[Description of adverse events in publications of clinical trials: much room for improvement.]

Area of Science:

• Oncology
• Clinical Pharmacology
• Medical Informatics

Background:

• Comprehensive toxicity description is vital for evaluating cancer therapies.
• Current reporting standards for treatment-related adverse events are frequently suboptimal.
• Incomplete toxicity data hinders accurate assessment of drug safety and efficacy.

Purpose of the Study:

• To evaluate the completeness of toxicity reporting in cancer treatment publications.
• To identify common deficiencies in the description of adverse events.
• To propose methods for improving the accuracy and comprehensiveness of toxicity reporting.

Main Methods:

• Systematic review of cancer drugs and immunotherapies approved by the Food and Drug Administration (FDA) between 2000 and 2015.
• Analysis of publication content focusing on the description of toxicities, late toxicities, duration of adverse events, and frequency of reported toxicities.
• Assessment of reporting practices in main publications and online appendixes.

Main Results:

• 95% of publications omitted descriptions of late toxicities.
• 94% of publications failed to report the duration of adverse events.
• 75% of publications limited toxicity lists to the most frequent events, indicating significant underreporting.

Conclusions:

• There is a critical need to enhance the reporting standards for cancer treatment toxicities.
• Utilizing online appendixes can significantly improve the dissemination of comprehensive adverse event data.
• More complete toxicity reporting is necessary for accurate cancer drug evaluation and patient safety.