Abstract: Important Methodological Considerations and Strategies for Resolution for Multinational Retrospective Chart Review Studies

 

Abstract: Important Methodological Considerations and Strategies for Resolution for Multinational Retrospective Chart Review Studies

In the absence of secondary sources of health care data, chart review studies are necessary to fulfill peri- and post-approval evidence gaps such as informing on patient profiles, treatment effectiveness, and clinical and safety outcomes. Multinational studies (conducted in more than one country) are essential in understanding how to best address global medical needs; however the conduct of these studies poses its own set of challenges. Our objective was to explore the design and operational challenges and strategies to overcome these challenges in order to ensure successful conduct of multinational chart review studies.