Medicine is developing towards an era where treatments can be tailored to the individual.  This can be done by genetic testing to determine the likelihood that a treatment will work.  However, there is a simpler way - single patient or N-of-1 trials.

Single Patient trials (also called N-of-1 trials) are multiple-cycle, double blind, placebo-controlled crossover trials using standardised measures of effect. The randomisation order is independently generated for each patient. At the end of the trial the order is revealed, and the patient response is compared against the presence or absence of the test treatment.

N-of-1 trials are usually used for testing the effectiveness of medicines in individual patients.

The advantage of N-of-1 trials is that the individual patient and their clinician receive direct evidence about the effect of the treatment versus the comparator on their own symptoms, therefore treatment can be individually tailored.

It is also possible to combine the results of many N-of-1 trials to determine the effect of a therapy for a population, thus allowing rapid accumulation of strong evidence on treatment effects.

Our group have successfully completed over 600 of these trials in various areas eg palliative care and paediatric medicine. Our current work includes an international collaboration with researchers at the University of Alberta, in Canada.


+61 7 3346 5025


N-of-1 trials are usually used for testing the effectiveness of medicines in individual patients.

Core research team

  • Associate Professor Jane Nikles

    Principal Research Fellow
    RECOVER Injury Research Centre
    Principal Research Fellow
    UQ Centre for Clinical Research
  • Dr Suzanne McDonald

    Dr Suzanne McDonald

    Newcastle University, UK
    Senior Research Technician
    UQ Centre for Clinical Research
  • Lisa Mackenzie

    Ms Lisa Mackenzie

    Casual Snr Research Technician
    UQ Centre for Clinical Research
    Research Assistant for the Melatonin for Insomnia in Parkinson’s Disease study
    Clinical Neuro Research Coordinator
    Queensland Brain Institute


Professor Geoff Mitchell - Professor of General Practice, Primary Care Clinical Unit

Dr Hugh Senior

Dr James McGree



    Pediatric sleep research

    Does melatonin assist children with ADHD and insomnia to sleep better?

    Children’s sleep survey – how much improvement in sleep is enough? – from parent, child and clinician perspectives

    Parkinson’s Disease sleep research

    Does melatonin assist patients with Parkinson’s Disease and insomnia to sleep better?

    Quality use of medicines

    A series of papers about the impact of using Dose Administration Aids in Australian veterans

    N-of-1 trial research

    A series of systematic reviews of different applications of N-of-1 trials focusing on adverse events, dose comparisons and other applications of N-of-1 trials

    N-of-1 trials in complementary and alternative medicine

    The n-of-1 team collaborates with top international researchers in the field and with clinicians who wish to use n-of-1 trials in their practice including sleep physicians, sleep psychologists, various clinicians and other researchers with an interest in sleep health in Australia and internationally.

    The n-of-1 research team regularly engage with support and consumer groups, giving talks and updates on research.

    They have recently been in the media discussing the melatonin for insomnia in ADHD trial currently underway. 

    For more information see our Facebook page and Twitter page.

    The melatonin for insomnia in Parkinson's Disease trial is supported by Parkinson's Australia. For more information see our Facebook page. 

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