A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols Steven R. CummingsScott ChethamAndy Lee Analytical Report Open access 10 May 2024 Pages: 789 - 795
Regulatory Framework for Drug-Device Combination Products in the United States, Europe, and Korea Joo Hee KimSera KwonSu Dong Kim Review 08 May 2024 Pages: 796 - 806
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage Alper Fatih ArdicNurittin Ardic Review 16 May 2024 Pages: 807 - 816
Challenges and Lessons Learned in Autologous Chimeric Antigen Receptor T-Cell Therapy Development from a Statistical Perspective Daniel LiZhenzhen XuAlan Chiang Original Research 04 May 2024 Pages: 817 - 830
Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database Risa IwataShuichi MochizukiKatsura Tsukamoto Original Research 06 May 2024 Pages: 831 - 837
Good Statistical Monitoring: A Flexible Open-Source Tool to Detect Risks in Clinical Trials George WuSpencer ChildressJeremy Wildfire Original Research Open access 09 May 2024 Pages: 838 - 844
Simultaneous Global Drug Development and Multiregional Clinical Trials (MRCT): 5 Years After Implementation of ICH E17 Guidelines Rominder SinghWilliam WangYoshiaki Uyama Original Research 12 May 2024 Pages: 845 - 854
New Estimates on the Cost of a Delay Day in Drug Development Zachary P. SmithJoseph A. DiMasiKenneth A. Getz Original Research 21 May 2024 Pages: 855 - 862
Performance Evaluation of Interim Analysis in Bioequivalence Studies Naoki IsogawaAndy GrieveKazushi Maruo Original Research 24 May 2024 Pages: 863 - 881
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies Naoki IsogawaAndy GrieveKazushi Maruo Correction 10 June 2024 Pages: 882 - 882
The Impact of Serialisation on Operational Efficiency and Productivity in Irish Pharmaceutical Sites Daniel O’ MahonyAlan LynchOlivia McDermott Original Research Open access 29 May 2024 Pages: 883 - 896
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry Mary E WilhelmNancy Pire-SmerkanichFrances J Richmond Original Research Open access 31 May 2024 Pages: 897 - 909
EU’s Medical Device Expert Panels: Analysis of Membership and Published Clinical Evaluation Consultation Procedure (CECP) Results Colleen WatsonFrances J. Richmond Original Research Open access 10 June 2024 Pages: 910 - 916
A Systematic Review of Adaptive Seamless Clinical Trials for Late-Phase Oncology Development Kristine BroglioFreda CoonerPhilip He Research 11 June 2024 Pages: 917 - 929
Statistical Analysis for Rating Scale in Clinical Trials Mengyao ShiShein-Chung Chow Original Research 14 June 2024 Pages: 930 - 945
Overdosage Section in US and EU Labeling Sarah CondonThomas G. CantuJoanna Szewczyk Original Research Open access 17 June 2024 Pages: 946 - 952
Harmonizing Quality Improvement Metrics Across Global Trial Networks to Advance Paediatric Clinical Trials Delivery Sabah AttarAngie PriceRicardo M. Fernandes Original Research Open access 20 June 2024 Pages: 953 - 964
Patient and Public Perceptions in Canada About Decentralized and Hybrid Clinical Trials: “It’s About Time we Bring Trials to People” Dawn P. RichardsJohn QueenanSusan Marlin Original Research Open access 21 June 2024 Pages: 965 - 977
Use of Seamless Study Designs in Oncology Clinical Development– A Survey Conducted by IDSWG Oncology Sub-team Yingwen DongGautier PauxPhilip He Original Research 22 June 2024 Pages: 978 - 986
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health Emergency Marijo KambereHong VuJohn Concato Original Research Open access 24 June 2024 Pages: 987 - 995
Correction: Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials Abigail DirksMaria FlorezKenneth Getz Correction Open access 30 April 2024 Pages: 996 - 996