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Therapeutic Innovation & Regulatory Science|June 24, 2020
Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation InitiativeJ Stephen Mikita, Jules Mitchel, Nicolle M Gatto, et al.Therapeutic Innovation & Regulatory Science|June 13, 2020
Likelihood Ratio Test Method for Multiple Medical Devices Comparison Using Multiple-Site Data with Continuous OutcomesTingting Hu, Jianjin Xu, Lan Huang, et al.Therapeutic Innovation & Regulatory Science|August 13, 2022
Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016-2019Mei Kohama, Takahiro Nonaka, Yoshiaki Uyama, et al.Therapeutic Innovation & Regulatory Science|January 9, 2026
Patient-Perceived Overall Side Effect Bother at and After Cancer Treatment Discontinuation: An Analysis Using Commercial Cancer Trial DataJessica Roydhouse, Monique Breslin, Anne Zola, et al.Therapeutic Innovation & Regulatory Science|January 21, 2026
The Utilization of Externally Sourced Data and Data Collected and Analyzed from Previously Completed Studies Using Modelling and Simulation and Other Methodologies to Support Pediatric-Focused Regulatory CommitmentsNancy A Sherman, Kevin D Wolter, Elena SotoTherapeutic Innovation & Regulatory Science|December 17, 2025
Digitalizing Risk Minimization Measures in EU: Explorative Co-design Workshops with Expert StakeholdersMathias Møllebæk, Amalie Christine Bagger, Kirstine Lund Hansen, et al.Therapeutic Innovation & Regulatory Science|November 7, 2025
Navigating the Future: Considerations for use of Continuous Glucose Monitoring in Diabetes TrialsAnna Kettermann, Gauri Dandi, Jennifer Clark, et al.Therapeutic Innovation & Regulatory Science|November 10, 2025
Improving the Analysis of KCCQ Endpoints in Heart Failure Clinical TrialsRobin Myte, John Eriksson, Martin Rensfeldt, et al.Therapeutic Innovation & Regulatory Science|October 30, 2025
Sales Erosion of Originator Drugs Following Generic Entry: Quantitative Analysis and Predictive ModelingSoon Kyu Jung, Sang-Won LeeTherapeutic Innovation & Regulatory Science|July 16, 2025
Characteristics of Multi-Regional Clinical Trials Conducted in Asia, Focusing on Japan's Participation and Small/Medium Companies-Sponsored TrialsAkihito Kojima, Hideki Hanaoka, Yoshiaki UyamaPageof 165