Patient-reported side-effects (PRO-CTCAE) collected and published in every registrational trial
Doctors record only part of what patients suffer. Make it compulsory that patients report their own side-effects in every trial used to approve a drug, and that those data are published next to the doctor-graded ones.
Concordance between clinician-graded CTCAE and patient-reported symptoms is poor, with clinicians systematically under-reporting frequency and severity of fatigue, nausea, neuropathy and diarrhoea. The NCI PRO-CTCAE library provides validated items. The proposal is a regulatory requirement that registrational oncology trials collect a core PRO-CTCAE set with weekly frequency during treatment, and that results appear in the primary publication and public assessment report in a standard table.
- Toxicity and quality of life are undervalued · Trials measure how long people live, not how they live. Side-effects are under-reported and under-treated.
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Shares Basch: asking patients to report symptoms online during chemotherapy improved survival, Toxicity and quality of life are undervalued.