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The effects of releasing early results from ongoing clinical trials

Author

Listed:
  • Steffen Ventz

    (Harvard T.H. Chan School of Public Health)

  • Sergio Bacallado

    (University of Cambridge)

  • Rifaquat Rahman

    (Harvard Medical School)

  • Sara Tolaney

    (Harvard Medical School)

  • Jonathan D. Schoenfeld

    (Harvard Medical School)

  • Brian M. Alexander

    (Harvard Medical School)

  • Lorenzo Trippa

    (Harvard T.H. Chan School of Public Health)

Abstract

Most trials do not release interim summaries on efficacy and toxicity of the experimental treatments being tested, with this information only released to the public after the trial has ended. While early release of clinical trial data to physicians and patients can inform enrollment decision making, it may also affect key operating characteristics of the trial, statistical validity and trial duration. We investigate the public release of early efficacy and toxicity results, during ongoing clinical studies, to better inform patients about their enrollment options. We use simulation models of phase II glioblastoma (GBM) clinical trials in which early efficacy and toxicity estimates are periodically released accordingly to a pre-specified protocol. Patients can use the reported interim efficacy and toxicity information, with the support of physicians, to decide which trial to enroll in. We describe potential effects on various operating characteristics, including the study duration, selection bias and power.

Suggested Citation

  • Steffen Ventz & Sergio Bacallado & Rifaquat Rahman & Sara Tolaney & Jonathan D. Schoenfeld & Brian M. Alexander & Lorenzo Trippa, 2021. "The effects of releasing early results from ongoing clinical trials," Nature Communications, Nature, vol. 12(1), pages 1-7, December.
    • Handle: RePEc:nat:natcom:v:12:y:2021:i:1:d:10.1038_s41467-021-21116-4
    DOI: 10.1038/s41467-021-21116-4
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