Dong Xi,Jiangtao Gou
Dong Xi
Project FrontRunner encourages development of cancer drugs for advanced or metastatic disease in an earlier clinical setting by promoting regulatory approaches such as the accelerated approval pathway. The FDA draft guideline proposes a one...
Approximate Bayesian Analysis for Borrowing External Controls for Randomized Controlled Trials With Dynamic Borrowing and Covariate Balancing Adjustment [0.03%]
随机对照试验中利用动态借用和协变量平衡调整借用外部对照的近似贝叶斯分析
Jixian Wang,Ram Tiwari
Jixian Wang
Borrowing controls from external sources has become popular for augmenting the control arm in small randomized controlled trials (RCTs). Due to the difference between the external and RCT populations, bias can be introduced that may lead to...
Trial Probability of Success for Testing 3-Way PK/PD Similarity With Multiple Endpoints [0.03%]
使用多个终点检验三者PK / PD相似性在试验中成功的概率
Rachid El Galta,Susanne Schmitt,Ramin Arani et al.
Rachid El Galta et al.
Pharmacokinetics and pharmacodynamics (PK/PD) similarity trials typically involve multiple coprimary endpoints and a 3-way treatment comparison. The purpose of these trials is to demonstrate the similarity between a biosimilar candidate and...
A Federated Data Analysis Approach for the Evaluation of Surrogate Endpoints [0.03%]
用于评估代理终点的联合数据分析方法
Dries De Witte,Ariel Alonso Abad,Diane Stephenson et al.
Dries De Witte et al.
In clinical trials, surrogate endpoints, that are more cost-effective, occur earlier, or are more frequently measured, are sometimes used to replace costly, late, or rare true endpoints. Regulatory authorities typically require thorough eva...
Estimation of the Restricted Mean Duration of Response (RMDoR) in Oncology [0.03%]
肿瘤学中对限制平均反应持续时间(RMDoR)的估计
Antonios Daletzakis,Kit C B Roes,Marianne A Jonker
Antonios Daletzakis
The duration of response (DoR) is defined as the time from the onset of response to treatment up to progression of disease or death due to any reason, whichever occurs earlier. The expected DoR could be a suitable estimand to measure the ef...
Sample Size Estimation for Correlated Count Data With Changes in Dispersion [0.03%]
相关计数数据离散变化下的样本量估计方法研究
Jintong Hou,Leslie A McClure,Savina Jaeger et al.
Jintong Hou et al.
Clinical endpoints based on repeated measurements arise in many clinical research studies, and require specialized methods for sample size and power calculations. In clinical trials that measure counts over time, such as bleeding events in ...
Dan Jackson,Di Ran,Fanni Zhang et al.
Dan Jackson et al.
Treatment switching is common in randomized trials of oncology treatments. For example, control group patients may receive the experimental treatment as a subsequent therapy. One possible estimand is the effect of trial treatment if this ty...
Estimating the Strength of Binding Affinity via Delta-Delta-G for Hit Screening After a Deming Regression Calibration [0.03%]
拆分与回归校正后的ΔΔG估算结合自由能用于 hit 扩展筛查
Kanaka Tatikola,Javier Cabrera
Kanaka Tatikola
In compound hit screening, an important chemical property is target binding affinity, represented by a parameter ΔΔG. You can measure ΔΔG experimentally (ΔΔGexp) or by calculations via simulations (ΔΔGcalc). Because it is expensive ...
Taylor Series Approximation for Accurate Generalized Confidence Intervals of Ratios of Log-Normal Standard Deviations for Meta-Analysis Using Means and Standard Deviations in Time Scale [0.03%]
基于均值和标准差的泰勒级数展开近似在广义置信区间中的应用及时间尺度上的元分析研究
Pei-Fu Chen,Franklin Dexter
Pei-Fu Chen
With contemporary anesthetic drugs, the efficacy of general anesthesia is assured. Health-economic and clinical objectives are related to reductions in the variability in dosing, variability in recovery, etc. Consequently, meta-analyses for...