Evidence map›Paper›PMID 40041193›Full record

ReviewFrontiers in public health2025

The relevance of the real-world evidence in research, clinical, and regulatory decision making.

Valton Costa, Marcelo Graziano Custodio, Eran Gefen, Felipe Fregni

Abstract readReview
In one paragraph

Review in Frontiers in public health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–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

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

4 authors.

Valton CostaNeuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.
Marcelo Graziano CustodioGlobal Innovation and Development, Established Pharmaceuticals Division, Abbott Products Operations AG, Allschwil, Switzerland.
Eran GefenGlobal Innovation and Development, Established Pharmaceuticals Division, Abbott Products Operations AG, Allschwil, Switzerland.
Felipe FregniNeuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The scientific method has been established as the optimal approach for systematically gathering and interpreting data on various human phenomena, mainly through the adoption of strict experimental methods, such as controlled randomized trials, which is relevant for clinical decision-making and research, but also weights the regulatory processes for approval of drugs and other medical products. However, a key factor in strict methods is the generalizability of findings that may be limited to specific settings and patient characteristics. This limitation can be addressed by non-experimental methods aimed at investigating populations in naturalistic routine clinical settings, which may offer a more representative reflection of the usage, effectiveness, and safety of healthcare interventions. These approaches can generate the so-called real-world data and the resulting real-world evidence. In this narrative review, we present these concepts, explore the potential applications and advantages of real-world evidence for clinical, research, and regulatory decision-making, and discuss the challenges of employing it, the solutions to improve its generation, and lastly the current level of evidence required for the integration of real-world evidence into regulatory decision-making. We concluded that the advantages of using it, when utilized in a balanced manner, overcome the challenges and, therefore, can offer a time- and cost-saving solution for researchers, the healthcare industry, regulatory agencies, policymakers, and payers towards the patient benefit. The knowledge generated by this approach provides valuable additional insights into medical interventions in real patients under realistic daily scenarios.

Indexed as

Biomedical ResearchDecision MakingEvidence-Based MedicineHumansResearch Designclinical researchdecision-makingevidence-based medicinereal-world datareal-world evidenceregulatory process

Identifiers

PMID40041193
PMCPMC11878099

What OpenQuestion holds

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LicenceCC BY
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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.