Why MASLD Trials Underselect the MENA Region Sites and What Sponsors and Regulators Must Change [0.03%]
为何中至重度哮喘临床试验忽视中东及北非地区研究机构以及申办方和监管者需要如何改变
Mohamed El-Kassas,Khalid M AlNaamani,Khalid Alswat et al.
Mohamed El-Kassas et al.
Metabolic dysfunction associated steatotic liver disease (MASLD) and metabolic dysfunction associated steatohepatitis (MASH) are accelerating global priorities, yet pivotal clinical trial activity remains concentrated in North America and E...
Clinicians' Reactions to Point-of-Care Advertising in Electronic Health Records [0.03%]
临床医生对电子健康记录中点对点护理广告的反应
Bethany L Tennant,Teresa Koenig,Sarah Bennett-Harper et al.
Bethany L Tennant et al.
Background: Pharmaceutical marketers have introduced novel ways to deliver point-of-care advertising to clinicians through their electronic health record systems (EHRs) workflow. However, there is a lack of research explo...
Adverse Events Associated with Clascoterone: A Real-World Pharmacovigilance Study of the Food and Drug Administration Adverse Event Reporting System [0.03%]
基于FDA不良事件报告系统的真实世界药物警戒研究中的克拉司特龙副作用监测
Li Tao,Mengying Zhang,Wenyue Zhang et al.
Li Tao et al.
Background: Clascoterone is a novel drug for the treatment of acne vulgaris (AV). To gain an improved comprehension of clascoterone safety in the real world, we conducted a disproportionality analysis based on data from t...
Present and Future Post-marketing Drug Safety Assessment in Japan: A PMDA Perspective [0.03%]
日本药品上市后安全性评价的现状与未来——PMDA视角
Takashi Waki,Shinya Watanabe,Takashi Ando et al.
Takashi Waki et al.
For pharmacovigilance, the Pharmaceuticals and Medical Devices Agency in Japan has utilized real world data (RWD) from multiple sources, including individual case safety reports, and medical information databases that capture routinely coll...
Web-based Dossier Management System (DMS) and Emerging Technologies to Facilitate Faster Registration and Access to Human Drugs: NAFDAC's Experience [0.03%]
基于网络的档案管理系统（DMS）和新兴技术可加快药品注册和便于获取：尼日利亚食品药品监督管理局的经验
Mojisola Christianah Adeyeye,Uche Sonny-Afoekelu,Edosa Ogbeide et al.
Mojisola Christianah Adeyeye et al.
The Dossier Management System (DMS) is an innovative web-based portal developed by the National Agency for Food and Drug Administration and Control (NAFDAC) for submitting product dossiers in Common Technical Documents (CTD) format to strea...
Missing Data Handling in the Application of Matching-Adjusted Indirect Comparison [0.03%]
匹配调整间接比较中缺失数据的处理方法研究
Yixin Fang,Moming Li,Jeff Lai et al.
Yixin Fang et al.
In support of Health Technology Assessment submission, we often need to conduct indirect treatment comparisons (ITC). One common type of ITC is population-adjusted indirect comparisons (Phillippo et al. in NICE DSU technical support documen...
Does the Epoch-Making Guideline Need Instructions for Use?: Analyzing Adverse Events Collected through Selective Safety Data Collection Under ICH E19 Guideline with Addressing Implementation Considerations [0.03%]
如何解读里程碑式指南：在实施中评价ICH E19安全信息收集指南的功效并提出改进建议
Hayato Niiyama,Takuji Komeda,Ayako Kitami et al.
Hayato Niiyama et al.
Purpose: The International Council of Harmonisation (ICH) E19 guideline (Step 5), which came into effect in 2023, does not specifically mention considerations in the planning phase or analysis methods in the data analysis...
Brian J Miller,Janet Woodcock
Brian J Miller
The article review the challenges and lack of robust biologics market competition and drug pricing impacts, the history of the small molecule generics marketplace and the subsequent early evolution of the biosimilar marketplace. The article...
Power Calculation for Non-inferiority Test Based on Linear Combination of Two Correlated Binary Endpoints [0.03%]
基于两个相关二分终点线性组合的非劣效性检验的功效计算方法研究
Haojia Song,Shein-Chung Chow
Haojia Song
In cancer research, multiple primary study endpoints, which may be correlated, are often considered. In practice, it is common to evaluate each clinical endpoint separately when performing sample size calculations. However, when the endpoin...