Evidence map›Paper›PMID 27663208›Full record

ReviewAnnals of epidemiology2016

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety.

Simone P Pinheiro, Donna R Rivera, David J Graham, Andrew N Freedman, Jacqueline M Major, Lynne Penberthy, Mark Levenson, Marie C Bradley, Hui-Lee Wong, Rita Ouellet-Hellstrom

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Annals of epidemiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

10 authors.

Simone P PinheiroOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD. Electronic address: simone.pinheiro@fda.hhs.gov.
Donna R RiveraClinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
David J GrahamOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Andrew N FreedmanClinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
Jacqueline M MajorOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Lynne PenberthyClinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
Mark LevensonOffice of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Marie C BradleyOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD; Clinical & Translational Epidemiology Branch, Epidemiology and Genomics Research, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD.
Hui-Lee WongOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
Rita Ouellet-HellstromOffice of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting.

Indexed as

Product Surveillance, PostmarketingTreatment OutcomeAntineoplastic AgentsCongresses as TopicControlled Clinical Trials as TopicDrug ApprovalFemaleHumansMaleNational Cancer Institute (U.S.)NeoplasmsUnited StatesUnited States Food and Drug AdministrationAntineoplastic AgentsCancer epidemiologyDrug safetyPharmacoepidemiology

Identifiers

PMID27663208
PMCPMC5673103

What OpenQuestion holds

Textmetadata
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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.