Evidence map›Paper›PMID 34592195›Full record

ReviewThe Lancet. Oncology2021

Leveraging external data in the design and analysis of clinical trials in neuro-oncology.

Rifaquat Rahman, Steffen Ventz, Jon McDunn, Bill Louv, Irmarie Reyes-Rivera, Mei-Yin C Polley, Fahar Merchant, Lauren E Abrey, Joshua E Allen, Laura K Aguilar and 9 more

Open access · greenAbstract readReview
In one paragraph

Review in The Lancet. Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 1 pooled it
8.6field-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

63 citing papers in PubMed, 1 synthesis or guideline pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Interleukin-1α (IL-1α) in pancreatic ductal adenocarcinoma: implications for immunotherapy and molecular biomarkers.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  6. Accelerating discovery: Transformative clinical trial models in neuro-oncology.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026
    Review
  7. Review
  8. Article
  9. Article
  10. Focused ultrasound for brain metastases.Neuro-oncology advances · 2026
    Review
  11. Recent Advances in Targeted Therapies for Adult Gliomas.Current neurology and neuroscience reports · 2026
    Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. The evolving landscape of leptomeningeal metastases from NSCLC: an international, contemporary, multicenter cohort study.Annals of oncology : official journal of the European Society for Medical Oncology · 2026
    Article
  17. Article
  18. Article
  19. Review
  20. Article

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

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

19 authors at 12 institutions in 2 countries.

Rifaquat RahmanDepartment of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, MA, USA. Electronic address: rrahman@bwh.harvard.edu.
Steffen VentzDepartment of Data Sciences, Dana-Farber Cancer Institute, Harvard T H Chan School of Public Health, Boston, MA, USA.
Jon McDunnProject Data Sphere, Morrisville, NC, USA.
Bill LouvProject Data Sphere, Morrisville, NC, USA.
Irmarie Reyes-RiveraF Hoffmann-La Roche, Basel, Switzerland.
Mei-Yin C PolleyDepartment of Public Health Sciences, University of Chicago, Chicago, IL, USA.
Fahar MerchantMedicenna Therapeutics, Toronto, ON, Canada.
Lauren E AbreyNovartis, Basel, Switzerland.
Joshua E AllenChimerix, Durham, NC, USA.
Laura K AguilarCandel Therapeutics, Needham, MA, USA.
Estuardo Aguilar-CordovaCandel Therapeutics, Needham, MA, USA.
David AronsNational Brain Tumor Society, Newton, MA, USA.
Kirk TannerNational Brain Tumor Society, Newton, MA, USA.
Stephen BagleyDivision of Hematology and Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Mustafa KhasrawDepartment of Neurosurgery, Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, NC, USA.
Timothy CloughesyDepartment of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Patrick Y WenCenter for Neuro-Oncology, Dana-Farber Cancer Institute, Harvard T H Chan School of Public Health, Boston, MA, USA.
Brian M AlexanderDepartment of Radiation Oncology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, MA, USA; Foundation Medicine, Cambridge, MA, USA.
Lorenzo TrippaDepartment of Data Sciences, Dana-Farber Cancer Institute, Harvard T H Chan School of Public Health, Boston, MA, USA.
Dana-Farber Cancer Institute · USCelldex Therapeutics (United States) · USNational Brain Tumor Society · USChicago Department of Public Health · USChimerix (United States) · USDana-Farber Brigham Cancer Center · USDuke University Hospital · USFoundation Medicine (United States)Novartis (Switzerland) · CHRoche (Switzerland) · CHUniversity of California, Los Angeles · USUniversity of Pennsylvania · US

Funding

UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Yvonne Yu-Hsuan Chen · 2017 to 2026
$25.2M
Statistical Methods and Validation Analyses for the Integration of External Data in Clinical TrialsR01LM013352 · NLM · DANA-FARBER CANCER INST · PI TRIPPA, LORENZO · 2021 to 2024
$1.5M
NCI NIH HHS P50 CA211015NLM NIH HHS 1R01LM013352–01A1NLM NIH HHS R01 LM013352Wellcome Trust
6 · The paper itself

Abstract

Integration of external control data, with patient-level information, in clinical trials has the potential to accelerate the development of new treatments in neuro-oncology by contextualising single-arm studies and improving decision making (eg, early stopping decisions). Based on a series of presentations at the 2020 Clinical Trials Think Tank hosted by the Society of Neuro-Oncology, we provide an overview on the use of external control data representative of the standard of care in the design and analysis of clinical trials. High-quality patient-level records, rigorous methods, and validation analyses are necessary to effectively leverage external data. We review study designs, statistical methods, risks, and potential distortions in using external data from completed trials and real-world data, as well as data sources, data sharing models, ongoing work, and applications in glioblastoma.

Indexed as

Controlled Clinical Trials as TopicMedical OncologyNeurologyResearch DesignAntineoplastic AgentsBrain NeoplasmsGlioblastomaHumansInformation DisseminationTreatment OutcomeAntineoplastic Agents

Identifiers

PMID34592195
PMCPMC8893120
OpenAlexW3202623877

What Socratic 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 Socratic graph.