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Updated: Apr 6, 2026

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
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The Imperative for a New Approach to Toxicity Analysis in Oncology Clinical Trials

Gita Thanarajasingam1, Joleen M Hubbard2, Jeff A Sloan2

  • 1Department of Medical Oncology (GT, JH, AG) and Alliance Statistics and Data Center (JAS), Mayo Clinic, Rochester, MN. thanarajasingam.gita@mayo.edu.

Journal of the National Cancer Institute
|August 2, 2015
PubMed

Insights

Current cancer trial adverse event reporting lacks time-based analysis, failing to capture longitudinal toxicity profiles of new therapies. Modernizing reporting methods to include time is essential for accurate patient safety assessment.

Area of Science:

  • Oncology
  • Clinical Trials
  • Pharmacovigilance

Background:

  • The evolution of individualized cancer medicine has introduced novel targeted therapies, often administered orally over extended durations.
  • Conventional adverse event (AE) reporting in clinical trials primarily focuses on high-grade events and lacks a temporal dimension.
  • Current methods do not adequately capture the longitudinal toxicity profiles or patient-reported outcomes associated with prolonged cancer treatments.

Purpose of the Study:

  • To highlight the limitations of current adverse event reporting systems in oncology clinical trials.
  • To advocate for the modernization of AE analysis to incorporate the dimension of time.
  • To emphasize the need for reporting systems that reflect the complexities of novel cancer therapies and their long-term toxicity.

Main Methods:

  • Review of current consensus methods for adverse event reporting in cancer clinical trials.
  • Analysis of the limitations of existing AE reporting in capturing longitudinal toxicity and patient-reported outcomes.
  • Comparison of traditional AE reporting with the needs posed by novel, continuous, and oral cancer therapies.

Main Results:

  • Current AE reporting systems, focused on worst-grade events, fail to depict toxicity evolution over time.
  • Existing methods do not incorporate patient-reported outcomes, which are crucial for therapies lasting months or years.
  • The omission of time-related information leads to an incomplete and potentially inaccurate depiction of adverse events.

Conclusions:

  • The current consensus method for AE reporting in cancer trials is insufficient for evaluating novel therapies with extended treatment durations.
  • Modernizing AE analysis to include time-related information is critical for accurately assessing drug safety and tolerability.
  • Incorporating temporal data and patient-reported outcomes will provide a more comprehensive understanding of treatment toxicity and its impact on patients' quality of life.

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