![]() ![]() However, several recent developments, including the 21st Century Cure Act, increased accessibility to large-scale routinely collected health data, improved standardization of collection, and increased high-profile regulatory applications, and have resulted in an increased demand for these data and increased availability of these data. Historically, real-world evidence from observational studies has had limited use for demonstrating therapeutic effectiveness for regulatory and reimbursement purposes. By breaking down these challenges, we provide practical solutions for researchers to consider through the approaches of detailed planning, collection, and record linkage to analyze external data for comparative efficacy. In this viewpoint article, we provide an overview of the technical challenges raised by regulatory and health reimbursement agencies when evaluating comparative efficacy, such as identification, outcome, and time selection challenges. Real-world data originate from many sources, and identifying suitable real-world data that can be used to contextualize a single-arm trial, as an external control arm, has several challenges. The preferred evidence of a large randomized controlled trial is difficult to adopt in scenarios, such as rare conditions or clinical subgroups with high unmet needs, and evidence from external sources, including real-world data, is being increasingly considered by decision makers. Online Journal of Public Health Informatics.Asian/Pacific Island Nursing Journal 11 articles. ![]() JMIR Bioinformatics and Biotechnology 35 articles.JMIR Biomedical Engineering 69 articles.Journal of Participatory Medicine 80 articles.JMIR Perioperative Medicine 91 articles.JMIR Rehabilitation and Assistive Technologies 206 articles.JMIR Pediatrics and Parenting 287 articles.Interactive Journal of Medical Research 315 articles.JMIR Public Health and Surveillance 1176 articles.Journal of Medical Internet Research 7628 articles. ![]()
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