Flexion is committed to supporting investigator-initiated research (IIR) to expand clinical and scientific knowledge related to osteoarthritis of the knee and to our first product, Zilretta (triamcinolone acetonide extended release injectable suspension 32 mg), also known as TA-ER. The IIR program is open to investigators who are interested in conducting their own independently sponsored research. Proposals may be pilot studies that are interventional or observational in nature that focus on key issues and sub-populations.
Flexion has a review process that thoroughly evaluates each IIR submission, and considers parameters such as priority alignment, scientific novelty, study design, study feasibility, investigator qualifications and study cost. Priority will be given to projects that aim to significantly contribute to clinical decision-making, support our medical strategies, and complement ongoing and planned internal research.
Our current priority areas include the following:
- TA-ER efficacy in knee OA using novel objective endpoints
- TA-ER efficacy in knee OA using Patient Reported Outcomes (PROs) not previously studied
- TA-ER efficacy in patients with knee OA and comorbid conditions or other sub-populations
- TA-ER in combination with non-pharmacologic therapies
- TA-ER use in different knee OA disease management paradigms
- TA-ER use in other musculoskeletal conditions
- TA-ER impact on health care resource utilization and/or total cost of care
- Pathophysiology of OA and/or mechanism of action of TA-ER
In general, proposals that Flexion will not support at this time include the following:
- Studies which are similar to ongoing or planned Flexion-sponsored or IIR studies
- Studies utilizing TA-ER in alternate routes of administration (e.g. intrathecal)
- Pre-clinical (in vitro or in vivo) studies using TA-ER
- Studies in non-musculoskeletal conditions
- Case studies or small case series
- Pediatric studies
Investigators interested in submitting a short concept to Flexion for consideration must fill out the required information within the web portal (e-mail submissions are not accepted). Please be advised that submission of research proposals – including those that align with our priority areas – does not imply or guarantee approval. The IIR review process at Flexion Therapeutics consists of two steps:
- Concept review by the Concept Review Committee
We aim to review and provide initial feedback on concept submissions within 45 days of the submission date. Once an IIR concept is approved by the Concept Review Committee, a detailed protocol, timelines and budget must be submitted through the IIR online portal for protocol review by the IIR Review Committee (IIRC).
- Protocol and budget review by the IIR Review Committee (IIRC)
We aim to review and provide initial feedback on protocol submissions within 45 days of the full protocol submission date. In many cases there may be additional questions or requests for clarification before a final decision is made. If the proposal is approved by the IIRC, Flexion will request regulatory documentation, including an IIR Agreement, Institutional Review Board (IRB) approval, Investigational New Drug (IND) approval by the Federal Drug Administration (FDA) if applicable, Informed Consent Form (ICF) approval by the IRB, etc. before the study is fully approved and activated.
Documents to Download
- Flexion Therapeutics IIR Protocol Template
- Flexion IIR Final Study Report Template
- IIR Guidance Document
- Financial Disclosure Form
*see full prescribing information at zilrettalabel.com
For technical assistance with the grant management system, please email Envision Technology Solutions at iEnvision_general_request@envisionpharmagroup.com.
For any questions related to the IIR grant process and/or submissions please email Flexion’s Investigator Initiated Research Department at IIR@flexiontherapeutics.com.