# Patient-reported side-effects (PRO-CTCAE) collected and published in every registrational trial

Source: https://onco.cc/ideas/idea-moon-pro-ctcae-in-every-pivotal-trial/  
OnCo record `idea-moon-pro-ctcae-in-every-pivotal-trial` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- NCI PRO-CTCAE: https://healthcaredelivery.cancer.gov/pro-ctcae/

## Connected records

- bottlenecks: [The field cannot pool its own studies, because it has not agreed what to measure](https://onco.cc/bottlenecks/rejuv-agenda-no-agreed-outcome-measures/), [Toxicity and quality of life are undervalued](https://onco.cc/bottlenecks/b-toxicity-qol/)
- key papers: [Basch: asking patients to report symptoms online during chemotherapy improved survival](https://onco.cc/key-papers/paper-basch-epro-survival-jama-2017/)
- ideas: [Agree what to measure, so the next systematic review can pool rather than narrate](https://onco.cc/ideas/idea-rejuv-core-outcome-set-for-late-effects/)
- roadmaps: [Supportive care and survivorship roadmap: making treatment bearable → proving it extends life → caring for tens of millions afterwards](https://onco.cc/roadmaps/survivorship-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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