N of 1 trials and the individualization of drug treatments

The ultimate goal of evidence based medicine is the provision of care for the individual patient using the best evidence. The responsibility falls on the clinician to determine what is best for the individual patient, and also on the patient to use the prescribed drugs appropriately. In an attempt to prove the effectiveness of their medications patients have been known to adjust their drug treatment by increasing or decreasing doses and clinicians have also been known to perform trials of therapy in circumstances where there is insufficient evidence-based information for the treatment of an individual patient. Therefore, there is need for a standardized approach to determining treatment effect in the individual patient. The N-of-1 trial provides a means of determining individualised treatment for a patient. They are single-subject, multiple crossover trials where participants are switched periodically from active to control (standard care, placebo) or between active treatments (2 or more) or between several doses of a treatment.

This project aims to provide a detailed typology of N of 1 designs; assess the particular challenges that N of 1 trials can address, and for which conditions N of 1 trials are most useful; and determine if N of 1 trials is an effective way of determining treatment for a patient.

The first phase of the project involves a systematic review of N-of-1 trials, which will help to answer above questions. Second phase involves a survey or interviews with clinicians involved in N-of-1 trials to determine its clinical application.

For more information, please read the project proposal.