相关论文: Evaluating virtual-control-augmented trials for re…
Background: Remote patient monitoring (RPM) generates vast data, yet landmark trials (Tele-HF, BEAT-HF) failed because data volume overwhelmed clinical staff. While TIM-HF2 showed 24/7 physician-led monitoring reduces mortality by 30%, this…
Evaluating autonomous vehicle stacks (AVs) in simulation typically involves replaying driving logs from real-world recorded traffic. However, agents replayed from offline data are not reactive and hard to intuitively control. Existing…
External controls (ECs) from historical trials or real-world data have gained increasing attention as a way to augment hybrid and single-arm trials, especially when balanced randomization is infeasible. While most existing work has focused…
The weighted average treatment effect (WATE) is a causal measure for the comparison of interventions in a specific target population, which may be different from the population where data are sampled from. For instance, when the goal is to…
Importance: Coronary algorithm for cardiac sub structures and prospective real-time surveillance of cardiac dose exposure. Methods: Retro and prospective study to validate AI auto-segmentation. A 3D UNet was trained on 560 thoracic CT scans…
Augmenting the control arm in clinical trials with external data can improve statistical power for demonstrating treatment effects. In many time-to-event outcome trials, participants are subject to truncation by death. Direct application of…
Estimating individualized treatment rules (ITRs) is crucial for tailoring interventions in precision medicine. Typical ITR estimation methods rely on conditional average treatment effects (CATEs) to guide treatment assignments. However,…
Covariate adjustment is desired by both practitioners and regulators of randomized clinical trials because it improves precision for estimating treatment effects. However, covariate adjustment presents a particular challenge in…
Randomized Controlled Trials (RCT)s are relied upon to assess new treatments, but suffer from limited power to guide personalized treatment decisions. On the other hand, observational (i.e., non-experimental) studies have large and diverse…
Background: Target trial emulation (TTE) that applies trial design principles to improve the analysis of non-randomized studies is increasingly being used. Applications of TTE to emulate cluster randomized trials (RCTs) have been limited.…
In this paper, we study the effects of using an algorithm-based risk assessment instrument to support the prediction of risk of criminalrecidivism. The instrument we use in our experiments is a machine learning version ofRiskEval(name…
In randomized controlled trials (RCTs), treatment is often assigned by stratified randomization. I show that among all stratified randomization schemes which treat all units with probability one half, a certain matched-pair design achieves…
Hybrid clinical trials, that borrow real-world data (RWD), are gaining interest, especially for rare diseases. They assume RWD and randomized control arm be exchangeable, but violations can bias results, inflate type I error, or reduce…
Externally controlled trials (ECTs) compare outcomes between a single-arm trial and external controls drawn from sources such as historical trials, registries, or observational studies. In survival analysis, a major challenge arises when…
Multi-regional clinical trials (MRCTs) play an increasingly crucial role in global pharmaceutical development by expediting data gathering and regulatory approval across diverse patient populations. However, differences in recruitment…
Data availability is a bottleneck during early stages of development of new capabilities for intelligent artificial agents. We investigate the use of text generation techniques to augment the training data of a popular commercial artificial…
Background: Experimental treatments pass through various stages of development. If a treatment passes through early phase experiments, the investigators may want to assess it in a late phase randomised controlled trial. An efficient way to…
When it is not feasible to conduct randomized controlled trials (RCTs), the use of external control arms based on real-world data (RWD) may be a viable option. However, challenges arising from data heterogeneity must be addressed to ensure…
A practical limitation of cluster randomized controlled trials (cRCTs) is that the number of available clusters may be small, resulting in an increased risk of baseline imbalance under simple randomization. Constrained randomization…
Randomized controlled trials (RCTs) often include subgroup analyses to assess whether treatment effects vary across pre-specified patient populations. However, these analyses frequently suffer from small sample sizes which limit the power…