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Therapeutic Innovation & Regulatory Science|July 7, 2026
Different Clinical Questions Need Different EstimandsOliver Keene, Helle Lynggaard, Christine Fletcher, et al.Therapeutic Innovation & Regulatory Science|June 29, 2026
The Effect of Covariate Adjustment for Cox Regression in Cardiovascular Outcome TrialsAlexander Przybylski, Björn Holzhauer, Simon WandelTherapeutic Innovation & Regulatory Science|July 1, 2026
Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now?Revathi Ananthakrishnan, Patrick Mitchell, Dong Xi, et al.Therapeutic Innovation & Regulatory Science|June 19, 2026
Case Study on the Use of Real-World Evidence in a Feasibility Assessment of a Randomized Controlled Trial Design to Support the Fulfillment of Pediatric Requirements with the FDA and EMANeal E Storm, Christine Kubik, Ghislaine Priem, et al.Therapeutic Innovation & Regulatory Science|June 25, 2026
Quantifying the Financial Return on Investment of Risk-Based Quality Management Implementation in Clinical DevelopmentAbigail Dirks, Sylviane de Viron, Kenneth McFarlane, et al.Therapeutic Innovation & Regulatory Science|June 27, 2026
The CARE Program: An Initiative of Patient-Focused Drug Development for Rare Diseases by NMPALing Tang, Songmei Xie, Lijia Yuan, et al.Therapeutic Innovation & Regulatory Science|July 28, 2026
Career Paths to Drug Development and Regulatory Science Through the U.S. Food and Drug AdministrationSusan M Abdel-Rahman, Gelareh Abulwerdi, Issam Zineh, et al.Therapeutic Innovation & Regulatory Science|July 19, 2026
Guidance on Transparent Sponsorship Reporting in Industry Associated Delphi Studies (TRIAD): Recommendations Based on a Systematic ReviewChristopher F Brewer, Thomas J G Chase, Edward DonnelyTherapeutic Innovation & Regulatory Science|September 19, 2018
Breakthrough Therapy Designation: CDER Analysis of Requests 4 Years Into the ProgramRyan Conrad, Kimberly Taylor, Miranda Raggio, et al.Therapeutic Innovation & Regulatory Science|May 2, 2018
A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC)Arthur Caplan, Alison Bateman-House, Joanne Waldstreicher, et al.Pageof 165