The N-of-1 trial design aims to provide a definitive answer as to whether a treatment works in a particular patient. As such, the entire process of testing a treatment is personalized to that patient—from the selection of measurable outcomes to the use of data once the trial is over. The approach therefore differs from most randomized controlled trials (RCTs), which are usually geared toward answering a particular research question. Yet despite their individualized design, N-of-1 trials can also be useful in clinical research. Data collected from multiple N-of-1 trials can be aggregated and—provided that the correct statistical tools are applied—analyzed to generate population-level data about drug response, while capturing far more information about intra- and interindividual heterogeneity than most RCT designs.

It is the epitome of individualized medicine and can be used in cannabis patients to determine the most effective combination of plant varieties and dosage forms.

Pros and cons of RCTs, registries, and n-of-1 studies.

RCTs

PROS:

• Randomization removes the effects of confounding variables

• Blinding eliminates observation bias

• Control group allows a true with/ without comparison

• Close monitoring of patients

• Ability to show causal relationships

CONS:

• Not always generalizable to population seen in clinical practice • Short follow-up period • Can’t detect rare events • Usually only ask one question • Often small N • Expensive

REGISTRIES

PROS:

• Patients match those seen in clinical practice (generalizable) • Generally larger than RCTs • Able to detect rare events • Suitable for much longer follow-up than RCTs • Possible to study multiple outcomes

CONS:

• Cannot judge efficacy without a control group • May be confounded by multiple variables and biases • Can’t establish causal relationships • Expensive (less than RCTs

N-OF-1 STUDIES

PROS:

• Can be done in any patient • Results take into account all patient variables • Crossover design allows for control period • Inexpensive

CONS:

• Not generalizable to other patients • May require multiple treatment periods to find an ideal solution

Professor Jacob Miguel Vigil is an associate professor in the Psychology Department at the University of New Mexico. He studies pain perception and human instincts primarily. Recently he has been working full time in the area of medical cannabis research.

Carl Hart, Ph.D., is Chair of the Department of Psychology at Columbia University and Dirk Ziff Professor of Psychology in the departments of psychology and psychiatry. He has published several scientific articles in neuropsychopharmocology and its impact on public policy and drug abuse treatment.

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Citizen Science: The N-of-1 trial design

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