Evidence map›Paper›PMID 28968169›Full record

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

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

Lia Gore, S Percy Ivy, Frank M Balis, Eric Rubin, Katherine Thornton, Martha Donoghue, Samantha Roberts, Suanna Bruinooge, Jennifer Ersek, Nancy Goodman and 2 more

Abstract read
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 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

47 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Three-Year Follow-Up of Nivolumab-AVD Versus Brentuximab Vedotin-AVD in Adolescents With Advanced-Stage Classic Hodgkin Lymphoma on S1826.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026
    Trial
  3. Trial
  4. Article
  5. Review
  6. Pediatric and Adolescent Hodgkin Lymphoma: Paving the Way for Standards of Care and Shared Decision Making.American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting · 2024
    Review
  7. Article
  8. Adolescents and Young Adults With Cancer: CNS Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Review
  9. Article
  10. Review
  11. Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Lia GoreLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
S Percy IvyLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Frank M BalisLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Eric RubinLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Katherine ThorntonLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Martha DonoghueLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Samantha RobertsLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Suanna BruinoogeLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Jennifer ErsekLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Nancy GoodmanLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Caroline SchenkelLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.
Gregory ReamanLia Gore, Children's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO; S. Percy Ivy, National Cancer Institute, Bethesda; Martha Donoghue and Gregory Reaman, US Food and Drug Administration, Silver Spring, MD; Frank M. Balis, Children's Hospital of Philadelphia, Philadelphia, PA; Eric Rubin, Merck Research Laboratories, Kenilworth, NJ; Katherine Thornton, Dana-Farber Cancer Institute, Boston, MA; Samantha Roberts, Friends of Cancer Research and Genentech; Nancy Goodman, Kids v Cancer, Washington, DC; Suanna Bruinooge and Caroline Schenkel, ASCO, Alexandria, VA; and Jennifer Ersek, Levine Cancer Institute, Charlotte, NC.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose Children have historically been excluded from first-in-human studies of promising new cancer drugs and later phase adult clinical trials. Delays in evaluation may result in off-label use without dosing information as the only access to new drugs. A multistakeholder workshop was convened in May 2016 by ASCO and Friends of Cancer Research to identify opportunities for when it would be scientifically appropriate to expand trial eligibility to include children younger than age 18 years in first-in-human and other adult cancer clinical trials. Methods This group convened experts from academia, government, and industry to review barriers to enrolling children and adolescents in oncology clinical trials. We evaluated the historical context, published literature, regulatory considerations, and myriad risks and benefits associated with lowering the age of enrollment on oncology clinical trials. Results We conclude that many of the historical concerns about including children early in oncology clinical trials do not apply in the current scientific and clinical environment of pediatric oncology and drug development; we provide specific recommendations for how the inclusion of children in early-phase investigational cancer drug trials might be accomplished. Automatic inclusion of pediatric patients is appropriate in early-phase trials that assess dose, safety, and pharmacokinetics in a variety of tumor types and later phase trials that assess efficacy in a specific disease that spans adult and pediatric populations. Conclusion Including children in appropriately designed adult clinical oncology trials is feasible and can be done in a way that enhances their access to these agents without compromising safety or development strategies.

Indexed as

Clinical Trials as TopicAge FactorsBiomedical ResearchHumansMedical OncologyUnited States

Identifiers

PMID28968169
PMCPMC5692725

What OpenQuestion holds

Textmetadata
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.