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  11. The Fragility Of Phase 3 Trials Supporting Fda-approved Anticancer Medicines: A Retrospective Analysis.

The fragility of phase 3 trials supporting FDA-approved anticancer medicines: a retrospective analysis.

Joseph C Del Paggio1, Ian F Tannock2

  • 1Department of Medical Oncology, Thunder Bay Regional Health Sciences Centre and Northern Ontario School of Medicine, Thunder Bay, ON, Canada.

The Lancet. Oncology
|July 13, 2019

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View abstract on PubMed

Summary
This summary is machine-generated.

Many randomized controlled trials for FDA-approved anticancer drugs have a low fragility index, questioning the reliability of their positive results. This index helps assess the robustness of clinical trial data.

Area of Science:

  • Oncology
  • Clinical Trials
  • Biostatistics

Background:

  • The fragility index measures confidence in randomized controlled trial (RCT) results by quantifying sensitivity to data changes.
  • Assessing the fragility index of RCTs supporting anticancer drug approvals is crucial for understanding treatment efficacy.
  • The US Food and Drug Administration (FDA) approves numerous anticancer drugs based on clinical trial data.

Purpose of the Study:

  • To calculate the fragility index for RCTs supporting FDA-approved anticancer drugs.
  • To evaluate the robustness and reliability of positive trial outcomes for anticancer medications.

Main Methods:

  • Retrospective analysis of 36 phase 3 RCTs supporting FDA-approved anticancer drugs (2014-2018).
  • Included 17 two-arm, 1:1 randomized trials with significant positive time-to-event outcomes.

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  • Calculated fragility index by iteratively altering event/non-event data until statistical significance (p<0.05) was lost using Fisher's exact test.

    • Main Results:

    • 17 trials (47%) were eligible for fragility index analysis.
    • Median fragility index was 2 (IQR 0-27), with 53% of trials having an index of 2 or less.
    • For 29% of trials, the number lost to follow-up exceeded the fragility index.

    Conclusions:

    • A significant proportion of RCTs supporting FDA-approved anticancer drugs exhibit a low fragility index.
    • Low fragility indices challenge the certainty of demonstrated superiority over control treatments.
    • The fragility index offers a valuable metric for assessing the robustness of clinical trial evidence in oncology.