Adaptive Design and the Estimand Framework
Document Type
Article
Publication Date
3-13-2019
Publication Title
Annals of Biostatistics & Biometric Applications
DOI
10.33552/ABBA.2019.01.000524
ISSN
2641-6336
Abstract
Adaptive designs allow prospectively planned modifications of a study without undermining the integrity and validity of the study. The draft ICH E9 addendum recommends the estimand framework in design, conduct, analysis, and interpretation of clinical trials for assessment of effectiveness of therapies. Herein, we discuss the possible impact and scientific implications when incorporating the estimand framework to adaptively designed clinical trials. It is hoped that this will elucidate how this framework provides a language for discussing relevant questions, related to the attributes of the estimand, that may arise from study adaptations.
Recommended Citation
Okwuokenye, Macaulay, Karl E. Peace.
2019.
"Adaptive Design and the Estimand Framework."
Annals of Biostatistics & Biometric Applications, 1 (5): 1-4: Iris Publishers LLC.
doi: 10.33552/ABBA.2019.01.000524
https://digitalcommons.georgiasouthern.edu/bee-facpubs/167
Copyright
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
