7 citations · 25 across the 10 of their papers we have counts for
3 papers · 1 filter
Design of phase III trials with long-term survival outcomes based on short-term binary results
Marta Bofill Roig, Yu Shen, Guadalupe Gómez Melis
Pathologic complete response (pCR) is a common primary endpoint for a phase II trial or even accelerated approval of neoadjuvant cancer therapy. If granted, a two-arm confirmatory…
A class of two-sample nonparametric statistics for binary and time-to-event outcomes
Marta Bofill Roig, Guadalupe Gómez Melis
We propose a class of two-sample statistics for testing the equality of proportions and the equality of survival functions. We build our proposal on a weighted combination of a sco…
Decision tool and Sample Size Calculator for Composite Endpoints
Marta Bofill Roig, Jordi Cortés Martínez, Guadalupe Gómez Melis
Summary points: - This article considers the combination of two binary or two time-to-event endpoints to form the primary composite endpoint for leading a trial. - It discusses the…