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.

Requirements

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.)

Application

Deadline for receipt of LOI proposals: September 30, 2018

Proposals must be submitted by returning the completed downloadable pdf application form as described on the front page of that form. The application form intentionally enforces limits on the format of the application and length of specific responses. It calls for the attachment of certain items (Investigator biosketches and support letters) but no other attached supplemental materials will be considered in evaluating the application. Full proposals will be solicited from selected finalists.

Review and submission of full proposals: LOI reviews will be conducted by members of the OSI Scientific Advisory and Institute Executive Boards. Finalists will be notified by November 1, 2018, and asked to submit full proposals by December 15, 2018.

The grant award will be announced immediately after final reviews are completed, estimated on January 15, 2019.

Funding will be supplied on a per patient basis after an upfront award is made to initiate the trial start.

Published by the Osteosarcoma Institute on August 1, 2018