Correction: Advanced Regenerative Medicines for Rare Diseases: A Review of Industry Sponsors Investment Motivations Ubaka OgboguAnja Nel Publisher Correction Open access 16 September 2024
A Framework for the Use and Likelihood of Regulatory Acceptance of Single-Arm Trials Disha SubramaniamColin Anderson-SmitsCynthia Girman Review Open access 16 September 2024
Latest Developments in “Adaptive Enrichment” Clinical Trial Designs in Oncology Yue TuLindsay A. Renfro Review Open access 13 September 2024
Advanced Regenerative Medicines for Rare Diseases: A Review of Industry Sponsors Investment Motivations Ubaka OgboguAnja Nel Review Open access 10 September 2024
Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment Lu WangNegar GolchinGeoffrey Gipson Analysis Open access 06 September 2024
Delta Inflation, Optimism Bias, and Uncertainty in Clinical Trials Charles C. LiuPeiwen WuRon Xiaolong Yu Review 06 September 2024
Using a Quality Management System and Risk-based Approach in Observational Studies to Obtain Robust Real-World Evidence Reo TanoshimaNaoko InagakiEtsuko Miyagi Analysis 03 September 2024
Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data Katarina HedmanGeorge KordzakhiaPer Nyström Research 31 August 2024
Insights into Early Interactions on Innovative Developments with European Regulators David W. UsterValentina Cordo’Falk Ehmann Research Open access 30 August 2024
Current Application of the Medical Device Single Audit Program (MDSAP) as a Global Regulatory Reliance Framework for the Inspection of Medical Devices Kenichi IshibashiMasuo KondohTetsuya Kusakabe Review 30 August 2024
A Global Industry Survey on Post-Approval Change Management and Use of Reliance Andrew DeavinAliyah HossainCéline Bourguignon Research 23 August 2024
On the Application of Artificial Intelligence/Machine Learning (AI/ML) in Late-Stage Clinical Development Karl KöchertTim FriedeElena Rantou Original Research 21 August 2024
Public Perspectives on Direct-to-Consumer Testing Oversight Sharon JiangDavid LeboThomas Schultz Comment 17 August 2024
RegionSizeR– A Novel App for Regional Sample Size Planning in MRCTs Guannan SunXin SunXiaowei Ren Research Open access 08 August 2024
Publisher Correction: Capacity Assessment of the National Medicines Regulatory Authority in a Low -Income Country Fawzi ThomasOnome T. AbiriOlufunsho Awodele Publisher Correction 07 August 2024
Leveraging Real-World Data in Safety Signal Assessment Vaishali PatadiaKatrin ManlikStephanie von Klot Research Open access 06 August 2024
Capacity Assessment of the National Medicines Regulatory Authority in a Low -Income Country Fawzi ThomasOnome T. AbiriOlufunsho Awodele Research 04 August 2024
A Comprehensive Framework for Evaluating the Value Created by Real-World Evidence for Diverse Stakeholders: The Case for Coordinated Registry Networks Laura Elisabeth GresslerDanica Marinac-DabicGregory Pappas Research 25 July 2024
Draft Guideline for Industry to Manage Drug Shortages in Japan Hiroaki MamiyaKen-ichi IzutsuDaichi Mitani Comment 24 July 2024
Unleashing the Power of Reliance for Post-Approval Changes: A Journey with 48 National Regulatory Authorities Francesca MangiaYameng (Melly) LinSusanne Ausborn Analysis Open access 24 July 2024
Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in Oncology Hiroko YaegashiYukikazu HayashiTakuhiro Yamaguchi Original Research Open access 02 July 2024
Mutagenic Azido Impurities in Drug Substances: A Perspective Sumit S. ChourasiyaDeepika KathuriaKamlesh J. Ranbhan Review 01 July 2024
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
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
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
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
Overdosage Section in US and EU Labeling Sarah CondonThomas G. CantuJoanna Szewczyk Original Research Open access 17 June 2024 Pages: 946 - 952
Statistical Analysis for Rating Scale in Clinical Trials Mengyao ShiShein-Chung Chow Original Research 14 June 2024 Pages: 930 - 945
A Systematic Review of Adaptive Seamless Clinical Trials for Late-Phase Oncology Development Kristine BroglioFreda CoonerPhilip He Research 11 June 2024 Pages: 917 - 929
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
Correction to: Performance Evaluation of Interim Analysis in Bioequivalence Studies Naoki IsogawaAndy GrieveKazushi Maruo Correction 10 June 2024 Pages: 882 - 882
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
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
Performance Evaluation of Interim Analysis in Bioequivalence Studies Naoki IsogawaAndy GrieveKazushi Maruo Original Research 24 May 2024 Pages: 863 - 881
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
Role of Neutrophils as Therapeutic Targets in Intracerebral Hemorrhage Alper Fatih ArdicNurittin Ardic Review 16 May 2024 Pages: 807 - 816
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
Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials Zachary SmithKenneth Getz Original Research 11 May 2024
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
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
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
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
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
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
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies Zhi-Hui SongQiao-Ming HuangChao Zhang Original Research 29 April 2024 Pages: 773 - 787
Implementing Decentralized Clinical Trials in Australia through Teletrials: Where to From Here? Tanya SymonsAnne WoollettLisa Eckstein Commentary Open access 29 April 2024
Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape? Hans-Peter Podhaisky Commentary 24 April 2024 Pages: 610 - 613
Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology Akio MakiMamoru Narukawa Original Research 23 April 2024 Pages: 766 - 772
Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics Yimei LiRobert NelsonJingjing Ye Review Open access 23 April 2024 Pages: 634 - 644