# A mandatory over-70s cohort with geriatric assessment in every pivotal trial

Source: https://onco.cc/ideas/idea-tr1-mandatory-older-adult-cohort/  
OnCo record `idea-tr1-mandatory-older-adult-cohort` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Most people with cancer are over 65, but trials mostly enrol younger, fitter people. Requiring a group of older patients, assessed for frailty, in every big trial would show whether the drug works and is safe for those most likely to receive it.

## Summary

Registrational trials include a pre-specified cohort or stratum of patients aged 70 and over, enrolled in proportion to disease incidence, with baseline geriatric assessment (function, cognition, comorbidity, falls, nutrition) recorded, and with efficacy, toxicity and dose modification reported by frailty category. FDA's Project Silver and the older-adults guidance support inclusion; the proposal makes it a quantitative requirement.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Trials with an older-adult cohort will find clinically relevant differences in toxicity or dosing in a meaningful fraction of agents, leading to label guidance for frail patients at approval rather than years later.
- Rationale: Older patients have different pharmacokinetics, more comorbidity and different goals; post-approval real-world toxicity is often higher than trial data predicted. Geriatric-assessment-guided care reduced toxicity in randomised trials.
- Proposed test: Compare the frequency of age- or frailty-specific label statements at approval for drugs with and without a mandated cohort, and real-world discontinuation rates in older patients.
- Maturity: early-clinical
- Actor: regulator

## Sources

- FDA: Inclusion of Older Adults in Cancer Clinical Trials: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/inclusion-older-adults-cancer-clinical-trials
- FDA Oncology Center of Excellence: Project Silver (archived copy): https://web.archive.org/web/20250120094403/https://www.fda.gov/about-fda/oncology-center-excellence/project-silver

## Connected records

- technologies: [Geriatric assessment](https://onco.cc/technologies/geriatric-assessment/)
- bottlenecks: [Older and multimorbid patients are excluded and undertreated](https://onco.cc/bottlenecks/b-aging-comorbidity/), [Trials do not represent the people who get cancer](https://onco.cc/bottlenecks/b-trial-diversity/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)
- roadmaps: [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

---
JSON: https://onco.cc/api/v1/entities/idea-tr1-mandatory-older-adult-cohort.json