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Deadlines
 

OPERAND RFA - Advance the Use of Real World Evidence
Deadline: January 17, 2019 02:00 PM



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UCLA CTSI, an OptumLabs partner, is invited to submit one or more proposals to advance the use of real world evidence in medicine and regulatory decision making.  

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. We propose a program that will first use retrospective observational data to determine if such data can confirm previously published RCT results and, if successful, extend the use of the data for other potential applications. The methodology developed and utilized must be compelling to regulatory approvers, payers, and policy makers.  

To review the funding opportunity in greater depth and learn about proposal and submission requirements, please read the Request for Proposal document. Proposals are due by January 17, 2019. This opportunity is only available to OptumLabs partners.

To submit your proposal, please complete the attached Detailed Research Application (DRA) and send it to Emily Dayalji (emily.dayalji@optum.com) and Hayat Ahmed (HAhmed@BWH.Harvard.edu). 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. 

During the application period, you may attend one of our Q&A sessions to discuss the data, partnering/collaboration options and more. Session details are included in the attached calendar invitations. Two grant awardees will be selected.

KEY DATES
  • Request for Proposals Open
    • Formal announcement of Request for Proposal:  December 10
    • Partner respondents submit RFP questions:  December 13
    • Overview of RFP – Q&A sessions:  
      • December 14 (9am PT / 11am CT):
        Join Webex meeting; Meeting number (access code): 645 427 221; Meeting password: Swqmbq*6 
        Join by phone: 1-763-957-6300 US/Canada
      • December 20 (12pm PT / 2pm CT):
        Join Webex meeting; Meeting number (access code): 644 861 232; Meeting password: Php5ki2*
        Join by phone: 1-763-957-6300 US/Canada 
    • RFP application deadline:  January 17
  • Review and Selection
    • Committee member review and scoring:  January 17 – February 5
    • Grant notification:  February 15
For additional questions, please contact Emily Dayalji and Hayat Ahmed.


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