Investigator Initiated Study Request


Pre-clinical and Clinical Investigator Initiated Study Support Request Procedure

The Investigator Initiated Studies Committee is charged with considering requests for pre-clinical and clinical study support. The committee may award funding to institutions, medical foundations, and professional societies whose mission includes public health treatment, scientific research and/or medical education.

For clinical studies the investigator is responsible for obtaining IRB approval prior to Bioventus providing the initial funds for the study. For pre-clinical studies, the investigator is responsible for following relevant national ethical guidelines. Both clinical and pre-clinical studies undergo an additional ethical review by the investigator initiated studies committee.

For new indication studies the investigator is responsible for obtaining regulatory approval through the appropriate national body. In the USA approval for investigator initiated IDE trials is provided by the FDA.

Each request must include:

  1. The name and address of the research institute
  2. Principal Investigator
  3. A study protocol containing the following information
    • Study Purpose
    • Background/Overview
    • Methods
    • Study design
    • Study variables
      • Primary variables
      • Secondary variables
      • Exploratory variables
    • Estimated Sample Size
    • Inclusion/exclusion criteria
    • Statistical Methods and assumptions (if any)
    • Criterion for study success

Surgical

  1. Study Timeline
  2. Realistic patient recruitment and follow-up time goals
  3. CVs for all study investigators
  4. The amount requested and a budget of how funds will be spent
  5. For product donations, a list of desired products  should be provided

Hyaluronic acid treatment for new indications or new joints

  • Small joints
  • Comparator HA studies (active treatment vs. placebo)
  • Health Economic Outcomes Research (HEOR)
  • Pharmacoeconomic data – AE costs
  • Duration effect and safety data
  • Safety and efficacy data of repeat dosing

Surgical

  • Clinical and case studies
  • Bone Grafting (spine and trauma bone grafting)
  • Foot and Ankle Surgery

Please use link below to
Request support for a study