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Analysis of adverse events attribution and reporting in cancer clinical trials: A systematic review

Diego Enrico1, Federico Waisberg1, Jeannette Burton1

  • 1Argentine Association of Clinical Oncology (AAOC), Research department, Argentina.

Critical Reviews in Oncology/Hematology
|March 6, 2021
PubMed

Insights

Most oncology trial reports lack complete adverse event (AE) data, especially regarding drug attribution. This unreliability impacts understanding treatment safety for targeted therapies and immunotherapies.

Area of Science:

  • Oncology
  • Clinical Trials
  • Pharmacovigilance

Background:

  • Accurate reporting of adverse events (AEs) is crucial for evaluating cancer drug safety.
  • Bias in attributing AEs can affect the perceived risk-benefit profile of targeted therapies and immunotherapies.

Purpose of the Study:

  • To systematically review the quality of AE reporting in published oncology trials.
  • To analyze potential bias in the attribution process of AEs in cancer clinical trials.

Main Methods:

  • Systematic review of randomized, double-blind, placebo-controlled, phase 3 cancer trials published between 2000-2019.
  • Searched MEDLINE and PubMed databases for trials using targeted therapy or immunotherapy drugs.
  • Investigated the proportion of publications with complete AE reports and the AE attribution ratio.

Main Results:

  • Out of 60 trials (38,174 patients), 66.6% had incomplete AE attribution reports.
  • Lower impact factor journals were associated with deficient reporting of severe AEs (grade 3-4).
  • Median drug-related AE incidence was 49% under placebo; attribution ratios were 88.9% (active) and 53.9% (placebo).

Conclusions:

  • The reporting and attribution of AEs in oncology trials are less reliable than anticipated.
  • Incomplete AE data and attribution bias may hinder accurate safety assessments of cancer therapies.
  • Further improvements in AE reporting standards are necessary for clinical trial publications.
Keywords:
Adverse eventAttributionCancer treatmentClinical trialPlaceboToxicity

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