Student or educator? Sign up with your school email and get 6 months of Pro free.
CoChat
Sign Up
Cited by 485

The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.

Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement

Open access
Kim, Edward S., Bruinooge, Suanna S., Roberts, Samantha, Ison, Gwynn, Lin, Nancy U., Gore, Lia, Uldrick, Thomas S., Lichtman, Stuart M., Roach, Nancy, Beaver, Julia A., Sridhara, Rajeshwari, Hesketh, Paul J., Denicoff, Andrea M., Garrett-Mayer, Elizabeth, Rubin, Eric, Multani, Pratik, Prowell, Tatiana M., Schenkel, Caroline, Kozak, Marina, Allen, Jeff, Sigal, Ellen, Schilsky, Richard L.·2017·Journal of Clinical Oncology
DOI 10.1200/jco.2017.73.7916
Open this paper in CoChat — free account

Abstract

Purpose: The primary purposes of eligibility criteria are to protect the safety of trial participants and define the trial population. Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardize the generalizability of results, and limit understanding of the intervention’s benefit-risk profile. Methods: ASCO, Friends of Cancer Research, and the US Food and Drug Administration examined specific eligibility criteria (ie, brain metastases, minimum age, HIV infection, and organ dysfunction and prior and concurrent malignancies) to determine whether to modify definitions to extend trials to a broader population. Working groups developed consensus recommendations based on review of evidence, consideration of the patient population, and consultation with the research community. Results: Patients with treated or clinically stable brain metastases should be routinely included in trials and only excluded if there is compelling rationale. In initial dose-finding trials, pediatric-specific cohorts should be included based on strong scientific rationale for benefit. Later phase trials in diseases that span adult and pediatric populations should include patients older than age 12 years. HIV-infected patients who are healthy and have low risk of AIDS-related outcomes should be included absent specific rationale for exclusion. Renal function criteria should enable liberal creatinine clearance, unless the investigational agent involves renal excretion. Patients with prior or concurrent malignancies should be included, especially when the risk of the malignancy interfering with either safety or efficacy endpoints is very low. Conclusion: To maximize generalizability of results, trial enrollment criteria should strive for inclusiveness. Rationale for excluding patients should be clearly articulated and reflect expected toxicities associated with the therapy under investigation.

Overview

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1200/jco.2017.73.7916

Cites

22 of 22 references verified0 citation errors · 0 not checkable

Statistics

Verification

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Citations

Cites

Show all 22 references

Cited by

See all 485

Metadata

Authors
Kim, E. S., Bruinooge, S. S., Roberts, S., Ison, G., Lin, N. U., Gore, L., Uldrick, T. S., Lichtman, S. M., Roach, N., Beaver, J. A., Sridhara, R., Hesketh, P. J., Denicoff, A. M., Garrett-Mayer, E., Rubin, E., Multani, P., Prowell, T. M., Schenkel, C., Kozak, M., Allen, J., Sigal, E., & Schilsky, R. L.
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2017-11-20
Volume
35
Issue
33
Pages
3737-3744
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2017.73.7916
OpenAlex
W2763133656
Cited by
485
References
22
FWCI
38.18
Type
journal article
Language
en
Open access
green

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

How to cite

Cite CoChat for the checks on this page, and the paper for its own findings.

This page
CoChat. (2026). Citation check: Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. https://app.cochat.ai/papers/10.1200/jco.2017.73.7916
The paper
Kim, E. S., Bruinooge, S. S., Roberts, S., Ison, G., Lin, N. U., Gore, L., Uldrick, T. S., Lichtman, S. M., Roach, N., Beaver, J. A., Sridhara, R., Hesketh, P. J., Denicoff, A. M., Garrett-Mayer, E., Rubin, E., Multani, P., Prowell, T. M., Schenkel, C., Kozak, M., . . . Schilsky, R. L. (2017). Broadening Eligibility Criteria to Make Clinical Trials More Representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2017.73.7916

Data sources

Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.