Evidence map›Paper›PMID 36465931›Full record

ArticleFrontiers in medicine2022

Transferability of real-world data across borders for regulatory and health technology assessment decision-making.

Ashley Jaksa, Patrick J Arena, Kelvin K W Chan, Rami H Ben-Joseph, Páll Jónsson, Ulka B Campbell

Abstract read
In one paragraph

Article in Frontiers in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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

17 citing papers in PubMed.

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  13. Markov modeling for cost-effectiveness using federated health data network.Journal of the American Medical Informatics Association : JAMIA · 2024
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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

6 authors.

Ashley JaksaScientific Research and Strategy, Aetion, Inc., New York, NY, United States.
Patrick J ArenaScientific Research and Strategy, Aetion, Inc., New York, NY, United States.
Kelvin K W ChanSunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada.
Rami H Ben-JosephBig Data Real World Evidence, Jazz Pharmaceuticals, Palo Alto, CA, United States.
Páll JónssonNational Institute for Health and Care Excellence, Manchester, United Kingdom.
Ulka B CampbellScientific Research and Strategy, Aetion, Inc., New York, NY, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Recently, there has been increased consideration of real-world data (RWD) and real-world evidence (RWE) in regulatory and health technology assessment (HTA) decision-making. Due to challenges in identifying high-quality and relevant RWD sources, researchers and regulatory/HTA bodies may turn to RWD generated in locales outside of the locale of interest (referred to as "transferring RWD"). We therefore performed a review of stakeholder guidance as well as selected case studies to identify themes for researchers to consider when transferring RWD from one jurisdiction to another. Our review highlighted that there is limited consensus on defining decision-grade, transferred RWD; certain stakeholders have issued relevant guidance, but the recommendations are high-level and additional effort is needed to generate comprehensive guidance. Additionally, the case studies revealed that RWD transferability has not been a consistent concern for regulatory/HTA bodies and that more focus has been put on the evaluation of internal validity. To help develop transferability best practices (alongside internal validity best practices), we suggest that researchers address the following considerations in their justification for transferring RWD: treatment pathways, nature of the healthcare system, incidence/prevalence of indication, and patient demographics. We also recommend that RWD transferability should garner more attention as the use of imported RWD could open doors to high-quality data sources and potentially reduce methodological issues that often arise in the use of local RWD; we thus hope this review provides a foundation for further dialogue around the suitability and utility of transferred RWD in the regulatory/HTA decision-making space.

Indexed as

data relevancehealth technology assessmentsreal-world dataregulatory decision-makingtransferability

Identifiers

PMID36465931
PMCPMC9709526

What OpenQuestion holds

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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.