Clinical Trials Office

The Clinical Trials Office’s (CTO) provides support for clinical research at the University of Kansas Cancer Center and for members of the Midwest Cancer Alliance (MCA).  It accomplishes this role by assisting research investigators in the development, activation, and completion of clinical trials, facilitating the clinical research protocol approval process, and ensuring compliance with federal, state, and institutional regulations, policies, and procedures in order to protect the interests of patients and of the University of Kansas.

The purpose of the Clinical Trials Office (CTO) at the University of Kansas Cancer Center is to:

1. Support high quality clinical research that meets the objectives of the University of Kansas Cancer Center and the National Cancer Institute and improves the overall quality of clinical research
2. Assist Cancer Center and Midwest Cancer Alliance investigators in the development, activation, and completion of investigator-initiated, cooperative group, and industry-sponsored clinical trials in an efficient, cost-effective, and scientifically-sound manner 
3. Facilitate the clinical research protocol approval process and ensure compliance with federal, state, and institutional regulations, policies, and procedures in order to protect the interests of patients and of the University of Kansas.

The Clinical Trials Office’s major areas of responsibility include:

• Support for all regulatory requirements such as Institutional Review Board (IRB) submissions and annual reporting, Investigational New Drug (IND) application submissions and annual reporting, and assistance with protocol submissions to the Scientific Review Committee, Human Subjects Protection Committee, Data Safety and Monitoring Committee, and the National Cancer Institute
• Assist with budget development and contracts negotiations and resolution of problems pertaining to resource allocation
• Provide experienced oncology research nursing support to principal investigators in all phases of clinical research
• Provide data management for all SRC approved clinical trials
• Manage seven Disease Working Groups
• Serve as a resource for Cancer Center and Midwest Cancer Alliance members concerning the clinical trials process
• Inform investigators, patients, and the general public of clinical trials opportunities.

For clinical investigators and research coordinators at the University, the CTO offers information about research contracts, how to prepare budgets, and how to complete University forms. The CTO also provides information to help investigators get started with a clinical trial.