The STRATUM™ method can be easily integrated with existing recruitment technology. Access to the Visual Questionnaire (ViQ®) survey can be provided through Application Program Interface (API) capabilities, allowing for the seamless administration of the survey during the normal recruitment process. The survey itself takes approximately 5 minutes to complete.
The results provide a probability for individuals likely to perform well in following the study protocols and remain treatment-compliant versus those that are likely to struggle and/or fail.
Depending on the study design, participants can either be excluded prior to randomization (as an enrichment strategy outlined by the FDA as draft guidance to industry) (FDA 2012), or can be included and receive interventions tailored to their neuropsychological profile, improving the odds they will be successful.
The process flow
FDA Guidance for Industry 2012
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products