Evidence map›Paper›PMID 39199742›Full record

ArticleBioengineering (Basel, Switzerland)2024

Real-World Data and Real-World Evidence in Healthcare in the United States and Europe Union.

Kelly H Zou, Marc L Berger

Abstract read
In one paragraph

Article in Bioengineering (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Data-Driven Insights in Healthcare.Healthcare (Basel, Switzerland) · 2025
    Article
  6. A Review of the Importance and Relevance of Real-World Data and Real-World Evidence.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
  7. Combined Immune Checkpoint Blockade and HelixorInternational journal of molecular sciences · 2025
    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

2 authors.

Kelly H ZouViatris Inc., Canonsburg, PA 15317, USA.ORCID 0000-0001-6297-8184
Marc L BergerMarc L. Berger, LLC., New York, NY 10026, USA.

Funding

This research was funded by Mylan Inc. The APC was waived by the journal, Bioengineering. Not applicable.
6 · The paper itself

Abstract

The use of real-world data (RWD) for healthcare decision-making is complicated by concerns regarding whether RWD is fit-for-purpose or is of sufficient validity to support the creation of credible RWE. An efficient mechanism for screening the quality of RWD is needed as regulatory agencies begin to use real-world evidence (RWE) to inform decisions about treatment effectiveness and safety. First, we provide an overview of RWD and RWE. Data quality frameworks (DQFs) in the US and EU were examined, including their dimensions and subdimensions. There is some convergence of the conceptual DQFs on specific assessment criteria. Second, we describe a list of screening criteria for assessing the quality of RWD sources. The curation and analysis of RWD will continue to evolve in light of developments in digital health and artificial intelligence (AI). In conclusion, this paper provides a perspective on the utilization of RWD and RWE in healthcare decision-making. It covers the types and uses of RWD, data quality frameworks (DQFs), regulatory landscapes, and the potential impact of RWE, as well as the challenges and opportunities for the greater leveraging of RWD to create credible RWE.

Indexed as

data discoverabilitydata privacydata qualitydata typesinteroperabilityreal-world datareal-world evidence

Identifiers

PMID39199742
PMCPMC11351410

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.