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Therapeutic Innovation & Regulatory Science|June 23, 2023
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010-2020: A Cross-Sectional StudyMichael Phan, Carmen Cheng, Vivian Dang, et al.
Therapeutic Innovation & Regulatory Science|August 6, 2023
Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability PoliciesSpencer Phillips Hey, Maria Dellapina, Kristin Lindquist, et al.
Therapeutic Innovation & Regulatory Science|July 5, 2023
Defining InsightsAlicia A Cadogan, Jerry Lau, Susan Wnorowski, et al.
Therapeutic Innovation & Regulatory Science|September 21, 2018
Clinically Meaningful Outcomes in Early Alzheimer Disease: A Consortia-Driven Approach to Identifying What Matters to PatientsMichael T Ropacki, Kristin Hannesdottir, Suzanne Hendrix, et al.
Therapeutic Innovation & Regulatory Science|July 14, 2026
A Regulatory-Ready Bayesian Evidence Framework across Clinical Development and Pharmacovigilance: Practical Expectations from FDA, EMA, and ICH GuidanceCarlos G Bernaus, Maria Lilia Bournissen
Therapeutic Innovation & Regulatory Science|June 23, 2026
Identifying and Deploying Benchmarks for Clinical Research at SitesRida Momin, Laura Mangiarini, Alexandre Dias Tavares Costa, et al.
Therapeutic Innovation & Regulatory Science|June 22, 2026
Real-World Evidence for Drug Approvals: Moving Toward Greater Regulatory ClarityTala H Fakhouri, Rasika Kalamegham, Nicole Mahoney, et al.
Therapeutic Innovation & Regulatory Science|June 18, 2026
Predicting the Treatment Regimen Estimand in Phase 3 Studies from the Estimated Efficacy Estimand Based on Phase 2 DataZhili Qiao, Yu Du, Jitong Lou, et al.
Therapeutic Innovation & Regulatory Science|June 30, 2026
Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research ContextDaniele Napolitano, Mattia Bozzetti, Rosario Caruso, et al.
Therapeutic Innovation & Regulatory Science|September 22, 2018
Adaptive Design: Results of 2012 Survey on Perception and UseCaroline Claire Morgan, Susan Huyck, Martin Jenkins, et al.
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