How Digital Health Technologies have been Used to Support Regulatory Drug Approval [0.03%]
数字健康技术如何被用于支持监管药物审批
Agathe Thierry,Antoine Manson,Hans-Peter Podhaisky
Agathe Thierry
Objective: The integration of Digital Health Technologies (DHTs) in clinical trials enhances patient recruitment, streamlines data collection, and provides new endpoints. However, a complex regulatory environment limits t...
Application of the Child-Pugh Classification in Japanese Drug Labeling: A Cross-Sectional Analysis of Contraindications, Dose Recommendations, and Pharmacokinetic Rationale [0.03%]
儿童-Pugh分类在日本药品说明书中的应用：禁忌症、剂量建议和药代动力学依据的横断面分析
Masahiro Kobayashi,Moeka Ogawa,Tatsuya Okuwaki et al.
Masahiro Kobayashi et al.
Objective: To systematically evaluate how the Child-Pugh classification is applied in Japanese prescription drug labeling and to characterize the pharmacokinetic features and evidentiary basis underlying contraindications...
Two Decades of Progress and Remaining Challenges: Comparative Analysis of Rare Disease Policy Implementation in Bulgaria, Romania, and Greece [0.03%]
二十年的进展与 remaining challenges：保加利亚、罗马尼亚和希腊罕见病政策实施的比较分析
Iva Nenkova,Petya Pavlikyanova,Adina Turcu-Stiolica et al.
Iva Nenkova et al.
Background: Rare diseases (RDs) pose significant challenges to public health, affecting millions of individuals across the world. Since the adoption of Regulation (EC) No. 141/2000, the European Union (EU) has provided a ...
Association Between FDA Drug Recall Classification and Product-Related Characteristics [0.03%]
美国食品药品管理局药物召回级别与药品特征的关系分析
Lantider K Bekele,M Affan Badar,Christopher J Kluse
Lantider K Bekele
Purpose: This study examined associations between FDA drug recall classification (Class I-III) and selected product-related characteristics using publicly available recall data. ...
Oliver Keene,Helle Lynggaard,Christine Fletcher et al.
Oliver Keene et al.
The ICH E9(R1) estimands framework requires precise specification of the treatment effects (estimands) a trial is designed to estimate. A recent article by Troxel et al. [1] has advanced a narrow view that only estimands using the treatment...
Medicinal Chemistry Perspectives on Drug Repurposing: Innovative Approaches and Therapeutic Breakthrough [0.03%]
药物再利用的医药化学视角：创新方法和治疗突破
Sapna Ahuja,Divya Kanwar,Pragati Silakari et al.
Sapna Ahuja et al.
Drug repurposing involves the discovery of new therapeutic uses of existing drugs that have already been approved by the regulatory authorities. It provides an alternative with more efficient approaches to traditional drug discovery, levera...
Nathalie van Borrendam,Annett Keller,Leon Els et al.
Nathalie van Borrendam et al.
QTLs aim to ensure that the impact of risks on critical quality aspects of the trial remains within an acceptable range. Action limits can serve as an effective mechanism for the early detection of potential risks, emphasizing the importanc...
Implementing Project Optimus in Oncology Dosage Optimization: Where are We Now? [0.03%]
优化肿瘤药物剂量的Project Optimus实施进展如何？
Revathi Ananthakrishnan,Patrick Mitchell,Dong Xi et al.
Revathi Ananthakrishnan et al.
Determining the optimal dosage of oncology drugs is a critical component of drug development, as many anticancer agents are associated with high toxicity. With the emergence of targeted therapies and immunotherapies, the conventional concep...
Validation of the Ontario Protocol Assessment Level (OPAL) Tool for Assessing Clinical Trial Complexity and Supporting Workforce Planning in the Italian Clinical Research Context [0.03%]
评估安大略协议评估水平（OPAL）工具在意大利临床研究背景下评估临床试验复杂性和支持 workforce planning 的有效性
Daniele Napolitano,Mattia Bozzetti,Rosario Caruso et al.
Daniele Napolitano et al.
Introduction: The growing complexity of clinical trials, particularly in oncology, has significantly increased the operational burden on research staff. However, standardized and validated instruments to measure trial-rel...
The Effect of Covariate Adjustment for Cox Regression in Cardiovascular Outcome Trials [0.03%]
Cox回归法在心血管终点事件试验中的协变量调整效应
Alexander Przybylski,Björn Holzhauer,Simon Wandel
Alexander Przybylski
Adjustment for prognostic baseline covariates is routinely used to increase power in randomized controlled trials. Yet, time-to-event outcomes are commonly analyzed using the log-rank test or Cox regression with no covariates besides treatm...