Patient-Centered Outcomes Research InstituteObservational Analyses of Second-Line Pharmacological Agents in Type 2 Diabetes - Cycle 2 2020
Through this initiative, PCORI seeks to fund high-quality studies using observational designs that compare the effectiveness of newer versus older second-line pharmacological agents in type 2 diabetes mellitus (T2DM) among individuals at moderate cardiovascular risk (2-3 percent risk of events per year).
- How should I handle elements of the Research Plan Template (e.g. the Recruitment Plan for Prospective Studies) that are not applicable to my proposed study design?
- What aspects of the study should include stakeholder input?
- Should applicants involve actual patients as partners in our project or would partnership with an advocacy group, not a specifically identified patient, be sufficient?
- What stakeholders should our team engage as we plan and conduct our study?
- Is an Engagement Plan required for this PFA?
- Can additional primary outcomes beyond 3-point MACE be included in studies funded through this announcement?
- Is the study population restricted to individuals with moderate cardiovascular risk (2-3 percent risk of events per year)?
- Does data included in the analysis need to be solely from patients in the United States?
- Can the proposed analysis plan use only prospective data?
- Can the proposed analysis plan use only retrospective data?
- Can the proposed analysis plan use both retrospective data and prospective data?