Planning for subgroup analysis: A case study of treatment-marker interaction in metastatic colorectal cancer Journal Article
| Author: | Gonen, M. |
| Article Title: | Planning for subgroup analysis: A case study of treatment-marker interaction in metastatic colorectal cancer |
| Abstract: | Subgroup analysis is a common secondary objective in clinical trials. In oncology where the outcome is often binary (such as tumor response) or time-to-event (such as survival), subgroup analysis can be formulated using an interaction term in logistic or proportional hazards regression models. We focus on a case study of planning a randomized trial in metastatic colorectal cancer possibly involving a treatment-marker interaction. We present a method that can be used to compute the power of interaction tests for a given sample size or to compute the necessary sample sizes for a desired level of power for the planned subgroup analysis. The principle idea is borrowed from analysis of variance and uses appropriate contrasts after a variance-stabilizing transformation. This method is conceptually and operationally simple. It can be applied to binary- or ordinal-marker measurements, and existing sample size tables or software can be used. The accuracy of the approximation is shown to be reasonable by simulation studies. © 2003 Elsevier Inc. All rights reserved. |
| Keywords: | immunohistochemistry; survival analysis; liver neoplasms; disease marker; diagnostic accuracy; logistic models; tumor markers, biological; colonic neoplasms; colorectal carcinoma; randomized controlled trials; computer simulation; computer program; logistic regression analysis; analysis of variance; mathematical computing; sample size; case study; logistic regression; contrast; power; humans; article; proportional hazards regression; variance-stabilizing transformation |
| Journal Title: | Controlled Clinical Trials |
| Volume: | 24 |
| Issue: | 4 |
| ISSN: | 0197-2456 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2003-08-01 |
| Start Page: | 355 |
| End Page: | 363 |
| Language: | English |
| DOI: | 10.1016/s0197-2456(03)00006-0 |
| PUBMED: | 12865031 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Export Date: 12 September 2014 -- Source: Scopus |
