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Investigator-Initiated Trials

Investigator-Initiated Trials

Supporting new ideas in clinical and translational research

IUSCCC is committed to supporting clinical and translational research, particularly investigator-initiated trials (IITs).

While we assume that investigators will first apply for external support for use other internal sources of support (start-up funds, philanthropy, pilot funding, etc.), additional support is sometimes needed to allow high priority IITs to proceed.

IIT pilot program information

The application should be a maximum of three pages.

Study title
Key collaborators
Scientific rationale
Hypothesis
Objectives
Patient population (major criteria only)
Treatment or intervention
Statistical plan and sample size justification
Embedded correlatives/biomarkers
References (not included in page limit)

Input from the Translational Research Core is strongly encouraged.

NIH biosketch (PI and key collaborators only).
Budget and total funding requested.
Other support available for this proposed trial.
Letter from division chief or department head confirming that no start-up or discretional funds are available.
Commitment to external funding – if submitted and not funded, please provide prior reviews. What are your plans for external funding and how will this support increase your chances of success?

Evaluation criteria will include:

Scientific merit
Novelty
Strength of collaboration
Potential for external funding

Please submit applications to Mario Contreraz at contrmar@iu.edu.

Applications will be accepted on a rolling basis with funding decisions made quarterly (September, December, March, June) by the IUSCCC Executive Committee.
Please do not submit the full protocol. Applications can be submitted at any time during the protocol development process, but early application is encouraged to avoid delays.
Trials approved by the SRC without funding will be placed on administrative hold until support is obtained.
Funding will be limited to support CTO services.

Recent awardees

Timothy Lautenschlaeger: Phase I/II trial evaluating five fraction SABR dose escalation for early-stage Squamous Cell Carcinoma of the Lung
Jessica Yesensky: CTO-OTHN-CC-IUSCC-0741 Sentinel lymph node biopsy for cutaneous squamous cell carcinoma of the head and neck
Gordon Watson: IUSCC-0710 Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study
Jordan Holmes: IUSCC-0765: Real-Time Monitoring of Patient Centered Outcomes in English And Non-English-Speaking Patients Undergoing Radiation Treatment and its Impact on Overcoming Language Barriers
Naoyuki Saito:
- IUSCCC- 0787- Patient Satisfaction and Outcomes Following Completion of Radiation Therapy for Breast Cancer in African-Americans
- IUSCCC- 0763 Prospective Validation of a Points Score System Predicting 30-day Survival for Patients with Metastatic Cancer Receiving Palliative Radiation Therapy
Michael Sim: OTHN-CC-IUSCCC-0756 Adjuvant Treatment Deintensification after Transoral Surgery for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx

Questions?

Questions about the application or review process should be directed to Kathy Miller, associate director for clinical research, at kathmill@iu.edu.

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Indiana University Melvin and Bren Simon
Comprehensive Cancer Center

Investigator-Initiated Trials

Supporting new ideas in clinical and translational research

IIT pilot program information

Recent awardees

Questions?

#ResearchCuresCancer

Additional links and resources

Investigator-Initiated Trials

Supporting new ideas in clinical and translational research

IIT pilot program information

Application requirements

Additional materials required

Evaluation criteria

How to apply

Recent awardees

Questions?

#ResearchCuresCancer

Indiana University Melvin and Bren Simon Comprehensive Cancer Center resources and social media channels

Additional links and resources