Evidence map›Paper›PMID 41355573›Full record

ReviewBritish journal of clinical pharmacology2026

N-of-1 trials in clinical research: Methodological foundations, statistical approaches and implementation challenges.

Marcos Clint Leal De Carvalho, Matheus de Matos Dourado Simões, Ubiratan Cardinalli Adler, Antonio Brazil Viana Junior, Caren Nádia Soares de Sousa, Lia Lira Olivier Sanders

Abstract readReview
In one paragraph

Review in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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.

Marcos Clint Leal De CarvalhoPostgraduate Program in Translational Medicine, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil.
Matheus de Matos Dourado SimõesWalter Cantídio University Hospital, Medical Residency Program, Federal University of Ceará, Fortaleza, CE, Brazil.
Ubiratan Cardinalli AdlerDepartment of Medicine, Federal University of São Carlos, São Carlos, SP, Brazil.
Antonio Brazil Viana JuniorResearch Management Unit - Brazilian Hospital Services Company (EBSERH), Fortaleza, CE, Brazil.
Caren Nádia Soares de SousaNeuropsychopharmacology Laboratory, Drug Research and Development Center, Department of Physiology and Pharmacology, School of Medicine, Federal University of Ceará, Fortaleza, CE, Brazil.
Lia Lira Olivier SandersSchool of Medicine, Department of Clinical Medicine, Federal University of Ceará, Fortaleza, CE, Brazil.

Funding

Department of Science and Technology of the Secretariat of Science, Technology, Innovation and Health, Ministry of Health of Brazil (MoH)National Council for Scientific and Technological Development (CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico)
6 · The paper itself

Abstract

N-of-1 trials offer a unique and rigorous methodology for evaluating individualized treatment responses, particularly within the context of personalized medicine. This article provides a comprehensive explanation of the conceptual and methodological underpinnings of N-of-1 trials, with particular emphasis on statistical techniques and considerations critical for their design and analysis. Existing guidelines for planning and conducting these studies are summarized, along with a discussion of the practical and theoretical challenges to their implementation in clinical practice. We provide an overview for clinicians and researchers who may be unfamiliar with the design. As most of the existing guidance has focused on design and implementation considerations, we expand on the statistical analysis. We aim to support researchers and methodologists in understanding and advancing the methodological toolkit necessary for high-quality N-of-1 research.

Indexed as

Biomedical ResearchClinical Trials as TopicPrecision MedicineResearch DesignData Interpretation, StatisticalHumansdata analysisN‐of‐1personalized medicine

Identifiers

PMID41355573
PMCPMC12930012

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.