Evidence map›Paper›PMID 40994776›Full record

ArticleHealth science reports2025

Combining Real-World and Clinical Trial Data Through Privacy-Preserving Record Linkage: Opportunities and Challenges-A Narrative Review.

Michael Batech, Ann Madsen, Nicolle Gatto, Tancy C Zhang, Deborah Ricci, Raymond Harvey, Najat Khan, Sid Jain

Abstract read
In one paragraph

Article in Health science reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

8 authors.

Michael BatechAetion Inc. New York City New York USA.ORCID https://orcid.org/0000-0001-9570-8180
Ann MadsenAetion Inc. New York City New York USA.
Nicolle GattoAetion Inc. New York City New York USA.ORCID https://orcid.org/0000-0002-9659-7811
Tancy C ZhangAetion Inc. New York City New York USA.
Deborah RicciJanssen Research & Development, LLC Titusville New Jersey USA.
Raymond HarveyJanssen Research & Development, LLC Titusville New Jersey USA.ORCID https://orcid.org/0000-0002-6795-519X
Najat KhanJanssen Research & Development, LLC Titusville New Jersey USA.
Sid JainJanssen Research & Development, LLC Titusville New Jersey USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background and Aims: Despite their widespread use, randomized clinical trials (RCTs) face challenges like differential loss to follow-up, which can impact validity. Real-world evidence (RWE) from real-world data (RWD) is increasingly used to address these limitations, but RCTs and RWE have provided complementary, disconnected observations of the patient journey. Privacy-preserving record linkage (PPRL) enables the integration of patient records across these data sources. This narrative review explores the potential use cases of PPRL to overcome the limitations of both RCTs and RWD for clinical research and regulatory decision-making. Methods: This manuscript is a narrative review and did not involve the collection or analysis of primary research data. The authors aimed for comprehensive topic coverage and a synthesis of key concepts from the current literature, rather than adhering to a formal systematic review protocol (e.g., PRISMA). Results: PPRL can generate a more comprehensive understanding of patient interaction with the healthcare system. For example, long-term information about participants before and after a trial can assist in identifying predictors of drug response or intolerance, reducing patient burden, and providing alternatives to traditional study designs. Linked data applications include expanding patient health histories and creating comprehensive patient data repositories that enable innovative trial designs. However, opportunities remain to demonstrate the provenance, quality, and completeness of RWD sources to ensure scientific rigor. Conclusion: Combining RCTs and RWD through PPRL offers significant and insufficiently explored potential for advancing drug development research, reducing operational costs, and enhancing data availability. Further consideration of PPRL use cases may drive innovative trial designs augmented with RWD, improving the ability of this collected data to support informed decision-making.

Indexed as

big datadrug developmentlinked dataobservational studypatient data privacysecondary data analysis

Identifiers

PMID40994776
PMCPMC12453958

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.