Precision in Pharmacoeconomics: A Comparative Cost-Utility Analysis of Osimertinib in EGFR-Mutant NSCLC Using Traditional and Pharmacometric Models [0.03%]
精准药物经济学：使用传统和药理学模型对EGFR突变NSCLC中奥希替尼的比较成本效用分析
Gloria Nnadwa Alhassan
Gloria Nnadwa Alhassan
Health technology assessments (HTAs) for targeted therapies like osimertinib require models capturing individual pharmacokinetic/pharmacodynamic (PK/PD) variability in epidermal growth factor receptor (EGFR)-mutant non-small cell lung cance...
Ethical and Regulatory Awareness of Clinical Trials: A Nationwide Cross-Sectional Study from Poland [0.03%]
来自波兰的全国性横断面研究：临床试验的伦理和监管意识
Damian Swieczkowski,Jacek Burzyński,Aleksander Kwaśny et al.
Damian Swieczkowski et al.
Background: Clinical trials are conducted under rigorous ethical and regulatory frameworks to protect participants, including ethics committee approval, informed consent, oversight, and personal data protection. However, ...
RWE Submission for European Regulators and Payers: Challenges, Uncertainties, and Opportunities [0.03%]
德国意昂集团：挑战、不确定性及机遇
Lockwood Taylor,Blythe Adamson
Lockwood Taylor
The new European Union Joint Clinical Assessment (JCA) process, effective January 2025, requires pharmaceutical companies to submit evidence within 100 days of notification. Key challenges include uncertainty about PICO (Population, Interve...
Bioequivalence of Generic Semi-solid Topical Dermatological Drug Products: Scientific and Regulatory Perspective from Japan's 2025 Guidelines [0.03%]
日本2025年指导原则下的半固体制剂仿制药的生物等效性：科学和监管观点
Hiroyuki Yoshida,Yasuhiro Abe,Miho Kasuga et al.
Hiroyuki Yoshida et al.
This review examines Japan's 2025 revision of bioequivalence (BE) guidelines for semi-solid topical dermatological drug products as a case study in regulatory science, focusing on how accumulated scientific evidence has been translated into...
Use of Information Technology to Mitigate Protocol Deviations in Clinical Research: A Quality Improvement Project [0.03%]
临床研究中利用信息技术减轻操作偏差的质量改进项目
Kathryn E Hall,Jean M Bernhardt
Kathryn E Hall
Introduction: Accurate vital sign (VS) documentation is essential in clinical research to ensure participant safety and data integrity. However, protocol deviations related to VS transcription and documentation remain a p...
Application of Artificial Intelligence in MedDRA Coding: A Practical Exploration from Clinical Data Management Perspective [0.03%]
人工智能在医学词典编码中的应用：临床数据管理视角下的初步探索
Charles Yan,Ruier Yang,Huaihai Yan et al.
Charles Yan et al.
Background: Traditional manual MedDRA coding in clinical data management (CDM) faces persistent challenges, including suboptimal site data quality, terminology complexity, low efficiency, inconsistent outcomes, frequent d...
Advancing Platform Trials in Early Oncology by Using MATS and EXNEX in Randomized Controlled Trials [0.03%]
借助随机对照试验中的MATS和EXNEX推进早期肿瘤平台试验的发展
Zhe Chen,Gu Mi,Ji Lin
Zhe Chen
The randomized controlled trial (RCT) is widely regarded as the gold standard in clinical development due to its ability to support robust statistical inference. In early-phase oncology development, however, trialists and statisticians may ...
CARE Framework for Inclusive Clinical Studies: An Evidence-Based Approach for and Measurement of Recruitment and Retention of Black Women in Breast Cancer Research [0.03%]
乳腺癌研究中纳入黑人女性的临床研究包容性框架（CARE）：一种基于证据的方法及其招募和保留的测量方法
Shreya N Sarathy,Leslie Sam,Melva T Covington
Shreya N Sarathy
Incredible breakthroughs in scientific discoveries for the treatment of breast cancer have led to rapid improvements in health outcomes and quality of life for patients seeking healthcare solutions. However, the lack of inclusion of patient...
Parents' Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences [0.03%]
欧洲跨境罕见病临床试验的语言可及性与患者偏好——来自家长的视角
Begonya Nafria,Segolene Gaillard,Martine Dehlinger-Kremer et al.
Begonya Nafria et al.
Introduction: Access to cross-border clinical trials may represent the sole therapeutic option for children living with rare diseases for which no approved medicines exist. Many children are excluded from participation in...