Control arm augmentation and hierarchical modeling in time-to-event trials: advantages and pitfalls.
1/5 보강
In clinical trials, it is often valuable to borrow information from external data sources.
APA
Alt EM, Chang X, et al. (2025). Control arm augmentation and hierarchical modeling in time-to-event trials: advantages and pitfalls.. Biostatistics (Oxford, England), 26(1). https://doi.org/10.1093/biostatistics/kxaf021
MLA
Alt EM, et al.. "Control arm augmentation and hierarchical modeling in time-to-event trials: advantages and pitfalls.." Biostatistics (Oxford, England), vol. 26, no. 1, 2025.
PMID
40795860 ↗
Abstract 한글 요약
In clinical trials, it is often valuable to borrow information from external data sources. Unfortunately, when the external data are fully or partially incompatible with the current trial data, type I error rates can be highly inflated under traditional blanket discounting schemes such as power priors, commensurate priors, and meta-analytic predictive priors. However, such inflation of the probability of a false positive can be necessary, as the alternative is to have an underpowered study. For clinical trials with time-to-event (TTE) outcomes, this problem is exacerbated since many observations are censored. In this paper, we develop the latent exchangeability prior for TTE data. We also present a novel framework to borrow information about the treatment effect between groups as well as incorporate information from external controls. Simulation results suggest that, although efficiency gains can be achieved by borrowing information among external controls, operating characteristics in general can be quite poor under a lack of exchangeability. We apply our approach to a real clinical trial in second-line metastatic colorectal cancer.
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
🏷️ 같은 키워드 · 무료전문 — 이 논문 MeSH/keyword 기반
- A Phase I Study of Hydroxychloroquine and Suba-Itraconazole in Men with Biochemical Relapse of Prostate Cancer (HITMAN-PC): Dose Escalation Results.
- Self-management of male urinary symptoms: qualitative findings from a primary care trial.
- Clinical and Liquid Biomarkers of 20-Year Prostate Cancer Risk in Men Aged 45 to 70 Years.
- Diagnostic accuracy of Ga-PSMA PET/CT versus multiparametric MRI for preoperative pelvic invasion in the patients with prostate cancer.
- Association of patient health education with the postoperative health related quality of life in low- intermediate recurrence risk differentiated thyroid cancer patients.
- Early local immune activation following intra-operative radiotherapy in human breast tissue.