ScholarGate
Trợ lý

So sánh phương pháp

Xem các phương pháp đã chọn cạnh nhau; những hàng khác biệt được làm nổi bật.

Thử nghiệm lâm sàng giai đoạn III kiểu Bayes×Thiết kế thử nghiệm lâm sàng Giai đoạn III thích ứng×
Lĩnh vựcDịch tễ họcDịch tễ học
HọProcess / pipelineProcess / pipeline
Năm ra đời1990s–2000s (widespread application)1969–2019 (sequential testing roots ~1969; formal adaptive design guidance 2010–2019)
Người khởi xướngDonald A. Berry; David J. Spiegelhalter (formalization in clinical context)Methodological foundations by Armitage et al. (1969); modern adaptive framework codified by FDA and ICH guidance (2010s)
LoạiConfirmatory randomized controlled trial with Bayesian inferenceInterventional confirmatory clinical trial with pre-specified interim adaptations
Công trình gốcSpiegelhalter, D. J., Abrams, K. R., & Myles, J. P. (2004). Bayesian Approaches to Clinical Trials and Health-Care Evaluation. Wiley. ISBN: 978-0471499756International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2019). ICH E9(R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials. ICH Harmonised Guideline. link ↗
Tên gọi khácBayesian confirmatory trial, Bayesian RCT Phase III, Bayesian pivotal trial, BayesCTadaptive confirmatory trial, seamless Phase II/III adaptive trial, adaptive pivotal trial, adaptive design Phase III
Liên quan56
Tóm tắtA Bayesian Phase III clinical trial is a large-scale, confirmatory randomized controlled trial that uses Bayesian statistical inference rather than conventional frequentist hypothesis testing to evaluate whether an experimental treatment meets pre-defined efficacy and safety thresholds. By combining prior evidence with accumulating trial data, it quantifies the probability that the treatment effect exceeds a clinically meaningful threshold, enabling more transparent decision-making under uncertainty.An adaptive Phase III clinical trial is a confirmatory randomized controlled trial that incorporates pre-specified rules allowing modifications to the trial design — such as sample size re-estimation, dose selection, or population enrichment — based on accumulating interim data, while preserving the Type I error rate. It sits at the top of the evidence hierarchy and is used to obtain regulatory approval of new interventions.
ScholarGateBộ dữ liệu
  1. v1
  2. 2 Nguồn tài liệu
  3. PUBLISHED
  1. v1
  2. 2 Nguồn tài liệu
  3. PUBLISHED

Đến trang tìm kiếm Tải xuống bản trình chiếu

ScholarGateSo sánh phương pháp: Bayesian Phase III Clinical Trial · Adaptive Phase III clinical trial. Truy cập ngày 2026-06-20 từ https://scholargate.app/vi/compare