Evidence map›Paper›PMID 37285045›Full record

ArticleThe oncologist2023

The Value of Pharmaceutical Industry-Sponsored Patient Registries in Oncology Clinical Research.

E Dawn Flick, Howard R Terebelo, Susan Fish, Amani Kitali, Vrinda Mahajan, Melissa Nifenecker, Kristen Sullivan, Paul Thaler, Sarah Ussery, David L Grinblatt

Abstract read
In one paragraph

Article in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

E Dawn FlickWorldwide Health Economics and Outcomes Research (HEOR), Bristol Myers Squibb, San Francisco, CA, USA.
Howard R TerebeloProvidence Cancer Institute, Southfield, MI, USA.
Susan FishWorldwide Health Economics and Outcomes Research (HEOR), Bristol Myers Squibb, San Francisco, CA, USA.
Amani KitaliUS Medical Affairs, Bristol Myers Squibb, Summit, NJ, USA.
Vrinda MahajanCorporate Medical Affairs, Global Scientific Communications, Bristol Myers Squibb, Summit, NJ, USA.
Melissa NifeneckerResearch and Early Development Alliances, Bristol Myers Squibb, Summit, NJ, USA.
Kristen SullivanWorldwide Health Economics and Outcomes Research (HEOR), Bristol Myers Squibb, San Francisco, CA, USA.
Paul ThalerUS Medical Affairs, Bristol Myers Squibb, Summit, NJ, USA.
Sarah UsseryUS Medical Affairs, Bristol Myers Squibb, Summit, NJ, USA.
David L GrinblattNorthShore University HealthSystem, Evanston, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In May 2019, the US Food and Drug Administration (FDA) released the Framework for FDA's Real-World Evidence (RWE) Program, a draft guidance to evaluate the potential use of real-world data in facilitating regulatory decisions. As a result, pharmaceutical companies and medical communities see patient registries, which are large, prospective, noninterventional cohort studies, as becoming increasingly important in providing evidence of treatment effectiveness and safety in clinical practice. Patient registries are designed to collect longitudinal clinical data on a broad population to address critical medical questions over time. With their large sample sizes and broad inclusion criteria, patient registries are often used to generate RWE in the general and underrepresented patient populations that are less likely to be studied in controlled clinical trials. Here, we describe the value of industry-sponsored patient registries in oncology/hematology settings to healthcare stakeholders, in drug development, and in fostering scientific collaboration.

Indexed as

Drug IndustryHumansProspective StudiesRegistriesTreatment Outcomeobservational studyoncologyprospective cohort studyreal-world evidenceregistry

Identifiers

PMID37285045
PMCPMC10400140

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.