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.
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.
Potential Funding Availability and Period of Performance:
The U.S. Government (USG) Department of Defense (DOD) anticipates funding the focus areas with Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) funds.
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
It is expected that MTEC will make up to 3 awards (a single award for each focus area) to qualified Offerors to accomplish the statement of work. It is possible that a single Offeror could receive an award for more than one Focus Area.
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.
MTEC membership is required for the submission of a proposal in response to this MTEC RPP. Offerors submitting proposals as the prime contractor must be MTEC members of good standing by May 18, 2020. To join MTEC, please visit http://mtec-sc.org/how-to-join/
A Proposers Conference via webinar will be held for interested parties to have their questions answered by the USG after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled.
URL for more information:
Please direct your inquiries and correspondence to the following contacts:
- Technical and membership questions – Dr. Lauren Palestrini, MTEC Director of Research, firstname.lastname@example.org
- Administrative questions – Ms. Kathy Zolman, MTEC Director of Program Operations, email@example.com
- MTEC Member Collaboration Database Tool – Ms. Melissa Sanchez, MTEC Executive Assistant, firstname.lastname@example.org
To view this solicitation, click here.
Filed Under: Funding Opportunities