Reporting Side Effects in Cancer Clinical Trials
More attention is now being paid to what types of side effects are reported in cancer clinical trials and how data on these side effects are collected.
Researchers are also expanding the data they collect to include patient-reported outcomes.
The articles below describe studies that have explored ways to collect patient-reported outcomes, why words like “tolerable” and “manageable” may not reflect patients’ actual experiences, the need for studies to collect data on how long side effects last, and ways to streamline reporting of adverse events to the FDA to improve patient safety.
- Cancer.gov: Collection of Patient-Reported Outcomes Feasible in Cancer Clinical Trials
- The Biomedical Journal: Reporting Harms More Transparently in Trials of Cancer Drugs
- National Library of Medicine: Adverse Event Reporting in Clinical Trials: Time to Include Duration as Well as Severity
- ASCO Post: ASCO Calls for Streamlining of Adverse Events Reporting for Cancer Clinical Trials