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MTEC -- Posttraumatic Stress Disorder-Drug Treatment (PTSD-DT) Adaptive Platform Trial (APT)
The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) to support the development and maintenance of clinical trial infrastructure for the simultaneous and sequential testing of drug interventions to treat post-traumatic stress disorder (PTSD) in an adaptive platform trial (APT) design.
Scope of Work:
The DOD has identified three focus areas for funding under this RPP. To meet the intent of this RPP, each proposal MUST specifically indicate which of the three Focus Areas described below are addressed. Offerors are not limited to a single proposal submission. If proposals include teaming across focus areas, Offerors are allowed to submit a single proposal that addresses more than one Focus Area, otherwise one proposal per focus area is preferred. Projects not aligned to at least one of these Focus Areas will not be considered for funding. It is expected that MTEC will make up to 3 awards - a single award for each focus area. It is possible that a single Offeror could receive an award for more than one Focus Area.
- Focus Area #1 (Statistical Modeling): Trial design, simulation, initiation, and execution, including drafting of key documents (e.g., statistical sections of Master Protocol, Statistical Analysis Plan, Operational Plan).
- Focus Area #2 (Drug Selection): Operationalization and execution of a drug selection process for initial and continual selection of interventions to be tested in the APT.
- Focus Area #3 (Clinical and Clinical Operations): Completion of the APT design, development of clinical trial infrastructure, and execution of the APT.
*NOTE: Refer to the full RPP for details related to each focus area’s scope of work.
Full proposals are required in response to this RPP thus reflecting a single stage acquisition approach. Full proposals are due no later than May 21, 2020 at 12:00pm Eastern Time.
Offerors must be MTEC Members in good standing.
The anticipated Period of Performance (PoP) and estimated funding available for each focus area is as follows:
- Focus Area #1 (Statistical Modeling): 5 years (FY2021 – FY2025) $630K
- Focus Area #2 (Drug Selection): 6 months (FY2021), and should not exceed $250K
- Focus Area #3 (Clinical and Clinical Operations): 5 years (FY2021 – FY2025) $25.5M