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Updated: Mar 1, 2026

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Machine learning to optimize precision in the analysis of randomized trials: A journey in pre-specified, yet

Laura B Balzer1, Mark J van der Laan1, Maya L Petersen1

  • 1Division of Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, CA, USA.

Clinical Trials (London, England)
|February 28, 2026
PubMed
Summary

We developed a machine learning approach for covariate adjustment to enhance clinical trial precision. This method, targeted machine learning estimation (TMLE) with adaptive pre-specification, improves efficiency in estimating treatment effects.

Keywords:
Adaptive pre-specificationTMLEcovariate adjustmentefficiencyempirical efficiency maximizationmachine learningpre-specificationprecisionrandomized trials

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