Evidence map›Paper›PMID 41123573›Full record

ReviewCancer2025

Assessing tolerability of cancer therapeutics: A regulatory perspective from the FDA Oncology Center of Excellence.

Vishal Bhatnagar, Laura Lee Johnson, Mallorie H Fiero, Flora Mulkey, Paul Kluetz

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Article
  2. Review
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

5 authors.

Vishal BhatnagarOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.ORCID https://orcid.org/0000-0003-4650-0513
Laura Lee JohnsonOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Mallorie H FieroOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Flora MulkeyOffice of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.
Paul KluetzOncology Center of Excellence, US Food and Drug Administration, Silver Spring, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patient-reported symptoms and functioning are valuable to understanding the tolerability of cancer treatments in clinical trials. Assessment of key side effects, physical and role functioning, and overall side effect bother in trials may be helpful for benefit-risk evaluation and useful to communicate in product labeling. Inclusion of these assessments has been supported in the literature and Food and Drug Administration guidance documents. In this article, the authors provide their perspective on the evolution of how this data has been considered in oncologic therapeutic evaluation and provide context for the research being presented by the National Cancer Institute Tolerability Consortium.

Indexed as

Antineoplastic AgentsNeoplasmsClinical Trials as TopicHumansPatient Reported Outcome MeasuresRisk AssessmentUnited StatesUnited States Food and Drug AdministrationAntineoplastic Agentscancer treatmentclinical outcome assessmentspatient‐reported outcomesside effectstolerability

Identifiers

PMID41123573
PMCPMC12542928

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.