Associate Professor of Internal Medicine (Medical Oncology); Assistant Medical Director, Clinical Trials Office
Investigator Initiated Trials (IIT) Advisory Committee
Purpose/Mission
The mission of the Yale Cancer Center (YCC) Investigator Initiated Trial (IIT) Advisory Committee is to support IIT protocol development to ensure YCC-investigator initiated research is highly successful and impactful.
The IIT Review Committee functions to:
- Support investigators in the planning and scientific development of IITs to improve the feasibility, scientific merit, and success of YCC IITs.
- Create and foster a research culture that yields highly impactful YCC-investigator initiated research which aligns with the YCC mission and meets the needs of the catchment area.
- Offer consultation to investigators regarding collaboration with external entities, third-party vendors, and internal partners.
- Facilitate access to protocol development support, project management, regulatory management, statistical support, and budget development resources.
- Review trial feasibility and financial viability.
Review
The YCC IIT Advisory Committee is charged with the reviewing all cancer and cancer-related, investigator initiated, clinical trials proposed at Yale. The IIT Advisory Committee has a two-phased review. The initial review is at the concept level. This review should be done as soon as an Investigator begins considering an IIT. The second review is after the protocol is developed. The IIT Advisory Committee’s review encompasses the project’s scientific impact, proposed design, participant enrollment and impact on local patient needs, as well as considerations for engagement of external funders and collaborators, financial factors, and regulatory implications.
The IIT Advisory Committee functions to assign Investigators resources to support development of IIT protocols, and corresponding protocol documents, as well as to connect investigators to staff who will assist in the regulatory, administrative, and operational steps towards trial initiation.
Frequently Asked Questions
- When should I submit a concept for review?
We encourage you to submit your concept as soon as possible. This initial concept review is meant to be an informal setting to discuss your IIT concept and does not require a significant amount of preparation. The IIT Advisory Committee is a resource for scientific feedback from colleagues at YCC, and if your concept is accepted, the IIT Advisory Committee will connect you with resource to support development of your study protocol, drafting corresponding documents, budget development, regulatory submissions, and operational plans.
- How do I submit a concept for consideration?
To submit a concept for review at a IIT Advisory Committee meeting use the IIT Advisory Committee Concept Submission Form. You will be invited to present at an upcoming meeting. You will be asked to present 3-4 slides containing and overview of the project. Please email iit.committee@yale.edu for the slide deck template.
- When does the IIT Advisory Committee Meet?
IIT Advisory Committee Meetings occur the 1st and 3rd Friday of each month. Submission deadlines are posted below.
- What should I expect during the review?
Committee members will discuss the concept with you during the meeting. After the scientific portion, there will be an operational discussion regarding relevant aspects of your project including budgetary considerations, regulatory submission requirements (FDA & IRB), and any unique project characteristics that could impact your start up timeline.
- What is required for the second IIT Advisory Committee review?
After your protocol is in final draft, and your full budget has been developed (including MCA), the following documents will be submitted to the committee via email.
- Submission Ready Protocol
- Full Cost Budget
- Total Funding Committed
- A Letter of Intent from all applicable parties (Manufacturer providing IP and/or Funding Agent)
Important Documents
Committee Chair
2024 Meeting Dates and Submission Deadlines
| Meeting Dates | Submission Deadline |
|---|---|
| Friday, January 05, 2024 | Friday, December 22, 2023 |
| Friday, January 19, 2024 | Friday, January 12, 2024 |
| Friday, February 02, 2024 | Friday, January 26, 2024 |
| Friday, February 16, 2024 | Friday, February 09, 2024 |
| Friday, March 01, 2024 | Friday, February 23, 2024 |
| Friday, March 15, 2024 | Friday, March 08, 2024 |
| Friday, April 05, 2024 | Friday, March 29, 2024 |
| Friday, April 19, 2024 | Friday, April 12, 2024 |
| Friday, May 03, 2024 | Friday, April 26, 2024 |
| Friday, May 17, 2024 | Friday, May 10, 2024 |
| Friday, June 07, 2024 | Friday, May 31, 2024 |
| Friday, June 21, 2024 | Friday, June 14, 2024 |
| Friday, July 05, 2024 | Friday, June 28, 2024 |
| Friday, July 19, 2024 | Friday, July 12, 2024 |
| Friday, August 02, 2024 | Friday, July 26, 2024 |
| Friday, August 16, 2024 | Friday, August 09, 2024 |
| Friday, September 06, 2024 | Friday, August 30, 2024 |
| Friday, September 20, 2024 | Friday, September 13, 2024 |
| Friday, October 04, 2024 | Friday, September 27, 2024 |
| Friday, October 18, 2024 | Friday, October 11, 2024 |
| Friday, November 01, 2024 | Friday, October 25, 2024 |
| Friday, November 15, 2024 | Friday, November 08, 2024 |
| Friday, December 06, 2024 | Friday, November 29, 2024 |
| Friday, December 20, 2024 | Friday, December 13, 2024 |
Questions
For questions, please email us.