Evidence map›Paper›PMID 33563633›Full record

ReviewClinical cancer research : an official journal of the American Association for Cancer Research2021

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group.

Allison Magnuson, Suanna S Bruinooge, Harpreet Singh, Keith D Wilner, Shadia Jalal, Stuart M Lichtman, Paul G Kluetz, Gary H Lyman, Heidi D Klepin, Mark E Fleury and 7 more

Open access · bronzeAbstract readReview
In one paragraph

Review in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
18.3field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Observational
  8. Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 13 institutions in 2 countries.

Allison MagnusonUniversity of Rochester Medical Center, Rochester, New York. allison_magnuson@urmc.rochester.edu.
Suanna S BruinoogeAmerican Society of Clinical Oncology, Alexandria, Virginia.ORCID 0000-0002-9936-2719
Harpreet SinghFDA, Silver Spring, Maryland.
Keith D WilnerPfizer Inc, New York, New York.
Shadia JalalIndiana University School of Medicine, Indianapolis, Indiana.
Stuart M LichtmanMemorial Sloan Kettering Cancer Center, New York, New York.
Paul G KluetzFDA, Silver Spring, Maryland.
Gary H LymanFred Hutchinson Cancer Research Center, Seattle, Washington.
Heidi D KlepinWake Forest Baptist Medical Center, Winston-Salem, North Carolina.ORCID 0000-0002-6262-1123
Mark E FleuryAmerican Cancer Society Cancer Action Network, Washington, D.C.
Brad HirschSignalPath, Raleigh, North Carolina.
Allen MelemedChimerix, Durham, North Carolina.ORCID 0000-0002-2553-1575
Fernanda I ArnaldezMacroGenics, Inc, Rockville, Maryland.ORCID 0000-0003-1185-2498
Upal Basu RoyLUNGevity Foundation, Chicago, Illinois.
Caroline SchenkelAmerican Society of Clinical Oncology, Alexandria, Virginia.ORCID 0000-0002-3613-8509
Shimere SherwoodAssociation for Clinical Oncology, Alexandria, Virginia.ORCID 0000-0001-5058-492X
Elizabeth Garrett-MayerAmerican Society of Clinical Oncology, Alexandria, Virginia.ORCID 0000-0003-4709-0333
American Society of Clinical Oncology · USNational Marine Sanctuary Foundation · USArgos Therapeutics (United States) · USAtrium Health Wake Forest Baptist · USBioDelivery Sciences International (United States) · USFred Hutch Cancer Center · USIndiana University – Purdue University Indianapolis · USKettering University · USLUNGevity Foundation · USMacroGenics (United States) · USPancreatic Cancer Action Network · USThe Fertilizer Institute · USUniversity of Rochester Medical Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
Mitigating Cancer-Related Cognitive Dysfunction in Older Adults with Breast CancerK76AG064394 · NIA · UNIVERSITY OF ROCHESTER · PI MAGNUSON, ALLISON MARIAN · 2019 to 2023
$1.3M
NCI NIH HHS P30 CA008748NCI NIH HHS UG1 CA189961NIA NIH HHS K76 AG064394
6 · The paper itself

Abstract

purposePerformance status (PS) is one of the most common eligibility criteria. Many trials are limited to patients with high-functioning PS, resulting in important differences between trial participants and patient populations with the disease. In addition, existing PS measures are subjective and susceptible to investigator bias. EXPERIMENTAL

designA multidisciplinary working group of the American Society of Clinical Oncology and Friends of Cancer Research evaluated how PS eligibility criteria could be more inclusive. The working group recommendations are based on a literature search, review of trials, simulation study, and multistakeholder consensus. The working group prioritized inclusiveness and access to investigational therapies, while balancing patient safety and study integrity.

resultsBroadening PS eligibility criteria may increase the number of potentially eligible patients for a given clinical trial, thus shortening accrual time. It may also result in greater participant diversity, potentially reduce trial participant and patient disparities, and enable clinicians to more readily translate trial results to patients with low-functioning PS. Potential impact on outcomes was explored through a simulation trial demonstrating that when the number of Eastern Cooperative Oncology Group PS2 participants was relatively small, the effect on the estimated HR and power was modest, even when PS2 patients did not derive a treatment benefit.

conclusionsExpanding PS eligibility criteria to be more inclusive may be justified in many cases and could result in faster accrual rates and more representative trial populations.

Indexed as

Biomedical ResearchClinical Decision-MakingClinical Trials as TopicDisease ManagementHumansMedical OncologyNeoplasmsResearch Design

Identifiers

PMID33563633
PMCPMC8102305
OpenAlexW3127995735

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.