Investigator-Initiated Trials

Investigator-Initiated Trials (IIT)

Trevena is guided by an innovative spirit and an unwavering commitment to patients. As part of our commitment to support the advancement of medical and scientific knowledge and improve patient's lives, in addition to Trevena’s own sponsored clinical research, we believe in supporting independent (investigator-initiated) clinical research trials, non-interventional studies and nonclinical research.  Support by Trevena may take the form of direct funding to cover actual costs of the trials, and/or research; provision of study drug; or a combination of both.

Trevena is currently accepting proposals for research studies in the following Areas of Interest.

  1. Treatment of Acute Pain requiring the use of a parenteral opioid
    1. Postoperative use
    2. Intraoperative use
    3. Medical Procedures
  2. Integration of the use of a parenteral opioid as a component of Enhanced Recovery After Surgery (ERAS) protocols
    1. In any healthcare setting (i.e., inpatient, ambulatory surgery center)
    2. For any surgical or medical procedure requiring the use of a parenteral opioid
  3. Health Outcomes Research
    1. Comparative outcomes with/without ERAS protocol integration
    2. Design of Cost-effectiveness/Cost-offset models
  4. Other clinical settings for the management of Acute Pain where the use of a parenteral opioid is appropriate

Trevena is committed to the support of study proposals that are scientifically sound, with study objectives focused on enhancing medical and scientific knowledge and improving patient care.  Study proposals may be submitted any time and are considered on a rolling basis.  Submission of a proposal does not imply or guarantee approval. Trevena's decision to approve or reject an IIT will not in any way be a reward or incentive for past, current, or future prescribing or purchase of any of the Company's products.

Trevena has a two-stage review process: 1) Concept Review and 2) Full Protocol Review. Once a Concept Proposal is submitted, the proposed research study is reviewed by the Trevena IIT Review Committee, based on scientific merit, proposed budget and alignment with Trevena’s overall areas of interest (as stated above). The IIT Review Committee will notify the applicant of the Committee’s decision by written communication.

Researchers are invited to submit their brief Concept Proposal by completing the Interactive Concept Proposal form and submitting to researchgrants@trevena.com.  For additional questions on the Trevena IIT program, please contact your local Medical Science Liaison.

If the concept receives a favorable review, the applicant will be invited to submit a full protocol within 90 days of the notification. Once the full protocol is approved, a mutually acceptable agreement that will set forth the obligations with respect to the study must be in place before the start of any IIT-related activities.