1. Defining Clinical Trial Estimands: A Practical Guide for Study Teams with Examples Based on a Psychiatric Disorder

   • Elena Polverejan
   • Michael O’Kelly
   • Marc K. Walton

   Analytical Report Open access 27 May 2023 Pages: 911 - 939

   

2. 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 Geraci
   • Janis Bernat
   • Ginny Beakes-Read

   Review Open access 02 June 2023 Pages: 940 - 951

   

3. Integrating Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices

   • Christina M. Webber
   • Anne Riberdy Hammer
   • Michelle E. Tarver

   Review Open access 09 June 2023 Pages: 952 - 956

4. AI/ML in Precision Medicine: A Look Beyond the Hype

   • Zhiheng Xu
   • Bipasa Biswas
   • Billy Amzal

   Review 13 June 2023 Pages: 957 - 962

5. Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions

   • Isa Inada
   • Fumiyuki Kiuchi
   • Hisashi Urushihara

   Original Research Open access 18 May 2023 Pages: 963 - 974

   

6. Correction: Comparison of Regulations for Arsenic and Heavy Metals in Herbal Medicines Using Pharmacopoeias of Nine Counties/Regions

   • Isa Inada
   • Fumiyuki Kiuchi
   • Hisashi Urushihara

   Correction Open access 28 May 2023 Pages: 975 - 975

7. Patient Preferences Regarding Surgical Treatment Methods for Symptomatic Uterine Fibroids

   • Olufemi Babalola
   • David Gebben
   • Veronica Price

   Original Research Open access 20 May 2023 Pages: 976 - 986

   

8. Assessment of the Regulatory Approval Process of Medical Devices in Ethiopia: A Mixed Sequential Explanatory Study

   • Kebede Fufa
   • Tesfa Marew
   • Ayenew Ashenef

   Original Research 21 May 2023 Pages: 987 - 996

   

9. Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study

   • Mai G. El-Marakby
   • Mohamed H. Solayman
   • Nagwa A. Sabri

   Original Research Open access 25 May 2023 Pages: 997 - 1007

   

10. Analysis of a Binary Outcome Dichotomized from an Underlying Continuous Variable in Clinical Trials

    • Jianghao Li
    • Yu Du
    • Yongming Qu

    Original Research 02 June 2023 Pages: 1008 - 1016

    

11. Negotiating Your Way Through the Vigilance Agreement Maze—is There a Better Way?

    • Catherine Corbel-Ecalard
    • Jean Kilgour-Christie
    • David J. Lewis

    Original Research Open access 03 June 2023 Pages: 1017 - 1029

    

12. The Medical Science Liaison Role in Spain: Opinion of the Commercial Department Personnel

    • Cristina García García
    • Martina Riosalido Montero
    • Adela Matesanz Marín

    Original Research 07 June 2023 Pages: 1030 - 1039

    

13. Benchmarking Patient Engagement Capabilities and Preparedness of Drug Development Sponsors

    • Jennifer Y. Kim
    • Maria Paula Bautista Acelas
    • Kenneth Getz

    Original Research 19 June 2023 Pages: 1040 - 1049

14. Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the Question

    • Wendy Manko Singer
    • Elizabeth MacEntee Pileggi
    • David John Lewis

    Original Research Open access 21 June 2023 Pages: 1050 - 1061

    

15. Characterization of Pediatric Reports in the US Food and Drug Administration Adverse Event Reporting System from 2010–2020: A Cross-Sectional Study

    • Michael Phan
    • Carmen Cheng
    • Monica A. Muñoz

    Original Research 23 June 2023 Pages: 1062 - 1073

    

16. A Detailed Analysis of the Past 20 Years of US FDA-Approved Prescription to Over-the-Counter Switches

    • Matt Fisher
    • Kapil Rawal

    Original Research Open access 25 June 2023 Pages: 1074 - 1080

    

17. Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment

    • Lidia Betcheva
    • Jennifer Y. Kim
    • Kenneth Getz

    Original Research Open access 30 June 2023 Pages: 1081 - 1098

    

18. Evaluation of FDA Labeling Changes Related to PREA Safety–Waivers

    • Jason Krastein
    • Denise Pica-Branco
    • Ethan D. Hausman

    Original Research 30 June 2023 Pages: 1099 - 1103

    

19. Preventability of Adverse Drug Reactions Related to Antibiotics: An Assessment Based on Spontaneous Reporting System

    • Ha N. Tran
    • Tien N. T. Nguyen
    • Nhung T. H. Trinh

    Original Research 30 June 2023 Pages: 1104 - 1112

    

20. Implementation of Regulation (EU) No 536/2014 as a Non-commercial Sponsor: An Internal Survey and a Descriptive Analysis of Timelines

    • Jelle Stans
    • Sara Verbandt
    • Angélique Deleersnijder

    Original Research 30 June 2023 Pages: 1113 - 1120

    

21. 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 Wolfs
    • Łukasz Bojarski
    • Linda B. Sullivan

    Correction Open access 10 June 2023 Pages: 1121 - 1121