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Special Communication
November 4, 2021

Implications of Selection Bias Due to Delayed Study Entry in Clinical Genomic Studies

Author Affiliations
  • 1Memorial Sloan Kettering Cancer Center, New York, New York
  • 2Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts
  • 3American Association for Cancer Research, Philadelphia, Pennsylvania
  • 4Vanderbilt University Medical Center, Nashville, Tennessee
  • 5Princess Margaret Cancer Centre, Toronto, Ontario, Canada
JAMA Oncol. Published online November 4, 2021. doi:10.1001/jamaoncol.2021.5153

Importance  Real-world data sets that combine clinical and genomic data may be subject to left truncation (when potential study participants are not included because they have already passed the milestone of interest at the time of study recruitment). The lapse between diagnosis and molecular testing can present analytic challenges and threaten the validity and interpretation of survival analyses.

Observations  Effects of ignoring left truncation when estimating overall survival are illustrated using data from the American Association for Cancer Research (AACR) Project Genomics Evidence Neoplasia Information Exchange Biopharma Collaborative (GENIE BPC), and a straightforward risk-set adjustment approach is described. Ignoring left truncation results in overestimation of overall survival: unadjusted median survival estimates from diagnosis among patients with stage IV non–small cell lung cancer or stage IV colorectal cancer were overestimated by more than 1 year.

Conclusions and Relevance  Clinicogenomic data are a valuable resource for evaluation of real-world cancer outcomes and should be analyzed using appropriate methods to maximize their potential. Analysts must become adept at application of appropriate statistical methods to ensure valid, meaningful, and generalizable research findings.

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