1. Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials

   • O. Akpoviroro
   • M. Castagne-Charlotin
   • M. A. Malikova

   Analytical Report 17 March 2023 Pages: 619 - 628

   

2. From Meaningful Outcomes to Meaningful Change Thresholds: A Path to Progress for Establishing Digital Endpoints

   • Marie Mc Carthy
   • Kate Burrows
   • Joseph C. Cappelleri

   Analytical Report 05 April 2023 Pages: 629 - 645

   

3. A Comparison of Instructions for Use Documents and Manufacturer Produced Administration Videos for Biological Products

   • Vraj Patel
   • Kellie Taylor
   • John Hertig

   Analytical Report 08 April 2023 Pages: 646 - 652

   

4. The Data Monitoring Committee: A Collective or a Collection?

   • Janet Wittes
   • Thomas Fleming
   • Charles Hennekens

   Commentary 17 April 2023 Pages: 653 - 655

5. EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age

   • Shannon Thor
   • Thorsten Vetter
   • Sandra Kweder

   Original Research Open access 04 March 2023 Pages: 656 - 661

   

6. An Extended Framework of Multiple Testing in Group Sequential Design

   • Man Jin
   • Pingye Zhang

   Original Research 16 March 2023 Pages: 662 - 670

   

7. Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US

   • Akio Maki
   • Mamoru Narukawa

   Original Research 25 March 2023 Pages: 671 - 677

   

8. Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru

   • Percy Herrera-Añazco
   • Diego Urrunaga-Pastor
   • Agueda Muñoz del Carpio Toia

   Original Research 28 March 2023 Pages: 678 - 688

9. Review of the Food and Drug Administration’s Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Mid-Cycle Communications

   • Richard D. Hoffman
   • Scott D. Beattie
   • Jillian Venci Fuhs

   Original Research 04 April 2023 Pages: 689 - 701

   

10. Adaptation of the WOMAC for Use in a Patient Preference Study

    • Sarah Stothers Rosenberg
    • Xinyi Ng
    • Martin Ho

    Original Research 15 April 2023 Pages: 702 - 711

    

11. Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers

    • Jessica Thompson
    • Molly Lynch
    • Micaela Brewington

    Original Research 15 April 2023 Pages: 712 - 716

12. Efficient Risk Mitigation Planning for a Clinical Trial

    • Vladimir Shnaydman

    Original Research 17 April 2023 Pages: 717 - 727

    

13. Comparison Between Simultaneous and Sequential Utilization of Safety and Efficacy for Optimal Dose Determination in Bayesian Model-Assisted Designs

    • Ran Li
    • Kentaro Takeda
    • Alan Rong

    Original Research 22 April 2023 Pages: 728 - 736

    

14. Factors Affecting Success of New Drug Clinical Trials

    • Eungdo Kim
    • Jaehoon Yang
    • Kwangsoo Shin

    Original Research 11 May 2023 Pages: 737 - 750

15. Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended

    • Gail B. Karet

    Original Research Open access 12 May 2023 Pages: 751 - 758

    

16. An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System

    • Sungju Kim
    • Ji Yeon Lee
    • Jong Hyuk Lee

    Original Research 14 May 2023 Pages: 759 - 768

    

17. Digital Tools—Regulatory Considerations for Application in Clinical Trials

    • Lian Gelis
    • Isabelle Stoeckert
    • Hans-Peter Podhaisky

    Original Research 17 May 2023 Pages: 769 - 782

    

18. The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study

    • Breda Kearney
    • Olivia McDermott

    Original Research Open access 17 May 2023 Pages: 783 - 796

    

19. Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries

    • David C. Higgins
    • Christian Johner

    Original Research 18 May 2023 Pages: 797 - 809

    

20. Horizon Scanning in Tissue Engineering Using Citation Network Analysis

    • Kouhei Otsuka
    • Takuya Takata
    • Mayumi Shikano

    Original Research Open access 18 May 2023 Pages: 810 - 822

    

21. Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol

    • Ziji Yu
    • Liwen Wu
    • Jianchang Lin

    Review 04 March 2023 Pages: 823 - 838

    

22. 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

    Review Open access 27 March 2023 Pages: 839 - 848

    

23. A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry

    • Tim Sullivan
    • Gyorgy Zorenyi
    • Magnus Nord

    Review Open access 01 April 2023 Pages: 849 - 864

    

24. Important Considerations for Signal Detection and Evaluation

    • James Buchanan
    • Mengchun Li

    Review Open access 17 April 2023 Pages: 865 - 874

    

25. Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners

    • Lauren T. Hotaki
    • Anu Shrestha
    • R. Angelo de Claro

    Review 18 April 2023 Pages: 875 - 885

26. Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

    • Binaya Sapkota
    • Subish Palaian
    • Mohamed Izham Mohamed Ibrahim

    Review Open access 27 April 2023 Pages: 886 - 898

    

27. Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned

    • Sunhee K. Ro
    • Weidong Zhang
    • Jing Zhao

    Review Open access 13 May 2023 Pages: 899 - 910