Investigator Initiated Trials (IIT) Advisory Committee

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:

1. Support investigators in the planning and scientific development of IITs to improve the feasibility, scientific merit, and success of YCC IITs.
2. 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.
3. Offer consultation to investigators regarding collaboration with external entities, third-party vendors, and internal partners.
4. Facilitate access to protocol development support, project management, regulatory management, statistical support, and budget development resources.
5. Review trial feasibility and financial viability.

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.