Abstract The US Food and Drug Administration (FDA) created the Sentinel System in
response to a requirement in the FDA Amendments Act of 2007 that the agency establish a …

The COMPASS trial (Comprehensive Postacute Stroke Services) reported a process
evaluation of the implementation of a transitional care model to improve poststroke …

The regulation of medicines seeks to ensure the efficacy, safety, and quality of prescription
and non‐prescription medicines. Given that the conditions under which a medicine's …

Importance Only about half of patients with atrial fibrillation (AF) who are at increased risk for
stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for …

Concerns regarding both the limited generalizability and the slow pace of traditional
randomized trials have led to calls for greater use of real‐world evidence (RWE) in the …

Context Potentially inappropriate prescribing of medications in older adults, particular those
with dementia, can lead to adverse drug events including falls and fractures, worsening …

Background: There are unique opportunities related to the design and conduct of pragmatic
trials embedded in health insurance plans, which have longitudinal data on member/patient …

Mobile health (mHealth) is a rapidly expanding field within precision medicine and precision
health that provides healthcare support and interventions using mobile technologies, such …

Background Randomised controlled trials (RCTs) are the established gold-standard for the
reliable assessment of medical interventions. However, trials have become increasingly …

Introduction: Researchers and policymakers recognize that leveraging data routinely
collected in clinical practice can support improved research and patient care. Embedding …