Regulatory Acceptance of Patient-Reported Outcome (PRO) Data from Bring-Your-Own-Device (BYOD) Solutions to Support Medical Product Labeling Claims Florence D. MowlemPamela TenaertsIngrid Oakley-Girvan Commentary Open access 09 May 2022 Pages: 531 - 535
Regulation of Drug Prescribing Information in Latin America and the Caribbean Mariana Ramírez-TellesUrimara Argotti-Rodríguez Review Open access 05 April 2022 Pages: 536 - 551
Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory Trials Weidong ZhangSunhee RoZhenzhen Xu Review 03 May 2022 Pages: 552 - 560
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 ZhouZhou LiuLingjing Hu Original Research 27 March 2022 Pages: 561 - 571
Unmet Therapeutic Needs of Non-Ambulatory Patients with Duchenne Muscular Dystrophy: A Mixed-Method Analysis Anne L. R. SchusterNorah L. CrossnohereJohn F. P. Bridges Original Research 24 March 2022 Pages: 572 - 586
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 SaekiTakuji KomedaHironori Sakai Original Research 30 March 2022 Pages: 587 - 595
Opportunities and Risks of UK Medical Device Reform Ji Eun Diana HanHussein IbrahimMelanie J. Calvert Original Research Open access 13 April 2022 Pages: 596 - 606
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training Stephen A. SonsteinElias SamuelsBarbara E. Bierer Original Research 31 March 2022 Pages: 607 - 615
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 KitabayashiYusuke Inoue Original Research 27 March 2022 Pages: 616 - 624
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 HasegawaSono SawadaYoshiaki Uyama Original Research Open access 18 April 2022 Pages: 625 - 631
Benchmarking Protocol Deviations and Their Variation by Major Disease Categories Kenneth GetzZachary SmithRandy Krauss Original Research 04 April 2022 Pages: 632 - 636
Marking 2-Years of New Thinking in Clinical Trials: The Estimand Journey C. FletcherN. HeftingA. Schueler Original Research 24 April 2022 Pages: 637 - 650
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 ZhangQingkao ZengYunjin Chen Original Research Open access 24 April 2022 Pages: 651 - 658
Randomized Controlled Trial Data for New Drug Application for Rare Diseases in Japan Yosuke KubotaMamoru Narukawa Original Research 27 April 2022 Pages: 659 - 666
False Negative ECG Device Results May Increase the Risk of Adverse Events in Clinical Oncology Trials Luc DekieRobert B. Kleiman Original Research Open access 26 April 2022 Pages: 667 - 676
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 YamataniHiroyuki SaekiHironori Sakai Original Research 12 May 2022 Pages: 677 - 684