Post-traumatic Stress Disorder-Drug Treatment (PTSD-DT) Adaptive Platform Trial (APT)

This notice has been amended to extend the due date from 21 May 2020 to 28 May 2020. 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 selectionprocess 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. See the attachment for the details of this RPP. 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), $250K'Focus Area #3 (Clinical and Clinical Operations): 5 years (FY2021 - FY2025) $25.5M Acquisition Approach: Full proposals are required in response to this RPP thus reflecting a single stage acquisition approach. Full proposals are due no later than May 28, 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. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, "nontraditional" defense contractors, academic research institutions and not-for-profit organizations. For more information about the RPP, please visit the MTEC website (a link is included in the attachment incorporated into this posting).