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Detecting treatment differences in group sequential longitudinal studies with covariate adjustment

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  • Neal O. Jeffries
  • James F. Troendle
  • Nancy L. Geller

Abstract

In longitudinal studies comparing two treatments over a series of common follow‐up measurements, there may be interest in determining if there is a treatment difference at any follow‐up period when there may be a non‐monotone treatment effect over time. To evaluate this question, Jeffries and Geller (2015) examined a number of clinical trial designs that allowed adaptive choice of the follow‐up time exhibiting the greatest evidence of treatment difference in a group sequential testing setting with Gaussian data. The methods are applicable when a few measurements were taken at prespecified follow‐up periods. Here, we test the intersection null hypothesis of no difference at any follow‐up time versus the alternative that there is a difference for at least one follow‐up time. Results of Jeffries and Geller (2015) are extended by considering a broader range of modeled data and the inclusion of covariates using generalized estimating equations. Testing procedures are developed to determine a set of follow‐up times that exhibit a treatment difference that accounts for multiplicity in follow‐up times and interim analyses.

Suggested Citation

  • Neal O. Jeffries & James F. Troendle & Nancy L. Geller, 2018. "Detecting treatment differences in group sequential longitudinal studies with covariate adjustment," Biometrics, The International Biometric Society, vol. 74(3), pages 1072-1081, September.
    • Handle: RePEc:bla:biomet:v:74:y:2018:i:3:p:1072-1081
    DOI: 10.1111/biom.12837
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    1. Neal Jeffries & Nancy L. Geller, 2015. "Longitudinal clinical trials with adaptive choice of follow-up time," Biometrics, The International Biometric Society, vol. 71(2), pages 469-477, June.
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    1. Neal O. Jeffries & James F. Troendle & Nancy L. Geller, 2023. "Evaluating treatment effects in group sequential multivariate longitudinal studies with covariate adjustment," Biometrics, The International Biometric Society, vol. 79(2), pages 1496-1506, June.

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