Totality of evidence of the effectiveness of repurposed therapies for COVID-19: Can we use real-world studies alongside randomized controlled trials? [0.03%]
关于将经再评价疗法用于治疗COVID-19有效性的证据的全面分析：能否结合真实世界研究和随机对照试验一起使用？
Jaap Mandema,Hugh Montgomery,Louis Dron et al.
Jaap Mandema et al.
Rapid and robust strategies to evaluate the efficacy and effectiveness of novel and existing pharmacotherapeutic interventions (repurposed treatments) in future pandemics are required. Observational "real-world studies" (RWS) can report mor...
Exploration of smart adherence-monitoring methods in vitamin D-deficient patients: A pilot feasibility clinical study [0.03%]
维生素D缺乏患者智能依从性监测方法的探索研究：一项可行性临床研究
Ki Young Huh,Hwiwon Lee,SeungHwan Lee et al.
Ki Young Huh et al.
Treatment adherence is an underestimated determinant of treatment success. Poor treatment adherence can also affect the efficacy of clinical trials. A combination of multiple adherence-monitoring methods is required to ensure robustness. We...
Randomized Controlled Trial
Clinical and translational science. 2023 Oct;16(10):1866-1875. DOI:10.1111/cts.13594 2023
Prevalence and utility of pharmacokinetic data in preclinical studies of mRNA cancer vaccines [0.03%]
mRNA癌症疫苗临床前研究中药代动力学数据的运用及适用性
Gillie A Roth,Bianca Vora,Chloe Kim et al.
Gillie A Roth et al.
In this brief report, we provide insights into current practices in preclinical messenger RNA (mRNA) cancer vaccine characterization. To enable a more automated and thorough survey of mRNA cancer vaccine data in the literature, we implement...
Clinical outcomes of generic versus brand-name clopidogrel for secondary prevention in patients with acute myocardial infarction: A nationwide cohort study [0.03%]
氯吡格雷仿制药与品牌药在急性心肌梗死二级预防中的临床疗效对比：一项全国队列研究
Cze Ci Chan,Ying-Chang Tung,Kuang-Tso Lee et al.
Cze Ci Chan et al.
Skepticism exists among healthcare workers and patients regarding the efficacy and safety of generic medication, despite its potential to lower healthcare costs. This study aimed to compare the outcomes of a generic clopidogrel and its bran...
Associations of HLA-C*01:02 and HLA-B*46:01 with regorafenib-induced erythema multiforme in Japanese patients with metastatic colorectal cancer [0.03%]
HLA-C*01:02和HLA-B*46:01等位基因与日本人转移性结直肠癌regorafenib诱导的多形性红斑相关性研究
Ken-Ichi Fujita,Natsumi Matsumoto,Remi Murase et al.
Ken-Ichi Fujita et al.
Regorafenib improves the survival of patients with metastatic colorectal cancer (mCRC); however, it is also characterized by detrimental dermal side effects that may require treatment cessation or modified dosing. In our previous prospectiv...
Factors explaining individual differences in the oral perception of capsaicin, l-menthol, and aluminum ammonium sulfate [0.03%]
辣椒素、薄荷醇和硫酸铝口腔感知的个体差异因素分析
Sulo Roukka,Sari Puputti,Heikki Aisala et al.
Sulo Roukka et al.
This research focused on the oral perception of naturally occurring chemical food compounds that are used in the pharma and food industries due to their pharmacological properties. They stimulate chemically sensitive receptors of the somato...
Comparison of variants in TPMT and NUDT15 between sequencing and genotyping methods in a multistate pediatric institution [0.03%]
TPMT和NUDT15基因在多州儿童机构中测序法与分型法的变异对比分析
Kelsey J Cook,Victoria Grusauskas,Lucy Gloe et al.
Kelsey J Cook et al.
The risk of severe adverse events related to thiopurine therapy can be reduced by personalizing dosing based on TPMT and NUDT15 genetic polymorphisms. However, the optimal genetic testing platform has not yet been established. In this study...
Comparative Study
Clinical and translational science. 2023 Aug;16(8):1352-1358. DOI:10.1111/cts.13539 2023
A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration [0.03%]
从Swissmedic、欧洲药品管理局和美国食品药品监督管理局的角度看抗癌产品和其他非抗癌产品的监管决策模式的十年对比变迁
Ulrich-P Rohr,Mario Iovino,Leonie Rudofsky et al.
Ulrich-P Rohr et al.
Consensus of regulatory decisions on the same Marketing Authorization Application (MAA) are critical for stakeholders. In this context, regulatory decision patterns from the Swissmedic (SMC), the US Food and Drug Administration (FDA), and t...
A phase I study comparing the pharmacokinetics and safety of HS628 (tocilizumab biosimilar) and reference tocilizumab in healthy male subjects [0.03%]
HS628（托珠单抗类似药）与参照用托珠单抗在健康男性受试者中的I期药代动力学和安全性的比较研究
Hongjie Qian,Jie Cheng,Yuzhou Gui et al.
Hongjie Qian et al.
This study aimed to evaluate the pharmacokinetic (PK) similarity of the proposed biosimilar HS628 compared with the reference tocilizumab (Actemra®) and also to demonstrate similar safety and immunogenicity profiles in healthy Chinese male...
Optimizing expert and patient input in pediatric trial design: Lessons learned and recommendations from a collaboration between conect4children and European Patient-CEntric ClinicAl TRial PLatforms [0.03%]
儿童试验设计中专家和患者输入的优化：conect4children与欧洲以患者为中心的临床试验平台合作的经验教训和建议
Britt A E Dhaenens,Fenna Mahler,Hannah Batchelor et al.
Britt A E Dhaenens et al.
Advice from multiple stakeholders is required to design the optimal pediatric clinical trial. We present recommendations for acquiring advice from trial experts and patients/caregivers, derived from advice meetings that were performed throu...