Levine CA, Ansquer V. Ethical considerations: conducting retrospective non-interventional medical record review studies in Europe. Poster presented at the 2017 ISPOR 20th Annual European Congress; November 8, 2017. Glasgow, Scotland.

OBJECTIVES: Ethics requirements in retrospective non-interventional medical record reviews (NIMRR) are highly variable by country. National requirements range from none to multiple submissions requiring approvals. At the site-level, requirements range from non-existent to mandatory approvals and contracts. Differences in country-specific ethics processes can delay data collection and thus provision of timely research. In this study, we sought to quantify variability in ethics-related aspects of NIMRRs.

METHODS: Based on internal project data, we evaluated variability in ethical and regulatory procedures for 13 (12 oncology, 1 psychiatry) NIMRRs completed across 15 countries in Europe.

Sixty-one national notifications/submissions were reviewed and approved across 8 countries; 21 single-site submissions were approved across 3 countries; and 56 notifications/submissions to all participating sites were approved in 6 countries, resulting in >7,300 medical records abstracted. Five countries did not have established ethics requirements for conducting anonymized retrospective reviews. Among those that did, the timeline from ethics initiation to launch of data abstraction for national-level activities ranged from 1 day (United Kingdom) to 15 months (France). For site-level submissions, the timeline from ethics initiation to launch of data abstraction ranged from 2 months (Spain/Germany) to 12 months (Portugal/Italy).

CONCLUSIONS: Retrospective NIMMR studies are an effective way to gather clinical characteristics, treatment patterns, outcomes, and health care resource utilization data in real-world settings where existing data sets are unavailable, inadequate, or inaccessible. Evaluating country-specific ethics requirements and their associated timelines is a critical early step in country selection, study design, and project planning. Review timelines were generally consistent by country. National and site-based submission timelines varied substantially. More consistent regulations between countries, or a centralized approval process in Europe, would allow research to progress in a more efficient and predictable manner. Timely analysis of real-world clinical data leads to a better understanding of current practices, needs, and gaps, which ultimately benefits patients.

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