We are advancing ICTR’s Protocol Development Program, using the framework previously established, with new leadership. Dr. Bernadette Gillick (ICTR Director of Research Design) and Dr. Leigh Ann Mrotek (ICTR Clinical Trial Navigator) lead the team. The Protocol Development Program is focused on improving the preparation for faculty investigators to lead clinical trial studies with special attention to improving health equity in participant populations.
The Protocol Development Team provides individualized service to faculty investigators in preparation of protocols for submission to approving organizations (such as the IRB). The navigator works side-by-side with the investigator to provide assistance for protocol preparation and completion and successful navigation of regulatory approval applications (e.g., IRB, FDA). We help the investigator determine which services they need to help with in their research design and planning. We join the investigator during consultations with the service groups and we plan studio think tanks to provide multi-service guidance and assistance.
One of the most important aspects of the assistance we provide is to improve health equity in clinical and translational research projects. Integrating many of the related ICTR resources, we provide guidelines and suggestions for investigators to improve recruiting practices and data analysis methods to be more inclusive of historically underrepresented and underserved populations in research.