Date of this Version


Document Type

Journal Article

Publication Details

Accepted Version.

Nikles, J., Mitchell, G.K., Clavarino, A., Yelland, M.J. & Del Mar, C.B. (2010). Stakeholders' views on the routine use of n-of-1 trials to improve clinical care and to make resource allocation decisions for drug use. Australian Health Review, 34(1), 131-136.

Access the publisher's website.

2010 HERDC submission. FoR Code: 111717, 110399

© Copyright AHHA, 2010


N-of-1 trials are empirical formal tests using a within-patient randomised, double-blind, cross-over comparison of drug and placebo (or another drug), which we adapted to study individual patients’ responses as a clinical tool to guide clinical management. We administered semi-structured interviews to gauge stakeholder perspectives on the possibility of using routine n-of-1 trials for this purpose. Stakeholders included government and non-government health care sector, and patient, clinician and consumer, organisations. Stakeholders supported more widespread implementation of n-of-1 trials, in a targeted fashion, with some caveats. Barriers to their widespread implementation included constraints on doctors’ time, doctors’ acceptance, drug company acceptance, patient willingness, and cost. Strategies for overcoming barriers included conditional Pharmaceutical Benefits Scheme listing if cost-effective. There was little consensus on which model of n-of-1 trial implementation would be most effective. We discuss different approaches to addressing the several concerns raised to enable widespread introduction of n-of-1 trials into routine clinical practice as a decision tool.



This document has been peer reviewed.


To view the content in your browser, please download Adobe Reader or, alternately,
you may Download the file to your hard drive.

NOTE: The latest versions of Adobe Reader do not support viewing PDF files within Firefox on Mac OS and if you are using a modern (Intel) Mac, there is no official plugin for viewing PDF files within the browser window.