies, and (3) offer strategies for successful behavioral trials beyond the pandemic. RECENT FINDINGS: Thousands of clinical trials have been impacted by the COVID-19 pandemic, from undergoing protocol revisions to suspension altogether. Furthermore, for ongoing trials, recruitment of diverse populations has suffered, thereby exacerbating existing inequities in clinical research. Patient adherence and retention have been affected by a myriad of pandemic-era restraints, and medical, psychiatric, and other complications from the pandemic have the potential to have long-term effects on pandemic-era study results. In the development of post-pandemic study protocols, attention should be given to designing studies that incorporate successful aspects of pre-pandemic and pandemic-era strategies to (1) broaden recruitment using new techniques, (2) improve access for diverse populations, (3) expand protocols to include virtual and in-person participation, and (4) increase patient adherence and retention.

Trial staff and community member perceptions of barriers and solutions to improving racial and ethnic diversity in clinical trial participation; a mixed method study.

Background: The lack of racial and ethnic diversity in clinical trials leads to skewed findings, limited generalizability, inequitable health outcomes for people of color, and insufficient access to innovative therapies. Our objective was to compare perceptions of barriers to participation in trials for people of color and trial staff to provide tangible solutions for improving diversity among study participants. Methods: This mixed method study utilized semi-structured interviews and surveys to evaluate barriers to participation and solutions to improve racial and ethnic diversity in clinical trials among healthcare system trial staff and community members from the same region. Through thematic analysis via coded transcripts and quantitative analysis via survey data, social support theory constructs were identified to evaluate where perceptions of barriers and solutions overlap and where they diverge. Results: A total of 55 trial staff and 75 community members participated in the study. Trial staff identified logistics and patients' unwillingness to receive additional treatments as perceived barriers to participation, while community members stated lack of information and lack of trust in their care team. Both groups identified hesitance toward research as a prominent barrier. Solutions related to informational support demonstrated the most overlap between groups, while instrumental support showed the most discordance. Conclusion: Solutions for improving racial and ethnic diversity in clinical trial participation are multi-faceted and have various levels of impact. Overlap and discordance of opinions regarding solutions should be further evaluated, and implementation of solutions should be carefully considered.

Diversity and Representation Among United States Participants in Amgen Clinical Trials.

OBJECTIVE: Describe the demographic profile of US participants in Amgen clinical trials over a 10-year period and variations across therapeutic areas, indications, and geographies. METHODS: Cross-sectional retrospective study including participants enrolled (2005-2020) in phase 1-3 trials completed between January 1, 2012 and June 30, 2021. RESULTS: Among 31,619 participants enrolled across 258 trials, one-fifth represented racial minority populations (Asian, 3%; Black or African American, 17%; American Indian or Alaska Native, Native Hawaiian or Other Pacific Islander, multiracial, each < 1%); fewer than one-fifth (16%) represented an ethnic minority population (Hispanic or Latino). Compared with census data, representation of racial and ethnic groups varied across US states. Across most therapeutic areas (bone, cardiovascular, hematology/oncology, inflammation, metabolic disorders, neuroscience) except nephrology, participants were predominantly White (72-81%). A similar proportion of males and females were enrolled between 2005 and 2016; male representation was disproportionately higher than female between 2016 and 2020. Across most medical indications, the majority of participants were 18-65 years of age. CONCLUSIONS AND RELEVANCE: While the clinical research community is striving to achieve diversity and proportional representation across clinical trials, certain populations remain underrepresented. Our data provide a baseline assessment of the diversity and representation of US participants in Amgen-sponsored clinical trials and add to a growing body of evidence on the importance of diversity in clinical research. These data provide a foundation for strategies aimed at supporting more equitable and representative research, and a baseline from which to assess the impact of future strategies to advance health equity.