Pragmatic randomized controlled trials (RCTs) are considered the gold standard for determining the effectiveness of interventions in actual clinical practice. Traditionally designed pragmatic RCTs have high internal validity, but have been criticized for having poor external validity. They often are able to recruit only a small portion of eligible patients, which reduces both power and the generalizability to actual practice, since patients who partake in trials may differ substantially from patients treated in practice. The most common reason why patients choose not to participate in clinical trials is that they are uncomfortable with being randomized to treatment or non-treatment, a practice that deviates from what would occur in actual clinical practice. The cohort multiple randomized controlled trial (cmRCT) design was developed to address this problem, as well as other shortcomings in traditional trial designs. In the cmRCT design, individuals consent to participate in a cohort for ongoing data collection and to allow their data to be used for comparison purposes to patients from the cohort who may be offered any number of trials that are conducted in the cohort framework. The objective of this presentation is to describe the cmRCT design and how it is being implemented in the CIHR-funded Scleroderma Patient-centered Intervention Network (SPIN), as well as how it could be used in other rheumatology clinical trials.
Disclosure of Interest None declared