Sluga-O'Callaghan M, Ansquer V, Frugier G, Mai C. Evolution of regulatory requirements for retrospective observational studies using medical records in Austria, Belgium, Italy, Netherlands and Switzerland. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S51. doi: 10.1016/j.jval.2018.04.425

BACKGROUND: Using real-world evidence (RWE) to answer questions about dosing regimens, long-term outcomes, and outcomes in various subpopulations “is preferable to having no evidence whatsoever,” wrote three FDA staff members including Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a Viewpoint article published in the Journal of the American Medical Association in August 20172. RWE will in future play an increasing role in market access and reimbursement decisions reflecting a general shift in the way these data are viewed by the larger scientific community. Today a major hurdle for the collection of RWE in multicenter studies outside the USA are the country specific regulatory requirements.

METHODOLOGY: Documentary Method – critical analysis of country specific legislation, government body requirements and recommendations.

RESULTS: In Austria, studies involving the collection of retrospective medical records are classified as “Nicht-interventionellen Studie” (NIS) and require only notification to the central entity; Review by Research Ethics Committee (REC) is not mandatory. In Belgium for retrospective studies using already available data a REC approval comparable to clinical trials is mandatory. In Italy, studies involving the collection of retrospective medical records need to be registered at the A.I.FA. (Agenzia Italiana del FArmaco) and site-specific REC approval is required. Retrospective patient file research in the Netherlands does not fall under the Medical Research Involving Human Subjects Act (WMO), but must be approved by the pharmaceutical self-regulatory organization “The Foundation for the Code for Pharmaceutical Advertising” (CGR). In Switzerland, retrospective patient chart studies require neither need a notification nor REC approval.

CONCLUSIONS: Despite the increasing demand for and acceptance of RWE data the legislative framework for collecting such data remains variable and uncertain across EU member countries.

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