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- Title
N-of-1 Trials: Evidence-Based Clinical Care or Medical Research that Requires IRB Approval? A Practical Flowchart Based on an Ethical Framework.
- Authors
Stunnenberg, Bas C.; Deinum, Jaap; Nijenhuis, Tom; Huysmans, Frans; van der Wilt, Gert Jan; van Engelen, Baziel G.M.; van Agt, Frans
- 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.
- Subjects
MEDICAL care research; CLINICAL trials; INSTITUTIONAL review boards; DRUG efficacy; FLOW charts
- Publication
Healthcare (2227-9032), 2020, Vol 8, Issue 1, p49
- ISSN
2227-9032
- Publication type
Article
- DOI
10.3390/healthcare8010049