1. Planning Benefit-Risk Assessments Using Visualizations

   • Michael W. Colopy
   • Lovemore Gakava
   • Chen Chen

   Analytical Report 08 September 2023 Pages: 1123 - 1135

   

2. Aiding the Adoption of Master Protocols by Optimizing Patient Engagement

   • Raymond A. Huml
   • Deborah Collyar
   • Jingjing Ye

   Analytical Report 24 August 2023 Pages: 1136 - 1147

3. Prioritizing Early Disease Intervention

   • H. Hugo Caicedo
   • Jonathan J. Darrow
   • Alex Pentland

   Commentary 05 September 2023 Pages: 1148 - 1152

4. Nature of the Interaction of Alpha-D-Mannose and Escherichia coli Bacteria, and Implications for its Regulatory Classification. A Delphi Panel European Consensus Based on Chemistry and Legal Evidence

   • Francesco Scaglione
   • Paola Minghetti
   • Huub Schellekens

   Review Open access 14 August 2023 Pages: 1153 - 1166

   

5. Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions

   • Pei Li
   • Su Wang
   • Yuwen Chen

   Review Open access 25 August 2023 Pages: 1167 - 1179

6. Global Postmarket Pharmacovigilance: A Generic Drug Perspective

   • Taylor Dalsey
   • Edward Kim
   • Sarah Ibrahim

   Review 10 August 2023 Pages: 1180 - 1189

   

7. Direct-to-Consumer Genetic Testing: A Comprehensive Review

   • Sharon Jiang
   • Lawrence Liberti
   • David Lebo

   Review 17 August 2023 Pages: 1190 - 1198

8. Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers

   • Virginia Acha
   • Bart Barefoot
   • Patrice Verpillat

   Original Research Open access 17 July 2023 Pages: 1199 - 1208

9. Is Your Organization’s Remote Work Strategy “Working”? Exploring the Impact of Employees’ Attitudes Toward Flexible Work Arrangements on Inclusion and Turnover Intention

   • Jennifer Kim
   • Abigail Dirks

   Original Research 17 July 2023 Pages: 1209 - 1216

   

10. Application of Statistical Methods for Central Statistical Monitoring and Implementations on the German Multiple Sclerosis Registry

    • Firas Fneish
    • David Ellenberger
    • Frank Schaarschmidt

    Original Research Open access 14 July 2023 Pages: 1217 - 1228

    

11. Defining Insights

    • Alicia A. Cadogan
    • Jerry Lau
    • Evelyn R. Hermes-DeSantis

    Original Research Open access 05 July 2023 Pages: 1229 - 1237

    

12. Statistical Evaluation of Responder Analysis in Stem Cell Clinical Trials

    • Jiajun Liu
    • Emily Poehlein
    • Shein-Chung Chow

    Original Research 09 August 2023 Pages: 1238 - 1247

    

13. Identification of Confusing Medicine Proprietary Names: Toward Safe Medicine Use—A Cross-Sectional Study in Sri Lanka

    • Manori Jayasinghe
    • Thotawaththage Loshadhi Indunika Srilal
    • Shukry Zawahir

    Original Research 17 August 2023 Pages: 1248 - 1259

    

14. A Mixed Methods Study to Explore Relevant Metrics for a Results Framework Measuring the Public Health Impact of Reliance-Based Pathways

    • Inez Adams
    • Patricia A. Cuff
    • Lawrence Liberti

    Original Research Open access 08 August 2023 Pages: 1260 - 1268

    

15. Digital Health Technologies in Clinical Trials: An Ontology-Driven Analysis to Inform Digital Sustainability Policies

    • Spencer Phillips Hey
    • Maria Dellapina
    • Jason LaRoche

    Original Research Open access 06 August 2023 Pages: 1269 - 1278

    

16. Landscape Analysis of Generic Availability for Oncologic Drugs

    • Vaibhav Kumar
    • Fenggong Wang
    • Liang Zhao

    Original Research 10 August 2023 Pages: 1279 - 1286

    

17. Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications

    • Urimara Argotti
    • Lada Leyens
    • Virginia Cozzi

    Original Research Open access 08 September 2023 Pages: 1287 - 1297

    

18. Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan

    • Yoko Aoi
    • Yuta Kato
    • Yoshiaki Uyama

    Original Research 16 August 2023 Pages: 1298 - 1303

    

19. Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video

    • Xinruo Zhang
    • Katherine Brind’Amour
    • Cynthia J. Girman

    Original Research Open access 17 August 2023 Pages: 1304 - 1313

    

20. Analysis on the Marketing Trend and Approval Lag of Imported Orphan Drugs from 2010 to 2021 in China

    • Feifei Peng
    • Hang Zheng

    Original Research 31 August 2023 Pages: 1314 - 1321