Strategic Integration of Companion Diagnostics in Precision Oncology: Key Factors, Drug Development Timelines, and Regulatory Insights from U.S. FDA Approvals [0.03%]
精准肿瘤学中伴随诊断的战略整合：美国FDA批准的关键因素、药物开发时间线和监管启示
Kaku Saito,Mamoru Narukawa
Kaku Saito
Background: Companion diagnostics (CDxs) are central to precision oncology, enabling identification of patients most likely to benefit from targeted therapies. Their quantitative impact on anticancer drug development time...
Regulatory Approaches to Electronic Labelling in the USA, EU, and India: A Comparative Overview [0.03%]
美国、欧盟和印度电子标签的监管方法比较概述
Komal Saini,Ramandeep Singh
Komal Saini
Objective: In this era of growth, e-labelling is becoming increasingly important as the labels are important sources of information for patients. However, regulations governing e-labeling for pharmaceuticals and medical e...
Research on the Quality Evaluation Indicators of Real-World Data in the Review of Anti-Tumor Drugs for Chinese Regulatory Frameworks [0.03%]
中国监管框架下抗肿瘤药物真实世界数据审评质量评价指标研究
Jie-Ying Zhang,Yong Tang,Fang-Zheng Dong et al.
Jie-Ying Zhang et al.
Background: This study addresses the quality of real-world data (RWD) in oncology and proposes a comprehensive evaluation system for assessing the quality of RWD in the review of anti-tumor drugs. The proposed system prov...
Statistical Guardrails for Hybrid-Controlled Trials: Robust to Confounding and Between-Study Heterogeneity [0.03%]
混合控制试验的统计容差范围：对混杂和研究间异质性具有鲁棒性
Di Ran,Fanni Zhang,Kristine Broglio et al.
Di Ran et al.
External evidence from prior trials, registries, and fit-for-purpose real-world data can improve drug development efficiency. Hybrid-controlled designs are particularly appealing for reducing concurrent control enrollment while simultaneous...
Letter to the Editor: Battle Won but War Lost for Barth Syndrome Patients [0.03%]
读者来信：巴尔特定症患者赢得一场战役但输掉了一场战争
Norman Stockbridge,Mary Ross Southworth
Norman Stockbridge
Impurities in Oncology Pharmaceuticals: A Review of Classification, Detection Methods, Regulatory Frameworks and Emerging Trends [0.03%]
抗癌药物中的杂质：分类、检测方法、监管框架及新兴趋势的综述
Kishan Balehalli Shivananda,Nagarjun Somaprakash,Pradeep Kumar Badiya
Kishan Balehalli Shivananda
Pharmaceutical impurities pose a significant challenge in the development and manufacturing of anti-cancer drugs due to their high potency, narrow therapeutic index, and prolonged administration in most treatment regimens. Even trace-level ...
An NCI Micro-credentialing Model for Onboarding and Training Clinical Research Professionals in a Lean Fiscal Environment [0.03%]
NCI精简财务环境下的临床研究专业人员入职和培训微证书模型
Barbara Tafuto,Belinda Zhang,Kathleen Black et al.
Barbara Tafuto et al.
Clinical research professionals are essential to the successful conduct of clinical trials yet training and retention of this workforce remain significant challenges, particularly with constrained budgets and declining indirect cost reimbur...
Enhancing Data Quality in Clinical Trials: Cross-Company Validation of the Open-Source Clinical Trial Anomaly Spotter (CTAS) [0.03%]
临床试验中的数据质量改进：开源临床试验异常检测器（CTAS）的跨公司验证
Pekka Tiikkainen,Frederik Collin,Björn Koneswarakantha
Pekka Tiikkainen
Background: Current ICH guidelines, e.g. ICH E6 (R3), advocate a risk-based statistical review of clinical trial data to identify anomalies. The open-source R package, clinical trial anomaly spotter (CTAS) has been develo...
Ethical Challenges and Considerations in Decentralized Clinical Trials (DCTs): Insights from a Scoping Review [0.03%]
去中心化临床试验的伦理挑战与考量——来自系统综述的见解
Lijia Han,Kai Hong Ooi,Krisna Veni Balakrishnan et al.
Lijia Han et al.
Background: Decentralized clinical trials (DCTs) leverage digital health technologies to conduct trials outside traditional settings, offering numerous benefits such as increased participant diversity and breaking down ge...
Courtney McGuire,Jenn W Sellers,Cheryl Grandinetti et al.
Courtney McGuire et al.