Sluga-O'Callaghan M, Derrien Ansquer V, Frugier G, Houghton K. Evaluation of national approvals and data-collection durations in retrospective noninterventional medical record review studies conducted in the United States, Canada, Europe, and Asia. Poster presented at the ISPOR Europe 2022; November 6, 2022. Vienna, Austria.

OBJECTIVES: Real-world data is playing an increasingly important role in clinical research and healthcare decision making. To inform real-world evidence generation strategy planning, our aim was to document approval/classification durations (ACD) and overall data collection duration (DCD) in retrospective, noninterventional medical record review studies (MRRs) conducted in North America, EU, and Asia.

METHODS: We analyzed 5 years (2017-2022) of internal project data for 47 completed or ongoing MRRs across 13 countries. Panel recruitment was used for 22 studies and site-based recruitment for 29 studies (2 studies used both). Data collection was initiated in 29 studies. Twenty-seven national classifications were submitted across 3 countries; 99 single-site submissions were approved across 8 countries; and, 28 central/national submissions were approved in 5 countries. Mean ACD was compared by type of recruitment (panel [national-level submissions] vs. site [local submission]) and country. Time to data collection completion was estimated using the Kaplan-Meier method, with comparisons between panel- and site-based collection made controlling for COVID-19 timing (before or after 2020) and country.

RESULTS: The mean (SD) time from submission to approval for national activities was 27.0 (44.7) days versus 63.3 (53.8) days for local activities (P<0.001). National activities ranged from 10.7 (8.1) days in the US to 75.2 (64.3) days in Spain. Local activities ranged from 29.0 (18.5) days in Taiwan to 175.7 (81.2) days in Italy. Median DCD was 48 days (95% CI: 39, 56) for panels versus 143 days (95% CI: 107, 161) for site-based (HR = 0.11; 95% CI: 0.06, 0.21; log-rank P<0.001). Median DCD varied as a function of country (P<0.001), but there was no significant effect of COVID-19.

CONCLUSIONS: Timelines for approval to conduct MRRs and for DCD varied substantially based on study type and country. Understanding these variations can inform planning for real-world evidence generation and country selection.

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