| PRIMEplus-package {PRIMEplus} | R Documentation |
Study design for immunotherapy clinical trials
Description
Perform sample size, power calculation and subsequent analysis for Immuno-oncology (IO) trials composed of responders and nonresponders.
Details
This package is an extension of the Immunotherapy.Design R package but allows for response categories of more than two categories among the treatment population, such as complete responders, partial responders, as well as non-responders.
Author(s)
Zhenzhen Xu <Zhenzhen.Xu@fda.hhs.gov>, Yongsoek Park <yongpark@pitt.edu> and Bin Zhu <bin.zhu@nih.gov>
References
Xu, Z., Park, Y., Liu, K. and Zhu, B. Treating non-responders: pitfalls and implications for cancer immunotherapy trial design. Journal of Hematology & Oncology 13, 20 (2020).
Xu, Z., Zhu, B. and Park, Y. Designing immuno-oncology clinical trials composed of responders and nonresponders. Statistics in Medicine. (Under Revision).