Defining Clinical Trial Estimands: A Practical Guide for Study Teams with Examples Based on a Psychiatric Disorder Elena PolverejanMichael O’KellyMarc K. Walton Analytical Report Open access 27 May 2023 Pages: 911 - 939
Medicinal Product Development and Regulatory Agilities Implemented During the Early Phases of the COVID-19 Pandemic: Experiences and Implications for the Future—An Industry View Gaia GeraciJanis BernatGinny Beakes-Read Review Open access 02 June 2023 Pages: 940 - 951
Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices Christina M. WebberAnne Riberdy HammerMichelle E. Tarver Review Open access 09 June 2023 Pages: 952 - 956
AI/ML in Precision Medicine: A Look Beyond the Hype Zhiheng XuBipasa BiswasBilly Amzal Review 13 June 2023 Pages: 957 - 962
Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions Isa InadaFumiyuki KiuchiHisashi Urushihara Original Research Open access 18 May 2023 Pages: 963 - 974
Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions Isa InadaFumiyuki KiuchiHisashi Urushihara Correction Open access 28 May 2023 Pages: 975 - 975
Patient Preferences Regarding Surgical Treatment Methods for Symptomatic Uterine Fibroids Olufemi BabalolaDavid GebbenVeronica Price Original Research Open access 20 May 2023 Pages: 976 - 986
Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study Kebede FufaTesfa MarewAyenew Ashenef Original Research 21 May 2023 Pages: 987 - 996
Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study Mai G. El-MarakbyMohamed H. SolaymanNagwa A. Sabri Original Research Open access 25 May 2023 Pages: 997 - 1007
Analysis of a Binary Outcome Dichotomized from an Underlying Continuous Variable in Clinical Trials Jianghao LiYu DuYongming Qu Original Research 02 June 2023 Pages: 1008 - 1016
Negotiating Your Way Through the Vigilance Agreement Maze—is There a Better Way? Catherine Corbel-EcalardJean Kilgour-ChristieDavid J. Lewis Original Research Open access 03 June 2023 Pages: 1017 - 1029
The Medical Science Liaison Role in Spain: Opinion of the Commercial Department Personnel Cristina García GarcíaMartina Riosalido MonteroAdela Matesanz Marín Original Research 07 June 2023 Pages: 1030 - 1039
Benchmarking Patient Engagement Capabilities and Preparedness of Drug Development Sponsors Jennifer Y. KimMaria Paula Bautista AcelasKenneth Getz Original Research 19 June 2023 Pages: 1040 - 1049
Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the Question Wendy Manko SingerElizabeth MacEntee PileggiDavid John Lewis Original Research Open access 21 June 2023 Pages: 1050 - 1061
Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study Michael PhanCarmen ChengMonica A. Muñoz Original Research 23 June 2023 Pages: 1062 - 1073
A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter Switches Matt FisherKapil Rawal Original Research Open access 25 June 2023 Pages: 1074 - 1080
Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment Lidia BetchevaJennifer Y. KimKenneth Getz Original Research Open access 30 June 2023 Pages: 1081 - 1098
Evaluation of FDA Labeling Changes Related to PREA Safety–Waivers Jason KrasteinDenise Pica-BrancoEthan D. Hausman Original Research 30 June 2023 Pages: 1099 - 1103
Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System Ha N. TranTien N. T. NguyenNhung T. H. Trinh Original Research 30 June 2023 Pages: 1104 - 1112
Implementation of Regulation (EU) No 536/2014 as a Non-commercial Sponsor: An Internal Survey and a Descriptive Analysis of Timelines Jelle StansSara VerbandtAngélique Deleersnijder Original Research 30 June 2023 Pages: 1113 - 1120
Correction: Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters Marion WolfsŁukasz BojarskiLinda B. Sullivan Correction Open access 10 June 2023 Pages: 1121 - 1121