A clinical pharmacologic perspective on the detection and assessment of adverse drug reactions [0.03%]
临床药理学视角下的药物不良反应检测与评估
C A Naranjo
C A Naranjo
The study of a new drug includes the assessment of its pharmacologic effects, benefits (efficacy), and risks (safety). Most recent drug discontinuations in the United States and the United Kingdom have been associated with problems of safet...
Effective Strategies for Maintaining Research Participation in Clinical Trials [0.03%]
临床试验中有效维持研究参与的策略
Allen Zweben,Lisa M Fucito,Stephanie S O&#x;Malley
Allen Zweben
Achieving high protocol adherence is essential for ensuring the overall success and scientific merit of clinical trials. Strategies for maximizing recruitment and treatment adherence have been previously explored in the literature. There ha...
Evaluation of Data Entry Errors and Data Changes to an Electronic Data Capture Clinical Trial Database [0.03%]
电子临床试验数据库的数据录入错误及数据修改评估
Jules T Mitchel,Yong Joong Kim,Joonhyuk Choi et al.
Jules T Mitchel et al.
Monitoring of clinical trials includes several disciplines, stakeholders, and skill sets. The aim of the present study was to identify database changes and data entry errors to an electronic data capture (EDC) clinical trial database, and t...
A Patient Focused Solution for Enrolling Clinical Trials in Rare and Selective Cancer Indications: A Landscape of Haystacks and Needles [0.03%]
以患者为中心的选择性稀有癌症指征临床试验注册解决方案：干草堆和针头式的景观分析
Eric B Lynam,Jiin Leaw,Matthew B Wiener
Eric B Lynam
Participation of adult cancer patients in US based clinical trials has remained near 3% for decades. Traditional research methodology reaches a small fraction of the target population with a fixed number of predetermined sites. Solutions ar...
Relative Efficiency of Unequal Versus Equal Cluster Sizes for the Nonparametric Weighted Sign Test Estimators in Clustered Binary Data [0.03%]
集群二元数据非参数加权符号检验估计量的不等群大小与相等群大小的相对效率比较
Chul Ahn,Fan Hu,Seung-Chun Lee
Chul Ahn
We consider analysis of clustered binary data from multiple observations for each subject in which any two observations from a subject are assumed to have a common correlation coefficient. In the weighted sign test on proportion in clustere...
Mark D Rothmann,Jenny J Zhang,Laura Lu et al.
Mark D Rothmann et al.
In many settings, testing has been proposed to assess the effect of an experimental regimen within a biomarker-positive subgroup where it is biologically plausible that benefit is stronger in such patients, and in the overall population tha...
Nonparametric Sample Size Estimation for Sensitivity and Specificity with Multiple Observations per Subject [0.03%]
无假设的敏感性和特异性非参数样本量估计（每例多次观测）
Fan Hu,William R Schucany,Chul Ahn
Fan Hu
We propose a sample size calculation approach for the estimation of sensitivity and specificity of diagnostic tests with multiple observations per subjects. Many diagnostic tests such as diagnostic imaging or periodontal tests are character...
SCORE Study Report 8: Closed Tests for All Pair-Wise Comparisons of Means [0.03%]
SCORE研究报道8：均值的所有两两比较的封闭检验
Neal Oden,Paul C Vanveldhuisen,Ingrid U Scott et al.
Neal Oden et al.
We compare five closed tests for strong control of family-wide type I error (FWE) while making all pair-wise comparisons of means in clinical trials with multiple arms such as the SCORE Study. We simulated outcomes of the SCORE Study under ...
A New Mechanism for Tracking Publicly Available Study Volunteer Demographics [0.03%]
一种新的公开招募研究志愿者并记录其人口统计学特征的机制
Rachael Zuckerman,Kenneth Getz,Kenneth Kaitin
Rachael Zuckerman
The importance of gathering and monitoring aggregate demographic data on the annual population of study volunteers in FDA-regulated clinical trials is widely acknowledged. To date, no formal mechanism exists to capture this information. The...