Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials O. AkpoviroroM. Castagne-CharlotinM. A. Malikova Analytical Report 17 March 2023 Pages: 619 - 628
From Meaningful Outcomes to Meaningful Change Thresholds: A Path to Progress for Establishing Digital Endpoints Marie Mc CarthyKate BurrowsJoseph C. Cappelleri Analytical Report 05 April 2023 Pages: 629 - 645
A Comparison of Instructions for Use Documents and Manufacturer Produced Administration Videos for Biological Products Vraj PatelKellie TaylorJohn Hertig Analytical Report 08 April 2023 Pages: 646 - 652
The Data Monitoring Committee: A Collective or a Collection? Janet WittesThomas FlemingCharles Hennekens Commentary 17 April 2023 Pages: 653 - 655
EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age Shannon ThorThorsten VetterSandra Kweder Original Research Open access 04 March 2023 Pages: 656 - 661
An Extended Framework of Multiple Testing in Group Sequential Design Man JinPingye Zhang Original Research 16 March 2023 Pages: 662 - 670
Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US Akio MakiMamoru Narukawa Original Research 25 March 2023 Pages: 671 - 677
Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru Percy Herrera-AñazcoDiego Urrunaga-PastorAgueda Muñoz del Carpio Toia Original Research 28 March 2023 Pages: 678 - 688
Review of the Food and Drug Administration’s Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Mid-Cycle Communications Richard D. HoffmanScott D. BeattieJillian Venci Fuhs Original Research 04 April 2023 Pages: 689 - 701
Adaptation of the WOMAC for Use in a Patient Preference Study Sarah Stothers RosenbergXinyi NgMartin Ho Original Research 15 April 2023 Pages: 702 - 711
Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers Jessica ThompsonMolly LynchMicaela Brewington Original Research 15 April 2023 Pages: 712 - 716
Efficient Risk Mitigation Planning for a Clinical Trial Vladimir Shnaydman Original Research 17 April 2023 Pages: 717 - 727
Comparison Between Simultaneous and Sequential Utilization of Safety and Efficacy for Optimal Dose Determination in Bayesian Model-Assisted Designs Ran LiKentaro TakedaAlan Rong Original Research 22 April 2023 Pages: 728 - 736
Factors Affecting Success of New Drug Clinical Trials Eungdo KimJaehoon YangKwangsoo Shin Original Research 11 May 2023 Pages: 737 - 750
Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended Gail B. Karet Original Research Open access 12 May 2023 Pages: 751 - 758
An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System Sungju KimJi Yeon LeeJong Hyuk Lee Original Research 14 May 2023 Pages: 759 - 768
Digital Tools—Regulatory Considerations for Application in Clinical Trials Lian GelisIsabelle StoeckertHans-Peter Podhaisky Original Research 17 May 2023 Pages: 769 - 782
The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study Breda KearneyOlivia McDermott Original Research Open access 17 May 2023 Pages: 783 - 796
Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries David C. HigginsChristian Johner Original Research 18 May 2023 Pages: 797 - 809
Horizon Scanning in Tissue Engineering Using Citation Network Analysis Kouhei OtsukaTakuya TakataMayumi Shikano Original Research Open access 18 May 2023 Pages: 810 - 822
Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol Ziji YuLiwen WuJianchang Lin Review 04 March 2023 Pages: 823 - 838
Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters Marion WolfsŁukasz BojarskiLinda B. Sullivan Review Open access 27 March 2023 Pages: 839 - 848
A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry Tim SullivanGyorgy ZorenyiMagnus Nord Review Open access 01 April 2023 Pages: 849 - 864
Important Considerations for Signal Detection and Evaluation James BuchananMengchun Li Review Open access 17 April 2023 Pages: 865 - 874
Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners Lauren T. HotakiAnu ShresthaR. Angelo de Claro Review 18 April 2023 Pages: 875 - 885
Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System Binaya SapkotaSubish PalaianMohamed Izham Mohamed Ibrahim Review Open access 27 April 2023 Pages: 886 - 898
Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned Sunhee K. RoWeidong ZhangJing Zhao Review Open access 13 May 2023 Pages: 899 - 910
