Evidence map›Paper›PMID 39242460›Full record

ArticleTherapeutic innovation & regulatory science2024

Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal Assessment.

Lu Wang, Negar Golchin, Stephanie von Klot, Claudia A Salinas, Katrin Manlik, Vaishali Patadia, Mary K Miller, Julius Asubonteng, Rachel McDermott, Julie Barberio and 1 more

Abstract read
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In one paragraph

Article in Therapeutic innovation & regulatory science, 2024. 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

11 authors.

Lu WangJanssen Research and Development LLC, The Pharmaceutical Companies of Johnson & Johnson, 200 Tournament Drive, Horsham, PA, 19044, USA.
Negar GolchinBMS, New York, USA.
Stephanie von KlotBoehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
Claudia A SalinasEli Lilly & Co, Indianapolis, USA.
Katrin ManlikBayer AG, Berlin, Germany.
Vaishali PatadiaAmgen, Thousand Oaks, USA.
Mary K MillerGenentech, A Member of the Roche Group, South San Francisco, USA.
Julius AsubontengRegeneron, Tarrytown, USA.
Rachel McDermottShionogi, Osaka, Japan.
Julie BarberioSanofi, Cambridge, MA, USA.
Geoffrey GipsonJanssen Research and Development LLC, The Pharmaceutical Companies of Johnson & Johnson, 200 Tournament Drive, Horsham, PA, 19044, USA. ggipson@its.jnj.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The expanding availability of real-world data (RWD) has led to an increase in both the interest and possibilities for using this information in postmarketing safety analyses and signal management. While there is enormous potential value from the safety insights generated through RWD, the analysis preparation, execution, and communication required to reliably deliver the evidence can be time consuming. Since the safety signal assessment process is a regulated and timebound process, any supporting RWD analyses require a rapid turnaround of well-designed and informative results. To address this challenge, a TransCelerate BioPharma working group was formed and developed a framework to help teams responsible for safety signal assessment overcome the challenges of working with RWD rapidly to deliver analyses within regulatory timelines. Here, a previously performed safety assessment was evaluated within the context of the developed framework to illustrate how the framework may be adopted in practice.

Indexed as

Product Surveillance, PostmarketingAdverse Drug Reaction Reporting SystemsData AnalysisDrug-Related Side Effects and Adverse ReactionsHumansMinimal protocolPharmacovigilanceRapid data analysisReal-world data (RWD)Safety signal assessmentTranscelerate

Identifiers

PMID39242460
PMCPMC11530479

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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.