MCW Cancer Center Opens Clinical Trials OfficeCTO Administrative Director Betty Oleson, BSN, RN, CCRP and CTO Medical Director, James Thomas, MD, PhD

Celebrating the opening of the Clinical Trials Office (CTO), the Medical College of Wisconsin (MCW) reinforces its position as the area’s premier cancer research and treatment destination.

The Clinical Trials Office at the MCW Cancer Center provides a centralized, comprehensive program of scientific, clinical, financial, legal, and administrative support to the cancer research community at the Medical College of Wisconsin.

The CTO provides a complete package of services for investigators conducting cancer-focused clinical trials.  Approximately 40 staff members work together to support the needs of various disease-focused investigators. The CTO works with the IRB, MCW Physicians, Dynacare, OCRICC, Grants and Contracts, and various other groups that support clinical trials throughout MCW, Froedtert, Children’s Hospital of Wisconsin, and Zablocki VA Medical Center.  The Office also supports clinical cancer trials for several community partners including St. Joseph’s West Bend and Community Memorial Hospital.

Led by James Thomas, MD, PhD, CTO Medical Director, and Betty Oleson, BSN, RN, CCRP, CTO Administrative Director, the Clinical Trials Office represents the total coordination of cancer clinical research at MCW; standardizing efforts throughout MCW and its affiliates. The model fosters multidisciplinary collaboration, increases awareness of cancer clinical trials, and improves outcomes for investigators, patients, and the community. 

Planning and building the CTO has been a massive undertaking.  Clinical trials are extremely complex, and highly regulated, involving many departments, clinical partners, and regulatory teams. Betty Oleson explains:

“It’s eye-opening to see how complex and multi-labor intensive it is to open a clinical trial, and just how many moving parts are involved.  We had to understand all of the processes before we could figure out how to make it work better.”

The large scope and reach of the CTO, while challenging, provided many opportunities for process improvements, streamlining, and standardization to best practices.  For the first time, the processes and standard operating procedures (SOPs) for cancer clinical trials are clearly defined and documented.  This documentation is the foundation of a formalized training and quality assurance program.  Dr. Thomas shares why this is important:

“The defined and documented SOPs allow us to develop a formal training program and get new staff up to speed much more quickly.  You can’t go to college for this, it’s taught on-the-job, so consistent training materials are extremely valuable.”

The CTO simplifies the clinical trial process for investigators by providing a dedicated team of resources, centralized space at the Froedtert Clinical Cancer Center, and specialized expertise and support for investigators--including a new team solely dedicated to handling regulatory issues and budgeting.

“Before there were no resources available with that specialized knowledge, it was almost like starting from scratch with each trial.  Now there are experts in regulatory affairs and budgeting always available, which should reduce the time to establish a trial and free up the coordinators to focus on what they know best.”

Clinical trial resources are now organized by disease, not department, with faculty disease resources overseeing all research in that disease area.  Each disease team is led by a Clinical Research Manager.  After making the decision to organize cancer trials around disease treatment teams, the process began to transition staff and trials to the CTO. Hematology Oncology was the first team brought on board, in January of 2012, Radiation Oncology was aboard by April, and Surgical Oncology completed the transition on July 1, 2012.

The strengths and benefits of the CTO are many.  Andrea Brown, MBA, the Associate Director of Administration in the MCW Cancer Center, is excited about this critical addition to the Cancer Center.

“The Clinical Trials Office allows the MCW Cancer Center to integrate expertise by disease, provide standard operating procedures for clinical research, and maximize economies of scale.  With the majority of cancer trials managed through the CTO, the disease focused teams can best serve the physicians, and ultimately, the patients.”

Even with so much accomplished the CTO looks toward the future.  Over the next weeks and months, the team is working to expand the number of cancer clinical trial offerings at MCW, develop a Cancer Center Training Program, deploy OnCore Clinical Trials Management Software to all faculty and staff, incorporate additional departments/research groups into the CTO, and establish a Cancer Translational Research Unit.

The CTO team is confident that their hard work is worth the effort.  The ability to offer patients consistent, evidence-based treatments and trials is something only available at an academic medical center.  A strong, centralized Cancer Clinical Trials Office means that Froedtert and the Medical College of Wisconsin Cancer Center can offer patients the newest treatments, today. 

The MCW Cancer Center is grateful to Froedtert Hospital, the Froedtert Hospital Foundation and the Kurtis R. Froedtert Trust for their commitment to the CTO and generous financial support.

If you have any comments or questions about the cancer CTO, please contact Betty Oleson, BSN, RN, CCRP, at (414) 805-8218.



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