Evidence map›Paper›PMID 31579517›Full record

ArticleNeuro-oncology practice2016

Clinical outcome assessments in neuro-oncology: a regulatory perspective.

Joohee Sul, Paul G Kluetz, Elektra J Papadopoulos, Patricia Keegan

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuro-oncology practice, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.7field-weighted citation impact, top 28% 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

12 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Focused ultrasound for brain metastases.Neuro-oncology advances · 2026
    Review
  3. Article
  4. Article
  5. Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017-2022.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023
    Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Whole-Brain Radiotherapy for Brain Metastases: Evolution or Revolution?Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Review
  11. Review
  12. Article
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

4 authors at 1 institution in 1 country.

Joohee SulOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (J.S., P.G.K., P.K.); Clinical Outcome Assessments Staff, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (E.J.P.).
Paul G KluetzOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (J.S., P.G.K., P.K.); Clinical Outcome Assessments Staff, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (E.J.P.).
Elektra J PapadopoulosOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (J.S., P.G.K., P.K.); Clinical Outcome Assessments Staff, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (E.J.P.).
Patricia KeeganOffice of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (J.S., P.G.K., P.K.); Clinical Outcome Assessments Staff, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland (E.J.P.).
Center for Drug Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Overall survival, progression-free survival, and to a lesser extent objective response rate, have long been the most widely accepted endpoints used to evaluate clinical benefit in oncology trials. More recently, clinical outcome assessments (COAs) that measure the impact of disease and treatment on patients' symptoms and function have been recognized as having potential to be an integral component of the risk/benefit analysis of new therapies. Although COAs have been used to evaluate cognitive and physical functioning in neurological diseases, assessing patient-centered outcomes in individuals with malignant brain tumors presents unique challenges. The approach to developing appropriate instruments to measure COAs in neuro-oncology should include identifying areas requiring new tools, reviewing existing tools that may be suitable or adapted for use in clinical trials, and engaging early with regulatory agencies to standardize a set of well-defined and reliable instruments to quantify important patient-centered outcomes.

Indexed as

clinical outcome assessmentpatient-reported outcomesregulatory guidance

Identifiers

PMID31579517
PMCPMC6760344
OpenAlexW2277185076

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.