Thank you for your interest in Flexion’s Investigator-Initiated Research (IIR) Program. Flexion Therapeutics, Inc. is committed to supporting independent research initiatives that foster the advancement of scientific and clinical information and improve patient care. Flexion maintains a stepwise process for review of IIRs. In brief, after registering below, you will be invited to submit a brief concept proposal and if accepted after a review by Flexion’s IIR Committee, will be invited to submit a full study protocol. Details regarding submission of a brief concept proposal and a full study protocol are listed below.
Brief concept proposal: A brief concept proposal must contain an adequate amount of information for the IIR Committee to determine interest in requesting a full study protocol. When submitting a brief concept proposal, the following information will be requested (if applicable):
- Principal investigator and sub-investigators
- Brief background for the study
- Primary study objectives/endpoints
- Estimated study timelines
- Estimated total study budget
- Estimated study drug or device(s)
- Preliminary grant request: funding, drug, device, or a combination thereof
- Experience as sponsor-investigator
- Letter of intent on the requesting institution’s/practice’s letterhead
- Curriculum vitae from the principal investigator dated within the last calendar year
- Completion and submission of the Flexion Financial Disclosure Form to ascertain any conflict of interest.
Full study protocol: The IIR Committee will review all brief concept proposals for scientific merit, innovation, clinical importance/potential impact on patients, and compliance with company policy and requirements. The IIR Committee will extend contingent approval to individual applicants to proceed to the second step of the process, which is the submission of a full study protocol. Details re: the process for submitting a full study protocol can be found by reviewing the IIR Protocol Guidance document and the IIR Protocol Template document.
Please note that an invitation to submit a full study protocol does not guarantee the approval of funding.
Final Study Report: Upon approval of your full study protocol, funding and subsequent completion of your IIR study, submission of a Final Study Report will be required.
Your concept proposal will be considered by Flexion’s cross-functional research committee that meets routinely to review IIR proposals. Flexion may make suggestions to improve the scientific merit of the proposal and enhance the consistency with Flexion’s support approval criteria. The principal investigator will have full and final discretion and responsibility for all aspects of the study design, implementation, data analysis, and data dissemination, including compliance with all laws and regulations applicable to research sponsors. The terms under which Flexion will provide support must be contained in a written agreement. Flexion provides no guarantees that the research committee will provide support for your proposal.