CDC STACKS serves as an archival repository of CDC-published products including scientific findings, journal articles, guidelines, recommendations, or other public health information authored or co-authored by CDC or funded partners.
As a repository, CDC STACKS retains documents in their original published format to ensure public access to scientific information.
i
Unified exact design with early stopping rules for single arm clinical trials with multiple endpoints
-
7 2021
-
-
Source: Stat Methods Med Res. 30(7):1575-1588
[PDF-1.12 MB]
Details:
-
Alternative Title:Stat Methods Med Res
-
Personal Author:
-
Description:Adaptive designs are gaining popularity in early phase clinical trials because they enable investigators to change the course of a study in response to accumulating data. We propose a novel design to simultaneously monitor several endpoints. These include efficacy, futility, toxicity and other outcomes in early phase, single-arm studies. We construct a recursive relationship to compute the exact probabilities of stopping for any combination of endpoints without the need for simulation, given pre-specified decision rules. The proposed design is flexible in the number and timing of interim analyses. A R Shiny app with user-friendly web interface has been created to facilitate the implementation of the proposed design.
-
Subjects:
-
Keywords:
-
Source:
-
Pubmed ID:34159859
-
Pubmed Central ID:PMC8959087
-
Document Type:
-
Funding:
-
Volume:30
-
Issue:7
-
Collection(s):
-
Main Document Checksum:
-
Download URL:
-
File Type:
