Evidence map›Paper›PMID 28968173›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Modernizing Clinical Trial Eligibility Criteria: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research HIV Working Group.

Thomas S Uldrick, Gwynn Ison, Michelle A Rudek, Ariela Noy, Karl Schwartz, Suanna Bruinooge, Caroline Schenkel, Barry Miller, Kieron Dunleavy, Judy Wang and 2 more

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PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 87 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
87citing papers in PubMed, 3 pooled it
6.9field-weighted citation impact, top 2% 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

87 citing papers in PubMed, 3 syntheses or guidelines pooled it, 155 citations in OpenAlex.

  1. Pooled it
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  18. Review
  19. Article
  20. Editorial: Cancer in people living with HIV/AIDS.Frontiers in cellular and infection microbiology · 2025
    Article

27 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

Thomas S UldrickThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Gwynn IsonThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Michelle A RudekThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Ariela NoyThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Karl SchwartzThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Suanna BruinoogeThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Caroline SchenkelThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Barry MillerThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Kieron DunleavyThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Judy WangThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Jerome ZeldisThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Richard F LittleThomas S. Uldrick and Richard F. Little, National Cancer Institute, Bethesda; Gwynn Ison and Barry Miller, US Food and Drug Administration, Silver Spring; Michelle A. Rudek, Johns Hopkins University, Baltimore, MD; Ariela Noy, Memorial Sloan Kettering Cancer Center and Weill Medical College, New York, NY; Karl Schwartz, Patients Against Lymphoma, Riegelsville, PA; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; Kieron Dunleavy, George Washington University, Washington, DC; Judy Wang, Florida Cancer Specialists and Research Institute, Sarasota, FL; and Jerome Zeldis, Sorrento Therapeutics, San Diego, CA.
Memorial Sloan Kettering Cancer Center · US

Funding

Consortium for Advancing Management and Prevention of Cancer in People with HIVUM1CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Joseph A. Sparano · 2015 to 2026
$253.7M
University of Southern CaliforniaU01CA121947 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ABOULAFIA, DAVID M · 2006 to 2014
$54.7M
The Johns Hopkins Translational Science Team for the ET-CTNUM1CA186691 · NCI · JOHNS HOPKINS UNIVERSITY · PI Jan Hendrik Beumer, Michael A Carducci · 2014 to 2026
$21.9M
NCI NIH HHS U01 CA121947NCI NIH HHS UM1 CA121947NCI NIH HHS UM1 CA186691
6 · The paper itself

Abstract

Purpose People with HIV are living longer as a result of effective antiretroviral therapy. Cancer has become a leading cause of morbidity and mortality in this patient population. However, studies of novel cancer therapeutics have historically excluded patients with HIV. Critical review of eligibility criteria related to HIV is required to accelerate development of and access to effective therapeutics for HIV-infected patients with cancer and make studies more generalizable to this patient population. Methods From January through April 2016, the HIV Working Group conducted a series of teleconferences; a review of 46 New Drug Applications from registration studies of unique agents studied in adults with cancer that led to the initial US Food and Drug Administration approval of that agent from 2011 to 2015; and a review of HIV-related eligibility criteria from National Cancer Institute-sponsored studies. Results were discussed and refined at a multistakeholder workshop held May 12, 2016. The HIV Working Group developed recommendations for eligibility criteria that focus on pharmacologic and immunologic considerations in this patient population and that balance patient safety, access to appropriate investigational agents, and study integrity. Results Exclusion of patients with HIV remains common in most studies of novel cancer agents. Models for HIV-related eligibility criteria in National Cancer Institute-sponsored studies are instructive. HIV infection itself should no longer be an exclusion criterion for most studies. Eligibility criteria related to HIV infection that address concurrent antiretroviral therapy and immune status should be designed in a manner that is appropriate for a given cancer. Conclusion Expanding clinical trial eligibility to be more inclusive of patients with HIV is justified in most cases and may accelerate the development of effective therapies in this area of unmet clinical need.

Indexed as

Biomedical ResearchClinical Trials as TopicEligibility DeterminationHIVHIV InfectionsHumansUnited States

Identifiers

PMID28968173
PMCPMC5793223
OpenAlexW2763963251

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.