{"entity":{"id":"idea-tr1-parallel-comorbidity-cohorts","kind":"idea","name":"Parallel real-world cohorts for sicker patients alongside every pivotal trial","aka":[],"tldr":"Instead of excluding sicker patients entirely, trials would run a side group for them, receiving the new drug with closer monitoring, so we learn how it behaves in the people who will actually get it.","summary":"Registrational trials open a non-randomised parallel cohort for patients who fail the main eligibility on performance status (ECOG 2), organ function, or comorbidity, treated with the experimental regimen under a pre-specified safety and dose-adjustment plan, with PK sampling. Data are analysed separately and included in the label as descriptive evidence. Precedent: NCI organ-dysfunction working group studies and some sponsor expansion cohorts.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Trials do not represent the people who get cancer): Loree et al., Disparity of race reporting and representation in trials leading to cancer drug approvals (JAMA Oncology 2019)","url":"https://doi.org/10.1001/jamaoncol.2019.1870"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["geriatric-assessment"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-trial-diversity","b-aging-comorbidity"],"keyPapers":["paper-loree-jama-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Parallel cohorts will generate dosing and safety guidance for ECOG 2 and organ-impaired patients at approval in most programmes, and real-world toxicity in those groups will fall as clinicians use it.","rationale":"ECOG 2 patients are a substantial share of real-world recipients and are almost absent from trials; clinicians extrapolate from fitter patients with predictable harm.","test":"Sponsors open parallel cohorts in ten registrational trials; measure enrolment feasibility, the fraction generating label text, and subsequent real-world outcomes in the affected groups.","maturity":"early-clinical","actor":"industry","cost":"medium","horizonYears":3},"route":"/ideas/idea-tr1-parallel-comorbidity-cohorts/","neighbours":{"technology":[{"id":"geriatric-assessment","kind":"technology","name":"Geriatric assessment","route":"/technologies/geriatric-assessment/"}],"bottleneck":[{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"},{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"}],"paper":[{"id":"paper-loree-jama-oncol","kind":"paper","name":"Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018","route":"/key-papers/paper-loree-jama-oncol/"}]}}