UC San Diego has been invited to submit one or more proposals to advance the use of real world evidence in medicine and regulatory decision making. This funding opportunity is for eligible researchers with expertise in pharmacoepidemiology and health services research, observational studies using claims data, and pharmacological comparative effectiveness research with medical claims and/or electronic medical record data. To review the funding opportunity in greater depth and learn about proposal and submission requirements, please read the attached Request for Proposal document.
The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, in collaboration with OptumLabs, is pleased to offer this funding opportunity to study the conditions under which it may be possible to replicate the findings of previously published randomized clinical trials (RCTs) with observational data. Such evidence would set the stage for improving confidence in estimates of treatment effectiveness for patient populations beyond those originally studied in RCTs. The program titled Observational Patient Evidence for Regulatory Approval and uNderstanding Disease (OPERAND) is designed to better inform the use of RWE from retrospective observational studies in medicine and regulatory decision-making.
The total funding award being offered is $150,000 plus a credit for an OLDW project sandbox and reimbursement for one (1) OptumLabs SAS Server license. The $150,000 award may cover direct project costs inclusive of no more than 10% indirect institutional costs (i.e., Of the $150,000 budget, $15,000 can be indirect cost whereas the remaining $135,000 must be direct costs). – Eligibility and Funding, pg. 6, RFP OPERAND
o RFP application deadline
o Committee member review and scoring
o Grant notification
January 17 – February 5
Please note that Section 2 has already been filled out. Respondents should focus on Sections 3 (Research Plan), 7 (Resourcing and Staffing), 11 (Analysis Plan), 15 (Budget), and 16 (Project Team Responsibilities). Information contained in other sections, such as translation and publication plans, may also be helpful to the review committee in differentiating among the submitted proposals. For additional questions, please contact Emily Dayalji and Hayat Ahmed.