Not Verified

Clinical Trials Grant Program

Osteosarcoma Institute

The primary objective of proposed Phase I/II or Phase II clinical trials in relapsed/refractory OS should be to improve event free survival (EFS) beyond known historical rates. The proposed trial may be carried out in a single institution, a clinical trial consortium, or through an existing clinical trial infrastructure. OSI will not prioritize the launch of new infrastructures to conduct clinical trials. Specific timetables for protocol development, regulatory approvals, industry agreements, IRB approvals, activation, accrual, and reporting are required. We will consider the applicant’s history of efficiently entering agreements, opening trials, and meeting accrual expectations for trials of relapsed OS patients. Our expectation is that results will be available within three years of trial initiation. Other desirable characteristics for proposals include:

• Answering an important question

• Strong preclinical rationale

• Rigorous trial design and correlative endpoints to allow for productive failure

• Budget reasonableness (per patient and total)

• Leverage from concurrent financial support of the trial (e.g., direct institutional support, industry and/or philanthropic support, securing drug, etc.)

BUDGET Up to $800,000 total over two to three years (inclusive of indirect costs not to exceed 10% of the total direct costs).

AI Based Application Success Predictor

1. Direct osteosarcoma relevance ⭐⭐⭐⭐⭐

This is the single strongest predictor.

High-fit projects should directly investigate:

Osteosarcoma biology
Osteosarcoma treatment
Metastatic osteosarcoma
Recurrent osteosarcoma
Chemotherapy resistance
Immunotherapy
Targeted therapy
Tumor microenvironment
Osteosarcoma genomics
Biomarkers
New therapeutic approaches
Pediatric/young-adult osteosarcoma
Surgical management
Metastatic disease, particularly pulmonary metastases

A general bone-cancer project without a clear osteosarcoma component would have substantially weaker fit.

2. Potential to improve survival or cure ⭐⭐⭐⭐⭐

Because osteosarcoma is aggressive and treatment options for advanced disease remain limited, the strongest projects should clearly address a clinically meaningful outcome.

Particularly compelling goals include:

Increased overall survival
Improved event-free survival
Prevention of metastasis
Treatment of metastatic disease
Prevention of recurrence
Improved response to chemotherapy
Development of disease-modifying therapies

The proposal should clearly answer:

If successful, how could this research help patients with osteosarcoma live longer or achieve better disease control?

3. Translational/clinical potential ⭐⭐⭐⭐⭐

OSI is particularly suited to research that can move efficiently from laboratory discovery toward clinical application.

A strong pathway is:

Osteosarcoma mechanism → therapeutic target → preclinical validation → clinical development

or:

Biomarker → patient stratification → treatment selection → improved response

Projects that have a credible path toward clinical testing are especially attractive.

4. Scientific significance ⭐⭐⭐⭐⭐

The proposal should address an important unanswered question.

Examples:

Why does osteosarcoma metastasize?
Why does it develop chemotherapy resistance?
Which patients are likely to relapse?
What drives pulmonary metastasis?
Which molecular pathways can be therapeutically targeted?
Why do some tumors respond while others do not?

The central hypothesis should be specific and testable.

5. Innovation ⭐⭐⭐⭐⭐

Strong areas include:

Molecular biology

Genomic alterations
Epigenetics
RNA biology
Tumor signaling pathways

Immuno-oncology

Tumor immune microenvironment
Immune evasion
Novel immunotherapies
Combination immunotherapy

Precision medicine

Molecular classification
Predictive biomarkers
Patient stratification

Therapeutics

Targeted therapies
Novel drug combinations
Drug repurposing
Novel delivery systems

Metastasis

Mechanisms of pulmonary metastasis
Metastatic niche
Circulating tumor cells

Innovation should directly address an osteosarcoma-specific barrier.

6. Treatment resistance and metastasis ⭐⭐⭐⭐⭐

These are particularly high-value research problems.

A strong proposal could investigate:

Chemotherapy resistance → molecular mechanism → therapeutic target → sensitization strategy

or:

Primary osteosarcoma → metastatic mechanism → metastasis-prevention strategy → improved survival

Research targeting metastatic or relapsed osteosarcoma can be especially compelling because of the major clinical need.

7. Methodological rigor ⭐⭐⭐⭐⭐

A competitive proposal should provide:

Strong preliminary evidence
Appropriate experimental models
Relevant osteosarcoma cell lines/models
Patient-derived material where appropriate
Appropriate controls
Adequate statistical analysis
Reproducible methodology
Clearly defined endpoints

For preclinical therapeutic studies, investigators should demonstrate that the proposed model is sufficiently representative of human osteosarcoma.

8. Feasibility ⭐⭐⭐⭐⭐

The research team should demonstrate access to:

Osteosarcoma patients
Tumor specimens
Biobanks
Pediatric/young-adult oncology populations
Molecular profiling
Animal models where required
Clinical trial infrastructure
Specialized oncology expertise
Biostatistics/bioinformatics

For a rare cancer such as osteosarcoma, access to adequate patient numbers and high-quality specimens is particularly important.

9. Investigator expertise and collaboration ⭐⭐⭐⭐☆

Because osteosarcoma is rare and multidisciplinary, strong collaborations can be a major advantage.

Useful expertise includes:

Pediatric oncology
Medical oncology
Orthopedic oncology
Surgical oncology
Pathology
Molecular biology
Immunology
Bioinformatics
Drug development
Clinical trials

A multidisciplinary team can strengthen feasibility and translational potential.

10. Accelerated clinical translation ⭐⭐⭐⭐⭐

A highly competitive proposal should explain how the research could move toward patients.

For example:

Discovery → validation → therapeutic development → regulatory/clinical pathway → clinical trial

A project that produces a clinically usable biomarker or therapeutic candidate may have greater translational value than one with no foreseeable clinical application.

Specialties

Clinical Trials

Eligibility Requirements

• Funds must be granted to nonprofit/charitable institutions or organizations. While we allow for any individual institution to submit multiple LOI submissions, we are unlikely to fund more than one grant per institution in any grant cycle.

• Grantee organization does not need to be based in the United States.

o However, to fund a foreign entity, OSI requires documentation that if the entity were a United States-based organization, the entity would qualify as a charitable organization. This is usually straightforward when dealing with entities in countries with a tax regime similar to the U.S. by way of a government-issued letter or other document designating the entity as a charitable institution or as performing a charitable purpose (for example, research or education). It might also be a determination from the relevant taxing authority that the entity qualifies for tax-deductible contributions.

• Applicants need not be United States citizens.

• Applicants must have an MD, PhD, MD/PhD, or equivalent and be appointed as faculty (or equivalent) at an academic institution.

• Applicants must have a track record of publication and funding productivity that demonstrates the project can be accomplished by the investigators.

• Research projects may be an extension of ongoing research but cannot overlap with any funded studies unless the applicant clearly demonstrates that new funding will not duplicate existing support.

• Applicants can submit only one LOI.

• Applicants selected for funding will permit OSI to publicize the grant for fundraising purposes, including, but not limited to a five-minute video discussing the research project, photos of lab, and photos of patients participating in clinical trials, where applicable.

• Applications that do not follow the specific grant application instructions and/or submission process will not be considered.

• Applications received after the due date will not be considered.

• Applications which do not fall under OSI’s mission will not be considered.

• Resubmissions: Only one resubmission of a previously reviewed application is permitted.

Sponsor Details

Sponsor Institute/Organizations: Osteosarcoma Institute

Sponsor Type: Corporate/Non-Profit

Address: 3963 Maple Avenue Suite 390 Dallas, TX 75219

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