ALT FDA logo top right. What is a pragmatic clinical trial? A clinical trial designed to efficiently inform decision-making on the benefits, burdens and risks of health interventions in representative populations by including pragmatic elements that 1) are partially or fully integrated into routine clinical practice or 2) that streamline trial design and conduct. Pragmatic elements - Design features that can be integrated into a clinical trial including but not limited one or more of the following elements: broad eligibility criteria, simplified recruitment and follow-up, flexibility in delivery of the intervention (e.g., community settings), flexibility in assessment frequency, measurement of outcomes relevant to the population.

ALT FDA logo. Project 5 in 5 - Crowdsource oncology community to identify 5 clinically-relevant questions in oncology using FDA-approved therapies that can be answered through pragmatic trials over 5 years-Open May 5-July 5, 2024!

ALT Graphic of an origami crane made from a paper drug label. Text: Project Livin' Label Labeling Unfolded - Knowledge Released AACR - American Association for Cancer Research FDA - U.S. Food & Drug Administration

ALT FDA Oncology Center of Excellence FDA approves capivasertib with fulvestrant for breast cancer