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Ideas
Dedicated cohorts for patients with performance status 2 in first-line trials

Dedicated cohorts for patients with performance status 2 in first-line trials

Trials usually take only patients who are up and about most of the day. Those who spend more time resting, a common group in real clinics, are excluded, so nobody knows how to treat them. A dedicated group in each trial would answer that.

Overview Key papers1 Connected7

Overview

First-line trials of new regimens include a pre-specified ECOG performance status 2 cohort, randomised where feasible, with safety-led dose modification, primary endpoints appropriate to the population (OS, time on treatment, QoL) and reporting in the label. Some lung cancer trials have run dedicated PS2 studies; the proposal generalises this.

Hypothesis

PS2 cohorts will show that benefit is preserved for some regimens and absent or harmful for others, information that changes real-world prescribing for a population that currently receives extrapolated care.

Rationale

PS2 patients are a sizeable share of real-world first-line recipients, especially in lung, pancreatic and upper gastrointestinal cancers, and receive full-dose regimens tested only in fitter patients.

Proposed test

Require PS2 cohorts in first-line registrational trials for three cancers with high PS2 prevalence and track the resulting label statements and real-world outcomes.

Maturity

early clinical

Who acts

industry

Cost to try

Medium ($1M to $50M)

Years to first evidence

3

Bottlenecks it attacks

Trials do not represent the people who get cancer · Older, Black, Hispanic, Asian, rural, poor and multimorbid patients are under-represented, so results may not apply to them.
Older and multimorbid patients are excluded and undertreated · Most people with cancer are over 65 but most trial patients are younger and fitter. We guess how to treat the majority.

Key papers

observationalJAMA Oncology 2019457 citations

Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018

One bottleneck page and 14 idea pages on OnCo cite this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing pages listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.

Connected

Similar pages

Idea
Parallel real-world cohorts for sicker patients alongside every pivotal trial
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Older and multimorbid patients are excluded and undertreated, Trials do not represent the people who get cancer.
Idea
Community health workers and trusted local organisations paid to recruit for trials
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Idea
Remove blanket exclusions for mental illness and dementia; support consent instead
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Idea
Paid community advisory boards with power to change protocol burden
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Idea
A public equity index for trial sites and sponsors, tied to funding
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Idea
Fix the neutrophil count rule that excludes many people of African ancestry
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Idea
Post-marketing safety monitoring stratified by ancestry and sex, with label updates
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.
Idea
Analyse and dose by sex: women get more toxicity from many cancer drugs at the same dose
Shares Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018, Trials do not represent the people who get cancer.

cancers

Gastric & gastro-oesophageal junction cancer Non-small-cell lung cancer Oesophageal cancer Pancreatic ductal adenocarcinoma

bottlenecks

Older and multimorbid patients are excluded and undertreated Trials do not represent the people who get cancer

key papers

Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals From 2008 to 2018

ProvenanceLast edited 2026-09-10 · Jude Gomila · Graph health · diff · file

Sources & links

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)

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Cancers

Non-small-cell lung cancer
Pancreatic ductal adenocarcinoma
Gastric & gastro-oesophageal junction cancer
Oesophageal cancer

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