Precision medicine in regulatory decision making: Biomarkers used for patient selection in European Public Assessment Reports from 2018 to 2020 [0.03%]
精准医疗在监管决策中的应用：欧盟公共评估报告（2018-2020）中用于患者选择的生物标志物分析
Elisabeth Bakker,Viktoriia Starokozhko,Jet W M Kraaijvanger et al.
Elisabeth Bakker et al.
Biomarkers can guide precision medicine in clinical trials and practice. They can increase clinical trials' efficiency through selection of study populations more likely to benefit from treatment, thus increasing statistical power and reduc...
Rademikibart (CBP-201), a next-generation monoclonal antibody targeting human IL-4Rα: Two phase I randomized trials, in healthy individuals and patients with atopic dermatitis [0.03%]
一种新型抗人类IL-4Rα单克隆抗体（CBP-201，即拉德米吉巴特）：在健康人群和特应性皮炎患者中的Ⅰ期随机临床试验
Junying Wang,Jeffery White,Kenneth J Sansone et al.
Junying Wang et al.
IL-4 and IL-13 signaling via IL-4Rα plays key roles in the pathogenesis of atopic dermatitis (AD) and asthma. Rademikibart (formerly CBP-201), a next-generation human IgG4 kappa monoclonal antibody, blocks IL-4Rα-mediated signal transduct...
Impact of posaconazole and diltiazem on pharmacokinetics of encorafenib, a BRAF V600 kinase inhibitor for melanoma and colorectal cancer with BRAF mutations [0.03%]
泊沙康唑和地尔硫卓对恩考拉非布药动学的影响：一种用于黑色素瘤和带有BRAF突变的结直肠癌的BRAF V600激酶抑制剂
Erik Hahn,Renae Chavira,Lance Wollenberg et al.
Erik Hahn et al.
Encorafenib is a potent and selective ATP competitive inhibitor of BRAF V600-mutant kinase approved for patients with BRAF-mutant melanoma and colorectal cancer. Encorafenib is mainly metabolized by cytochrome P450 (CYP) 3A4 in vitro and ma...
Applying Natural Language Processing to ClinicalTrials.gov: mRNA cancer vaccine case study [0.03%]
自然语言处理在ClinicalTrials.gov中的应用——mRNA癌症疫苗案例研究
Bianca Vora,Denison Kuruvilla,Chloe Kim et al.
Bianca Vora et al.
Recently, biotechnology and pharmaceutical industries have made strides to adopt and implement Natural Language Processing (NLP) to address challenges faced when extracting and synthesizing high volumes of information found in unstructured ...
uConsent: Addressing the gap in measuring understanding of informed consent in clinical research [0.03%]
uConsent：填补临床研究中知情同意理解测量空白的方法
Richard F Ittenbach,J William Gaynor,Jenny M Dorich et al.
Richard F Ittenbach et al.
The purpose of this study was to establish the technical merit, feasibility, and generalizability of a new measure of understanding of informed consent for use with clinical research participants. A total of 109 teens/young adults at a larg...
The use of microtracers in food-effect trials: An alternative study design for toxic drugs with long half-lives exemplified by the case for alectinib [0.03%]
微痕迹物在食物影响试验中的应用：以alectinib为例的有毒药物的长半衰期替代研究设计案例
L T van der Heijden,N Steeghs,J H Beijnen et al.
L T van der Heijden et al.
The traditional design of food-effect studies has a high patient burden for toxic drugs with long half-lives (e.g., anticancer agents). Microtracers could be used to assess food-effect in patients without influencing their ongoing treatment...
Academia and industry agreement on a feasibility tool for first-time-in-human clinical trial units [0.03%]
产学研联盟制定首次人体临床试验单位可行性的评估标准
Paloma Moraga,Paula Prieto,Almari Conradie et al.
Paloma Moraga et al.
First-time-in-human (FTIH) trials are designed to generate information on the safety, tolerability, as well as the pharmacokinetic and pharmacodynamics profile of new drugs. To ensure the safety of participants, these trials need to be cond...
MIJ821 (onfasprodil) in healthy volunteers: First-in-human, randomized, placebo-controlled study (single ascending dose and repeated intravenous dose) [0.03%]
MIL821（ONFASPRODIL）在健康志愿者中的首次人体研究：单次递增剂量及重复静脉给药的随机、双盲、安慰剂对照试验
Baltazar Gomez-Mancilla,Jeffrey A Levy,Subramanian Ganesan et al.
Baltazar Gomez-Mancilla et al.
This single-center study administered MIJ821 (onfasprodil) as an intravenous infusion to healthy volunteers and included two parts: a single ascending dose study (Part 1) and a repeated intravenous dose study (Part 2). Primary objective was...
Randomized Controlled Trial
Clinical and translational science. 2023 Nov;16(11):2236-2252. DOI:10.1111/cts.13623 2023
Long-term effects of average calcineurin inhibitor trough levels (over time) on renal function in a prospectively followed cohort of 150 kidney transplant recipients [0.03%]
一项前瞻性队列研究：平均环孢素或他克莫司血药浓度（随访多年）对肾移植受者长期肾功能的影响（150例）
Gaetano Ciancio,Jeffrey J Gaynor,Giselle Guerra et al.
Gaetano Ciancio et al.
More favorable clinical outcomes with medium-term follow-up have been reported among kidney transplant recipients receiving maintenance therapy consisting of "reduced-tacrolimus (TAC) dosing," mycophenolate mofetil (MMF), and low-dose corti...
Randomized Controlled Trial
Clinical and translational science. 2023 Nov;16(11):2382-2393. DOI:10.1111/cts.13639 2023
Trends in oncology drug lags in Japan from 2001 to 2020: A cross-sectional study [0.03%]
2001至2020年日本肿瘤药物滞后趋势的横断面研究
Hideki Maeda,Asuka Hara,Momoka Ofuchi et al.
Hideki Maeda et al.
Anticancer drugs are essential in the treatment of serious diseases, but their applications are limited by drug lags. This study investigated the characteristics of anticancer drugs approved in Japan over the past 20 years and compared the ...