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Oncology drug development increasingly relies on single‐arm clinical trials. External controls ( EC s) derived from electronic health record ( EHR ) databases may provide additional context. Patients from a  US ‐based oncology  EHR  database were aligned with patients from randomized controlled trials ( RCT s) and trial‐specific eligibility criteria were applied to the  EHR  dataset. Overall survival ( OS ) in the  EC ‐derived control arm was compared with  OS  in the  RCT  experimental arm. The primary outcome was  OS , defined as time from randomization or treatment initiation ( EHR ) to death. Cox regression models were used to obtain effect estimates using  EHR  data.  EC ‐derived hazard ratio estimates aligned closely with those from the corresponding  RCT  with one exception. Comparing log  HR s among all  RCT  and  EC  results gave a Pearson correlation coefficient of 0.86. Properly selected control arms from contemporaneous  EHR  data could be used to put single‐arm trials of  OS  in advanced non‐small cell lung cancer into context.

Using Electronic Health Records to Derive Control Arms for Early Phase Single‐Arm Lung Cancer Trials: Proof‐of‐Concept in Randomized Controlled Trials