Statistical Properties of a Modified Accelerated Design for Phase I Cancer Clinical Trials

Abstract

In recent years, the accelerated design has been proposed as an improvement to the standard algorithm-based design (Simon et al., 1997; Storer, 1989). There may be situations under the proposed accelerated designs by Storer (1989) and Simon et al. (1997) in which the MTD may be declared with undesirable features. We propose a modified accelerated design in this article. Lin and Shih (2001) studied several key statistical properties for the standard algorithm-based A + B design based on the exact mathematical derivation. In this article, we derive similar key statistical properties for the accelerated design. Under certain design settings, the modified accelerated design requires fewer expected number of patients, and hence less time (sometimes significantly less time) to complete the study; however, it may incur a higher overall expected toxicity rate.

Keywords:

• A + B Design
• DLT
• MTD
• Standard algorithm-based design

Mathematics Subject Classification:

• Primary 62P10
• Secondary 92B15

Acknowledgments

We would like to thank the Associate Editor for comments that improved the presentation of this article.

Notes

†The line in boldface shows the results from the accelerated 1 + 3 + 3 design, and the line in italic shows the results from the standard 3 + 3 design.

†The line in boldface shows the results from the accelerated 1 + 3 + 3 design, and the line in italic shows the results from the standard 3 + 3 design.

†The line in boldface shows the results from the accelerated 1 + 3 + 3 design, and the line in italic shows the results from the standard 3 + 3 design.

†The line in boldface shows the results from the accelerated 1 + 3 + 3 design, and the line in italic shows the results from the standard 3 + 3 design.