The patients’ clinicians are also contacted as part of the study. The intervention encourages these patients to consider oral anticoagulant treatment.
#Define collaboratory trial
The study is an 80,000-person individually randomized trial using the FDA Sentinel System to identify and conduct a direct-mail intervention to health plan members with atrial fibrillation who are at high risk for stroke. An example is IMPACT-AFib, a project funded by FDA-Catalyst. The NIH Collaboratory DRN research partners can conduct multicenter randomized trials involving direct outreach to clinicians and health plan members. This experience can be leveraged to scale across the NIH Collaboratory DRN to prospectively collect patient-generated outcomes from recruited participants to supplement data. To demonstrate its use, the Kaiser Permanente Washington DRN research partner used the FDA MyStudies App in a pilot of a descriptive study that collected exposures and health care outcomes from 64 pregnant women. This smartphone app facilitates input of real-world data directly by patients and can be linked securely to the patient’s electronic health data in support of traditional clinical trials, pragmatic trials, observational studies, and registries.
#Define collaboratory software
Patient-reported data can be collected from health plan members using, for example, the FDA MyStudies App, a public domain software application developed on behalf of the FDA. The analysis used disease risk score stratification and propensity score matching to adjust for potential confounders. Investigators also used the DRN to conduct a prospective safety surveillance study that included 7 sequential assessments comparing the myocardial infarction risk of saxagliptin with sitagliptin, pioglitazone, second-generation sulfonylureas, and long-acting insulin ( Toh et al, 2018). The study did not find a higher risk of hospitalization for heart failure among new users of saxagliptin or sitagliptin compared with other antihyperglycemic agents. The investigators conducted a population-based, retrospective, new-user cohort study to examine associations between the use of saxagliptin and sitagliptin and the risk of hospitalization for heart failure in 18 health insurance plans and health systems in the FDA’s Mini-Sentinel program. With support from the FDA, investigators from DRN research partners evaluated the safety and effectiveness of dipeptidyl peptidase-4 inhibitors compared with other oral antihyperglycemic agents ( Toh et al, 2018). Examples of Capabilities Observational Studies of Comparative Effectiveness and Safety
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