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.

Peripheral Nerve Stimulation

  • Knee Pain
  • Ankle and Foot pain
  • Shoulder Pain

Rehab

  • Outcomes utilizing BITS Balance for Dual Tasking with Physical/Occupational Therapy following stroke or brain injury
  • Role of Overground Dynamic Body Weight Support (DBWS) technology and/or FES in shortening patient length of stay and readmission rates

Surgical

  • Clinical/Case Studies
  • Bone Grafting-   including Spine, Foot & Ankle and Trauma applications
  • Foot/ankle surgery including soft tissue repair
  • Rotator cuff repair

Wound Healing

  • Graft Site Preparation and Biology

EXOGEN

  • Stress Fractures
  • Health Economic Outcomes Research (HEOR)
  • Foot and ankle
  • Wrist – excluding scaphoid

Hyaluronic acid treatment for new indications or new joints

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

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

Please use link below to
Request support for a study