Inefficiency of two-stage designs in phase II oncology clinical trials with high proportion of inevaluable patients.

ABSTRACT:

Background

Two-stage designs are commonly used for oncology Phase II clinical trials with a binary response endpoint. An issue that has not gained sufficient attention is the potential inefficiency in the usage of two-stage designs due to multiple enrollment suspensions when the proportion of patients inevaluable for response is high.

Methods

Simulation studies were used to assess the performance of Simon's two-stage designs, two-stage designs with a proposed modification, and a single-stage design in the context of Phase II clinical trials with a high proportion of patients inevaluable for response.

Results

Two-stage designs can require multiple enrollment disruptions when the inevaluable proportion is high, which can result in unacceptable inefficiency. The proposed

SUBMITTER: Ji L 

PROVIDER: S-EPMC9489679 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature