1. Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa

   • Armel Zemsi
   • Lorraine Jinette Guedem Nekame
   • Umberto D’Alessandro

   Analytical Report Open access 29 January 2024 Pages: 395 - 403

2. Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework

   • Michael Torok
   • Leslie Sam
   • Jennifer Hebert

   Analytical Report Open access 07 February 2024 Pages: 404 - 414

   

3. Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

   • Sai Dharmarajan
   • Zhong Yuan
   • Ram Tiwari

   Analytical Report 24 January 2024 Pages: 415 - 422

   

4. Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting

   • Annett Keller
   • Nathalie van Borrendam
   • Jun Liu

   Analytical Report 06 February 2024 Pages: 423 - 430

   

5. The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data

   • Heng Li
   • Wei-Chen Chen
   • Yu Zhao

   Letter to the Editor 26 March 2024 Pages: 431 - 432

6. Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability

   • Anders Vinther
   • Emma Ramnarine
   • David Fryrear

   Review Open access 18 February 2024 Pages: 433 - 442

   

7. The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data

   • Kelly H. Zou
   • Chelsea Vigna
   • Jim Z. Li

   Review Open access 25 March 2024 Pages: 443 - 455

   

8. The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today

   • Karen Zhou
   • Ginny Gattinger

   Review Open access 25 March 2024 Pages: 456 - 464

9. The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power

   • Rong Tang
   • Wei-Chen Chen
   • Yu Zhao

   Original Research Open access 05 February 2024 Pages: 465 - 472

   

10. A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies

    • Bernadette Johnson-Williams
    • Kellie Reynolds
    • Albert Rundio

    Original Research Open access 06 February 2024 Pages: 473 - 482

    

11. Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials

    • Sylviane de Viron
    • Laura Trotta
    • Marc Buyse

    Original Research Open access 09 February 2024 Pages: 483 - 494

    

12. Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework

    • Rima Izem
    • Emmanuel Zuber
    • Robert Hemmings

    Original Research 05 February 2024 Pages: 495 - 504

    

13. Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe

    • Colleen Davenport
    • Patricia Gravel
    • Bruce Mitlak

    Original Research Open access 10 February 2024 Pages: 505 - 518

    

14. Correction: Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

    • Sai Dharmarajan
    • Zhong Yuan
    • Ram Tiwari

    Correction 12 February 2024 Pages: 519 - 519

15. Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials

    • Abigail Dirks
    • Maria Florez
    • Kenneth Getz

    Original Research Open access 16 February 2024 Pages: 520 - 527

16. Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia

    • Wan Lee Chow
    • Nur Afiqah Mohd Salleh
    • Tse Siang Kang

    Original Research 20 February 2024 Pages: 528 - 538

    

17. New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance

    • Kenneth Getz
    • Zachary Smith
    • Arnaud Dauchy

    Original Research 04 March 2024 Pages: 539 - 548

18. A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy

    • Fernanda Lacerda da Silva Machado
    • Martín Cañás
    • Luciane Cruz Lopes

    Original Research 04 March 2024 Pages: 549 - 556

    

19. Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations

    • Gaia Geraci
    • Robert Smith
    • Tse Siang Kang

    Original Research Open access 08 March 2024 Pages: 557 - 566

    

20. Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry

    • Nicholette Conway
    • Orin Chisholm

    Original Research Open access 15 March 2024 Pages: 567 - 577