Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph + ALL with Immature Efficacy Data [0.03%]
基于患者视角的利弊评估在临床试验中的挑战——以Ph+ALL为例
Ajibade Ashaye,Caitlin Thomas,Vamsi Kota et al.
Ajibade Ashaye et al.
Quantitative benefit-risk assessment (qBRA) can reveal how patients balance benefits and risks of cancer treatments. To align with qBRA good practice guidelines, researchers must address challenges including attribute value dependence, doub...
Incorporating Patient Perspectives into Structured Benefit-Risk Assessment: A Drug Development Framework Recommendation [0.03%]
从患者角度进行结构化利弊评估：新药研发框架建议
Emuella Flood,Niklas Karlsson,Jennifer Ostridge et al.
Emuella Flood et al.
Regulatory agencies have been promoting the incorporation of the patient perspective into benefit-risk assessment to better align regulatory decisions with patients' needs and priorities. Currently, benefit-risk assessments for regulatory s...
Challenges and Potential Solutions to Advance Global Cancer Drug Development [0.03%]
推进全球抗癌药物研发的挑战与潜在解决方案
Axel Glasmacher,Kim Lyerly,Birgit Wolf et al.
Axel Glasmacher et al.
Despite recent advancements in oncology drug development, patient access to innovative cancer therapies remains inadequate. There is an urgent need for more patient-centric approaches, with meaningful patient input from trial design through...
Assessing the Contribution of Components in Late-Phase Oncology Trials: A Roadmap of Key Approaches [0.03%]
评估晚期肿瘤试验中各组成要素贡献的价值：关键方法路线图分析
Xiaowen Tian,Kristine Broglio,Di Ran et al.
Xiaowen Tian et al.
Systematic Review of Patient Focused Drug Development Meeting Reports for Conditions Affecting Neurodevelopment [0.03%]
针对影响神经发育疾病的以患者为中心的药物开发会议报告系统评价
Cristan Farmer,Victoria Kim,Tanvi Das et al.
Cristan Farmer et al.
Background: Researchers of rare diseases affecting neurodevelopment struggle with concept and outcome assessment identification issues that are uniquely associated with developmental concepts but common across conditions....
Mapping the evolution of cell and gene therapy product research: trends, collaborations, and emerging frontiers [0.03%]
绘制细胞和基因治疗产品研究的发展地图：趋势、合作和新兴前沿
Yanmei Rao,Li Dong,Zhe Huang
Yanmei Rao
Advanced therapeutic medicinal products represent a broad spectrum of biopharmaceutical innovations that prominently feature cell and gene therapy formulations. These cutting-edge therapeutic modalities are specifically engineered to interv...
Madhumitha Masilamani,Melvin George
Madhumitha Masilamani
Digital therapeutics (DTx) are emerging as a transformative approach in healthcare, offering software-driven, evidence-based interventions for the prevention, management, and treatment of medical conditions such as chronic diseases, mental ...
Applications and Challenges of Artificial Intelligence and Big Data in Drug Regulation [0.03%]
人工智能与大数据在药物监管中的应用及挑战
Zhao Liu,Yang Zheng,Jun Fang et al.
Zhao Liu et al.
Artificial intelligence (AI) and big data are increasingly applied in drug regulation and have demonstrated significant potential worldwide. The U.S. Food and Drug Administration (FDA) has developed a relatively comprehensive approach throu...
Metformin as an Adjunct in Periodontal Therapy: Mechanistic Insights, Research Evidence and Current Challenges [0.03%]
二甲双胍在牙周治疗中的辅助作用：机制见解、研究证据及当前挑战
Hamza Alasbily,Muna Saad Elburki
Hamza Alasbily
Periodontal disease is a chronic inflammatory disorder that gradually destroys tooth-supporting tissues including the alveolar bone, periodontal ligament, and cementum. In recent years, interest has grown in repurposing metformin, a well-kn...
The UK's 2026 Clinical Trial Regulations: A Strategic Analysis for Global Pharmaceutical Sponsors [0.03%]
英国2026年临床试验法规：全球制药企业的战略分析
Amer Alghabban
Amer Alghabban
The United Kingdom is undertaking the most significant reform of its clinical trials legislation in two decades with The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. Set to come into full effect on 28 April 2026, ...