Quick facts and information about the new Clinical Trials Office (CTO) at the MCW Cancer Center
Q: Why is the Clinical Trials Office important for the Medical College of Wisconsin?
A: When cancer patients and their families choose Froedtert and the Medical College of Wisconsin for cancer-related consultation or treatment, they do so knowing they have access to the most promising therapies and advanced treatments available in southeastern Wisconsin.
Similarly, talented scientific and clinical faculty choose MCW knowing their efforts will be supported and advanced by an organization with a strong institutional commitment to cancer research.
Q: What are the benefits of a centralized Clinical Trials Office at the MCW Cancer Center?
A: Our mission is to support, advance, and promote clinical and translational cancer research enterprises at MCW. This provides many significant benefits for patients, for investigators, and for faculty and staff, including:
- Improved and expanded services for our patients
- Greater capacity for trials and participants
- Improved protocol safety
- Accelerated academic development of faculty
- Greater specialization of research staff
- Documented and standardized processes for all trials
- More collaboration across disciplines
- Improved accountability and communication
- Best-practice processes, infrastructure, and competencies that can be applied to the broader MCW research community
Q: What resources are available for investigators?
A: The CTO is an integrated, comprehensive clinical trial support system for clinical research investigators, coordinators, and staff with services and resources for each stage of the clinical trial process including:
- Review protocol feasibility
- Provide regulatory support and compliance monitoring; consent development, document collection, and IRB submission
- Develop trial budgets, provide financial management and contract negotiation
- Activate, coordinate & manage trials
- Promote trials and refer patients
- Coordinate assignment of clinical research personnel
- Screen, enroll, and consent patients
- Coordinate study-related care
- Collect and manage patient data
- Report on results
- Conduct ongoing quality assurance audits
- Monitor and report on adverse events
- Invoice and track revenue
Q: Who is leading the CTO?
A: The Clinical Trials Office is a part of the MCW Cancer Center.
- The Medical Director of the CTO is James Thomas, MD, PhD. You can contact him at (414) 805-4612 or firstname.lastname@example.org
- The Administrative Director of the CTO is Betty Oleson, BSN, RN, CCRP. You can contact her at (414) 805-8218 or email@example.com
Q: Where is the Clinical Trials Office located?
A: The Clinical Trials Office and staff are located on the second, third, and fifth floors of the Froedtert Clinical Cancer Center.
Dr. Thomas and Betty Oleson are located at the MCW Cancer Center Administrative Office in suite 5300, 5th floor, Froedtert Clinical Cancer Center building.
Q: How are clinical trials now organized?
A: There are three disease-based teams. Each team consists of a Clinical Research Manager, Clinical Research Nurses, Clinical Research Coordinators, and Clinical Research Assistants.
- Hematology and Blood and Marrow Transplantation (BMT): Debra Pastorek, Clinical Research Manager
- Solid Tumor: Head & Neck, Neurological, Sarcoma, Thoracic, and Melanoma: Debby Baumgarten, Clinical Research Manager
- Solid Tumor: Breast, GI, GU, and GYN: Phyllis Wattleworth, Clinical Research Manager
In addition to the three disease-focused teams, there is a Regulatory Team that provides cross- functional support to all investigators, and educational and administrative support personnel.
Q: Who do I contact about establishing a new trial?
A: For any new cancer trials, please contact the Clinical Research Manager for your disease team. The process for all clinical trials begins with the team manager.
Q: How do I sign up for/when will I receive training on OnCore, the new clinical Clinical Trial Management System?
A: Faculty training on the OnCore Clinical Trial Management System will begin in late autumn. If you would like to learn more about OnCore’s specifications and capabilities, please contact Sandi Johnson, CTMS Coordinator, 805-4376.
If you have any other questions about the Clinical Trials Office, new trials, or other services available, please contact Betty Oleson, CTO Administrator, or Dr. James Thomas, Medical Director. Betty can be reached at (414) 805-8218 or firstname.lastname@example.org and Dr. Thomas can be reached at (414) 805-4612 or email@example.com.