1. Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims

   • Florence D. Mowlem
   • Pamela Tenaerts
   • Ingrid Oakley-Girvan

   Commentary Open access 09 May 2022 Pages: 531 - 535

2. Regulation of Drug Prescribing Information in Latin America and the Caribbean

   • Mariana Ramírez-Telles
   • Urimara Argotti-Rodríguez

   Review Open access 05 April 2022 Pages: 536 - 551

3. Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory Trials

   • Weidong Zhang
   • Sunhee Ro
   • Zhenzhen Xu

   Review 03 May 2022 Pages: 552 - 560

   

4. Application of 3D Whole-Brain Texture Analysis and the Feature Selection Method Based on within-Class Scatter in the Classification and Diagnosis of Alzheimer’s Disease

   • Ke Zhou
   • Zhou Liu
   • Lingjing Hu

   Original Research 27 March 2022 Pages: 561 - 571

   

5. Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis

   • Anne L. R. Schuster
   • Norah L. Crossnohere
   • John F. P. Bridges

   Original Research 24 March 2022 Pages: 572 - 586

   

6. Estimation of a Suitable Number of Patients for Selective Safety Data Collection (ICH E19 Draft Guideline): When is the Safety Profile of a Drug Well Characterized?

   • Hiroyuki Saeki
   • Takuji Komeda
   • Hironori Sakai

   Original Research 30 March 2022 Pages: 587 - 595

7. Opportunities and Risks of UK Medical Device Reform

   • Ji Eun Diana Han
   • Hussein Ibrahim
   • Melanie J. Calvert

   Original Research Open access 13 April 2022 Pages: 596 - 606

   

8. Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

   • Stephen A. Sonstein
   • Elias Samuels
   • Barbara E. Bierer

   Original Research 31 March 2022 Pages: 607 - 615

9. Factors that Lead to Stagnation in Direct Patient Reporting of Adverse Drug Reactions: An Opinion Survey of the General Public and Physicians in Japan

   • Aki Kitabayashi
   • Yusuke Inoue

   Original Research 27 March 2022 Pages: 616 - 624

10. Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET^® Medical Information Database Network in Japan

    • Tomoaki Hasegawa
    • Sono Sawada
    • Yoshiaki Uyama

    Original Research Open access 18 April 2022 Pages: 625 - 631

    

11. Benchmarking Protocol Deviations and Their Variation by Major Disease Categories

    • Kenneth Getz
    • Zachary Smith
    • Randy Krauss

    Original Research 04 April 2022 Pages: 632 - 636

12. Marking 2-Years of New Thinking in Clinical Trials: The Estimand Journey

    • C. Fletcher
    • N. Hefting
    • A. Schueler

    Original Research 24 April 2022 Pages: 637 - 650

    

13. Risk Prediction of Central Nervous System Infection Secondary to Intraventricular Drainage in Patients with Intracerebral Hemorrhage: Development and Evaluation of a New Predictive Model Nomogram

    • Yanfeng Zhang
    • Qingkao Zeng
    • Yunjin Chen

    Original Research Open access 24 April 2022 Pages: 651 - 658

    

14. Randomized Controlled Trial Data for New Drug Application for Rare Diseases in Japan

    • Yosuke Kubota
    • Mamoru Narukawa

    Original Research 27 April 2022 Pages: 659 - 666

    

15. False Negative ECG Device Results May Increase the Risk of Adverse Events in Clinical Oncology Trials

    • Luc Dekie
    • Robert B. Kleiman

    Original Research Open access 26 April 2022 Pages: 667 - 676

    

16. How Many Clinical Trials Exist that Have Adopted Selective Safety Data Collection? NEJM Literature Search Results: The Possibility of Harmonizing the ICH E19 Guideline

    • Yuki Yamatani
    • Hiroyuki Saeki
    • Hironori Sakai

    Original Research 12 May 2022 Pages: 677 - 684