COVID-19 Response: Request for Letters of Intent for Outpatient Studies in Human Subjects
Stanford University’s Innovative Medicines Accelerator (IMA) aims to accelerate the prototyping of innovative medicines and vaccines, and to enable hypothesis-driven studies in human subjects. The purpose of this request forletters of intent (LOI) is to leverage emerging capacity and infrastructure at Stanford to address the current COVID-19pandemic. Through this solicitation, IMA seeks to support research projects aimed at testing hypotheses in human subjects that, if validated, have the potential to yield powerful new insights into COVID-19 and tools to manage the pandemic. Competitive projects will have a strong mechanistic basis. Of particular interest are projects that:
- Have made substantial progress through support from an earlier IMA RFP (May 2020);
- Seek to utilize Stanford’s outpatient COVID-19 Clinical and Translational Research Unit (CTRU), where patients can be safely tested and/or treated; or
- Seek to undertake systems vaccinology analyses of the mechanisms by which experimental COVID-19 vaccines stimulate protective immunity in humans.
Support Provided: First-time applicants are expected to receive up to $100k for a 6- to 12-month workplan. Projects may be fully or partially funded. Awarded projects will also receive access to the COVID-19 CTRU.
Deadline: Letters of Intent must be received by December 9, 2020. This is an extension to the December 4 deadline.
Eligibility: All Stanford faculty with PI eligibility, including faculty in the Clinical Educator line are welcome to apply.
Instructions: Submit a letter of intent as a PDF (Arial, 11 point font, 0.5 inch margins) containing:
- A list of investigators. Each team must include a physician and a statistician.
- Project description in the format of a Protocol Synopsis, including at a minimum the rationale and key objectives of the study as well as the endpoints, planned enrollment, and most pertinent inclusion/exclusion criteria for subjects enrolled in the study. Investigators may download a protocol synopsis template, Protocol Synopsis Template , and copy of the request for LOI, RFLOI.
Letters of Intent should be submitted directly to the ChEM-H SlideRoom portal: https://chemh.slideroom.com/#/permalink/program/58403. Applicants do not need to submit the LOI to the Research Management Group (RMG) or Office of Sponsored Research (OSR).
Selection Process & Timeline: A committee of faculty reviewers will identify the most meritorious LOIs based on the novelty and significance of the proposed clinical study. PIs whose project ideas are selected will be invited to submit full proposals (including detailed budgets). PIs will have the option of formulating these proposals independently or with the help of a staff member from the COVID CTRU. PIs submitting full proposals will be required to meet with COVID CTRU staff at least once prior to proposal submission. The meeting will ensure that the proposed studies are compatible with the COVID CTRU workflow and operations.
Selected applicants will be invited to submit full proposals by January 8. The submission deadline for full proposals will be March 15. Final decisions on full proposals will be made by April 9.
For questions about the funding opportunity, please contact the program manager:
Elizabeth Sefton, Ph.D.
Scientific Program Manager, Stanford ChEM-H firstname.lastname@example.org
For questions about IMA, please contact:
Chaitan Khosla, Ph.D.
Director, Innovative Medicines Accelerator
Professor, Departments of Chemistry and Chemical Engineering email@example.com