1. Bayesian Clinical Trials

   • Jennifer Clark
   • Natalia Muhlemann
   • Alexei Ionan

   Educational Review 31 January 2023 Pages: 399 - 400

2. Correction to: Bayesian Clinical Trials

   • Jennifer Clark
   • Natalia Muhlemann
   • Alexei Ionan

   Correction 06 April 2023 Pages: 401 - 401

3. A Tutorial on Modern Bayesian Methods in Clinical Trials

   • Natalia Muehlemann
   • Tianjian Zhou
   • Estelle Russek-Cohen

   Educational Review 20 April 2023 Pages: 402 - 416

   

4. Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development

   • The Medical Outreach Subteam of the Drug Information Association Bayesian Scientific Working Group
   • Jennifer Clark
   • Ross Bray

   Analytical Report 03 January 2022 Pages: 417 - 425

   

5. Why are There not More Bayesian Clinical Trials? Ability to Interpret Bayesian and Conventional Statistics Among Medical Researchers

   • The Medical Outreach Team of the Drug Information Association Bayesian Scientific Working Group
   • Ross Bray
   • Jennifer Clark

   Original Research 10 December 2022 Pages: 426 - 435

   

6. Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER

   • Alexei C. Ionan
   • Jennifer Clark
   • Mark Rothmann

   Review 02 December 2022 Pages: 436 - 444

   

7. Bayesian Strategies in Rare Diseases

   • Ursula Garczarek
   • Natalia Muehlemann
   • Estelle Russek-Cohen

   Review 24 December 2022 Pages: 445 - 452

8. Bayesian Statistics for Medical Devices: Progress Since 2010

   • Gregory Campbell
   • Telba Irony
   • Laura Thompson

   Review 03 March 2023 Pages: 453 - 463

9. Some Thoughts on the Use of Predictive Probability in Clinical Trials

   • Heng Li
   • Manuela Buzoianu
   • Xu Yan

   Commentary 11 January 2023 Pages: 464 - 466

10. Sensitivity Analysis for Restricted Mean Survival Time When Survival Curves Have Divergent Tails

    • Kentaro Ueno
    • Satoshi Morita

    Commentary 03 January 2023 Pages: 467 - 471

    

11. Examining Endpoint Concordance in Clinical Trials and Real-World Clinical Practice to Advance Real-World Evidence Utilization

    • Debra Schaumberg
    • Kay Larholt
    • Gigi Hirsch

    Commentary 09 January 2023 Pages: 472 - 475

    

12. Efficacy and Safety of Ophthalmic Preparations of Glucocorticoids in Patients with Epidemic Keratoconjunctivitis: A Systematic Review and Meta-analysis

    • Pengpeng Liu
    • Guangyao Li
    • Chao Zhang

    Review 22 November 2022 Pages: 476 - 483

    

13. Regulatory Pathways Supporting Expedited Drug Development and Approval in ICH Member Countries

    • Pedro Franco
    • Ritesh Jain
    • Marén U. Koban

    Review Open access 03 December 2022 Pages: 484 - 514

14. Challenges in Implementing Futility Schemes, with Reference to Aducanumab

    • Paul Gallo
    • Satrajit Roychoudhury

    Review 03 February 2023 Pages: 515 - 520

15. Accurate Collection of Reasons for Treatment Discontinuation to Better Define Estimands in Clinical Trials

    • Yongming Qu
    • Robin D. White
    • Stephen J. Ruberg

    Analytical Report 21 December 2022 Pages: 521 - 528

    

16. Risk-Based Monitoring in Clinical Trials: 2021 Update

    • Amy Adams
    • Anina Adelfio
    • Debby Brown

    Analytical Report Open access 09 January 2023 Pages: 529 - 537

    

17. Analysis of Off-target Effects and Risk Assessment Leading from Preclinical to Clinical Trials of Gene-edited Therapeutic Products

    • Naoki Yamada
    • Atsushi Aruga

    Original Research 24 November 2022 Pages: 538 - 551

    

18. Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020

    • Hyeyoung Choi
    • Hyesung Lee
    • Jaehyun Lee

    Original Research Open access 20 December 2022 Pages: 552 - 560

    

19. Awareness of Clinical Research Coordinators Toward Ethics and Protection of Clinical Trial Patients

    • Zhen Peng
    • Yan Ma
    • Yin Chen

    Original Research 26 December 2022 Pages: 561 - 569

20. Changes in Medication Use During Pregnancy for Women with Chronic Conditions: An Analysis of Claims Data

    • Rohini K. Hernandez
    • Sonja S. Nakasian
    • Victoria Chia

    Original Research 23 December 2022 Pages: 570 - 579

    

21. A Flexible Ensemble Learning Method for Survival Extrapolation

    • Ran Dai
    • Jihyun Ma
    • Weili He

    Original Research 19 December 2022 Pages: 580 - 588

    

22. Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance

    • Yijun Ren
    • Michele Bertoldi
    • Enrico Gianluca Caiani

    Original Research Open access 18 January 2023 Pages: 589 - 602

    

23. Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical Trials

    • Shinya Watanabe
    • Takahiro Nonaka
    • Eiichi Ishikawa

    Original Research 05 January 2023 Pages: 603 - 610

    

24. An Improved Matching Practice for Augmenting a Randomized Clinical Trial with External Control

    • Jianghao Li
    • Yu Du
    • Yanyao Yi

    Original Research 21 February 2023 Pages: 611 - 618