2023-02-14-艾昆纬-临床试验设计如何影响不同人群的入组（英）_12页_1mb

White Paper Summary: Clinical Trial Design and Diverse Populations

• Overall Willingness: Hispanic and Black/African American participants expressed the highest initial interest in participating in clinical trials. Willingness varied by race/ethnicity.
• Trial Design Impact:
  • Trial design affects willingness to participate across all groups.
  • The impact of specific design elements varies significantly by race/ethnicity.
  • Hispanics: Design elements affected their willingness more (39/42 questions showed negative impact). They showed greater concern (19/26 responses had higher than average impact).
  • Black/African Americans: While generally more willing, were less affected by design elements overall (14/42 significant differences, mostly "more effect" than average). Some elements (like overnight stays) showed less impact compared to others.
  • Whites & Asians: Fewer design elements showed significant differences compared to Hispanics and Black/African Americans.
• Key Design Elements:
  • Visit Schedule: Highest overall impact, particularly regarding required visit frequency and overnight stays. Data shows specific visit lengths differently affect willingness.
  • Noninvasive Imaging: Overall had little effect on willingness for most groups except Black/African Americans, who were more likely to find it burdensome.
• Statistical Differences: Many design elements’ impact on willingness differed significantly by race/ethnicity. Hispanics showed the most variability, while Whites the least.
• Data Driven Approach (DIPA): IQVIA’s Data-Informed Protocol Assessment uses survey data to quantify element impacts by therapeutic area/phases. The 2021 survey included explicit race/ethnicity data to explore burden differences for DEI goals.
• Implications: Insights are crucial for designing trials aiming for diversity and inclusion. Assumptions about uniform participation barriers by race/ethnicity may be inaccurate, and data-driven design adjustments are necessary for effective minority recruitment without inadvertently reducing willingness.