Estimation of historical control rate for a single arm de-escalation study - Application to the POSITIVE trial.

CONCLUSION: External control datasets should be identified before launching single-arm, de-escalation trials and methods applied during their conduct to provide context for interim monitoring and interpretation of the final analysis.
PMID: 32535486 [PubMed - as supplied by publisher]

Source: Breast - June 1, 2020 Category: Cancer & Oncology Authors: Sun Z, Niman SM, Pagani O, Partridge AH, Azim HA, Peccatori FA, Ruggeri M, Di Leo A, Colleoni M, Gelber RD, Regan MM, POSITIVE Steering Committee Tags: Breast Source Type: research