ArticleHealthcare (Basel, Switzerland)2020
N-of-1 Trials: Evidence-Based Clinical Care or Medical Research that Requires IRB Approval? A Practical Flowchart Based on an Ethical Framework.
Article in Healthcare (Basel, Switzerland), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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.
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.
Who cites it
17 citing papers in PubMed.
- N -of-1 Trials in Nephrology : Moving beyond Case Series.Journal of the American Society of Nephrology : JASN · 2025Article
- Blueprint for clinical N-of-1 strategies with off-label precision treatments in monogenic epilepsies.Orphanet journal of rare diseases · 2025Review
- The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials.Trials · 2024Article
- THE VALUE OF N-OF-1 DATA IN ZOOLOGICAL MEDICINE: A METHODOLOGICAL REVIEW.Journal of zoo and wildlife medicine : official publication of the American Association of Zoo Veterinarians · 2023Review
- An Individual's Lived Experiences of Taking Cannabis-Based Medicinal Products (CBMPs) to Treat Anxiety.International journal of environmental research and public health · 2023Article
- Individualized interventions for rare genetic conditions and the research-treatment spectrum: Stakeholder perspectives.Genetics in medicine : official journal of the American College of Medical Genetics · 2023Article
- N-of-1 trials: The epitome of personalized medicine?Journal of clinical and translational science · 2023Article
- Treat by Suggestion: The Potential Use of N = 1 Trials in Functional Neurological Disorders.Movement disorders clinical practice · 2022Article
- StudyU: A Platform for Designing and Conducting Innovative Digital N-of-1 Trials.Journal of medical Internet research · 2022Article
- Conduct and Implementation of Personalized Trials in Research and Practice.Harvard data science review · 2022Article
- Improving research ethics review and governance can improve human health.Journal of the Royal Society of Medicine · 2021Article
- Methylphenidate for attention-deficit/hyperactivity disorder in patients with Smith-Magenis syndrome: protocol for a series of N-of-1 trials.Orphanet journal of rare diseases · 2021Article
- Establishment of an International Collaborative Network for N-of-1 Trials and Single-Case Designs.Contemporary clinical trials communications · 2021Article
- Review
- N-of-1 Trials in Healthcare.Healthcare (Basel, Switzerland) · 2021Article
- Translating CRISPR-Cas Therapeutics: Approaches and Challenges.The CRISPR journal · 2020Review
- The importance of small samples in medical research.Journal of postgraduate medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
N-of-1 trials can provide high-class evidence on drug treatment effectiveness at the individual patient level and have been given renewed interest over the past decade due to improvements of the initial single patient design. Despite these recent developments, there is still no consensus under what circumstances N-of-1 trials should be considered as part of evidence-based clinical care and when they represent medical research with need for institutional review board (IRB) approval. This lack of consensus forms an obstacle for a more widespread implementation of N-of-1 trials. Based upon the existing literature, we as a group of researchers involved in N-of-1 trials and members of the IRB of a tertiary academic referral center, designed a practical flowchart based on an ethical framework to help make this distinction. The ethical framework together with a practical flowchart are presented in this communication.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.