Request for proposals

Clinical Trial

Purpose

The Osteosarcoma Institute (OSI) was established in November 2017 to develop a comprehensive, rational strategy that will lead to major improvement in the life expectancy of patients with relapsed and metastatic osteosarcoma. OSI is seeking Letter of Intent (LOI) proposals to conduct a Phase 2 (or Phase 1/2) study to test the activity of a novel therapeutic approach to treat recurrent osteosarcoma patients. The primary objective of such a study should be to improve EFS at 4 months, beyond historical rates known to be in the range of 12%. Funding will be based on the proposal and correlates, and may be used to support any aspect of the clinical trial including personnel, correlative studies, etc. The proposal should include a budget justification.

Summer 2018 request (Note: Closed, Award Pending)

The proposed study may be carried out in a single institution, a clinical trials consortium, or through an existing clinical trial infrastructure. OSI will not prioritize the launch of new infrastructures to conduct trials. We will consider the proposer’s prior history of accrual for relapsed osteosarcoma patients to clinical trials, with the expectation that results will be available within a 3-year time frame or less. Other desirable characteristics for proposals include:

  1. Answering an important question
  2. Strong preclinical rationale
  3. Rigorous correlative studies to be included as secondary endpoints to allow for “productive failures”
  4. Specific and expeditious timetables for protocol development, regulatory approvals, industry agreements, IRB approvals and activation, trial accrual and reporting
  5. Cost efficiency (per patient and total) – OSI funding to be in the range of $500,000-800,000.
  6. Commitment of concurrent financial support of the trial (e.g., direct institutional support, industry and/or philanthropic support, securing drug, etc.)

Published by the Osteosarcoma Institute on August 1, 2018. Updated April 2019.