{"entity":{"id":"idea-moon-pro-ctcae-in-every-pivotal-trial","kind":"idea","name":"Patient-reported side-effects (PRO-CTCAE) collected and published in every registrational trial","aka":[],"tldr":"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.","summary":"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.","asOf":"2026-09-08","links":[{"label":"NCI PRO-CTCAE","url":"https://healthcaredelivery.cancer.gov/pro-ctcae/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-toxicity-qol"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Mandated PRO-CTCAE reveals substantially higher symptomatic toxicity than CTCAE tables for most regimens and changes comparative judgements between regimens with similar efficacy.","rationale":"Selective reporting persists because it is allowed. Standardised collection with a publication requirement is the cheapest fix and has precedent in CONSORT-PRO.","test":"Audit the PRO-CTCAE to CTCAE discordance across the first twenty trials under the rule; survey guideline committees on whether the data changed recommendations.","maturity":"being-tested-at-scale","actor":"regulator","cost":"small","horizonYears":2},"route":"/ideas/idea-moon-pro-ctcae-in-every-pivotal-trial/","neighbours":{"bottleneck":[{"id":"rejuv-agenda-no-agreed-outcome-measures","kind":"bottleneck","name":"The field cannot pool its own studies, because it has not agreed what to measure","route":"/bottlenecks/rejuv-agenda-no-agreed-outcome-measures/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"paper":[{"id":"paper-basch-epro-survival-jama-2017","kind":"paper","name":"Basch: asking patients to report symptoms online during chemotherapy improved survival","route":"/key-papers/paper-basch-epro-survival-jama-2017/"}],"idea":[{"id":"idea-rejuv-core-outcome-set-for-late-effects","kind":"idea","name":"Agree what to measure, so the next systematic review can pool rather than narrate","route":"/ideas/idea-rejuv-core-outcome-set-for-late-effects/"}],"roadmap":[{"id":"survivorship-roadmap","kind":"roadmap","name":"Supportive care and survivorship roadmap: making treatment bearable → proving it extends life → caring for tens of millions afterwards","route":"/roadmaps/survivorship-roadmap/"},{"id":"trial-modernisation-roadmap","kind":"roadmap","name":"Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on","route":"/roadmaps/trial-modernisation-roadmap/"}]}}