Clinical Trials Office Karmanos

Clinical Trials Office
at Karmanos Cancer Institute

Karmanos offers more cancer treatments not found anywhere else in Michigan. Today’s clinical trials will lead to tomorrow’s standard of care.

Mission of the Core

The mission of the Clinical Trials Office (CTO) is to provide outstanding support to clinical trials at the Karmanos Cancer Institute with the goal of improving cancer therapy and patient quality of life through research.

Our goal is to offer every Karmanos patient the opportunity to enroll in a clinical trial. 

Goals & Services

The highest priority of the CTO is the safety of participating subjects. The CTO operates according to the highest ethical standards thus ensuring and maintaining compliance with all policies of Karmanos and the relevant external governing bodies. The broad, long-range goals of the CTO over the next grant cycle are to:

• Ensure that all clinical trials conducted at Karmanos Cancer Institute are managed in strict compliance with the Code of Federal Regulations (CFR) and in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines.
  • Coordinating and managing all clinical trials conducted at Karmanos and affiliates in strict compliance with the CFR, ICH GCP standards and internal policy and regulations
  • Ensuring the safety of patients participating in clinical trials
  • Coordinating and tracking National Cancer Institute registrations and annual updates for Karmanos investigators
  • Coordinating registration and maintenance of all therapeutic clinical trials to ClinicalTrials.gov and the National Cancer Institute's (NCI) Clinical Trials Reporting Program (CTRP)
• Facilitate and optimize accrual to clinical trials by providing well-qualified, specifically trained data management and research nurse support to Karmanos physicians and clinical support staff.
  • Facilitating increasing accrual to clinical trials
  • Maintaining protocol registry and accrual data utilizing OnCore®
• Ensure research coordination by facilitating and optimizing physician-patient-CTO staff interaction, communication and collaboration.
  • Increasing awareness and education of all Karmanos and affiliate institution staff in the clinical trials arena
  • Providing high quality research coordination and data management to Karmanos, affiliate institutions and external institutions participating in Karmanos investigator-initiated clinical trials
• Facilitate regulatory approval and oversight to rapidly review and activate appropriate trials.
  • Serving as an interface with the Institutional Review Board (IRB) Wayne State University Human Investigation Committee (WSU HIC) and NCI Central IRB to facilitate preparation of the required consent and HIPAA forms and other regulatory documents necessary to expedite effective and timely approval of Karmanos protocols

Why Clinical Trials are Important

The purpose of clinical trials is to develop improved treatments that cure or control cancer, while providing an improved quality of life. They are necessary to identify more effective interventions before they can be considered standard of care and offered to other patients. Standard of care is defined as the best treatment we have at this time, based on previous research. 

At any given time, Karmanos is conducting an average of 700 cancer-specific clinical trials and research projects.

• Bone Marrow & Stem Cell Transplant Program
• Breast Cancer Program
• Gastrointestinal Oncology
• Genitourinary Oncology
• Gynecologic Oncology
• Head and Neck Oncology
• Immunotherapy
• Malignant Hematology Oncology
• Melanoma Program
• Neuro-Oncology
• Phase I Clinical-Pharmacology Program
• Sarcoma Oncology
• Thoracic Oncology

Phase I Clinical Trials Program

As part of our robust clinical trials program, Karmanos runs a Phase I Clinical Trials program. We are a participating site in the Early Therapeutics Clinical Trials Network (ET-CTN) of the National Cancer Institute.  

The Phase I Clinical Trials program assists with early drug development. Phase I clinical trials provide the initial pieces of critical information about the effect of a new drug on humans, which is necessary for future clinical development. Once the initial Phase I trial is complete, drug development may progress into larger clinical studies that continue to test the safety of the new drug and how well it works in treating a particular type of cancer.

Additional Resources

• ClinicalTrials.gov
• Wayne State University IRB
• NCI Central IRB
• Western IRB

Clinical Trials Office Leadership

Elizabeth Cunningham, MS, CCRP
Interim Vice President, Clinical Trials Office
313-576-8995
cunninge@karmanos.org

Anthony F. Shields, M.D., Ph.D.
Associate Center Director for Clinical Sciences
313-576-8735
shieldsa@karmanos.org

CTO Terminology

All CTO employees have access to information systems/databases to facilitate communication and to ensure easy access to patient information and protocol required source documentation. Cerner’s Citrix (CIS) provides password-protected access to medical records including physician dictations, scheduling, and laboratory, imaging and pathology results.

ON-line COllaborative Research Environment (OnCore®)

The CTO uses OnCore® to administer all clinical trial requirements. OnCore® is a highly secure, web-based, cancer-specific system providing fully integrated clinical trials data management and study administration capabilities. The continuing enhancements provide evolving functionality to strengthen the informatics infrastructure and facilitate the centralized management, monitoring and conduct of all Karmanos' clinical trials.

Development of OnCore® is an ongoing collaborative effort with National Cancer Institute (NCI)-designated cancer centers. Oracle-based OnCore® has significantly improved and expanded the scope of CTO clinical trials management, facilitating patient reporting, protocol compliance, regulatory management and tracking, data management, statistical analysis and total electronic coordination of relevant committees. Centralized oversight of all protocols open at Karmanos the Karmanos Network allows for real-time tracking of activities and events of each protocol and provides information for eligibility and accrual. 

OnCore® Capabilities

Compliance

• Generates clinical trial summaries required for NCI reporting: Data Table 3/Data Table 4 reports;
• Identifies low-accruing protocols or those that have over-accrued for review by the PRMC;
• OnCore® checklists are used to track all required processes prior to a protocol being opened to accrual;  
• OnCore® checklists track participating sites and budgetary and contract detail/status;
• Generates reports used to facilitate QA of subject data entry;
• Provides auditing functionality; and
• Serves as a platform for financial billing calendars

Accrual

• Houses all patient consents and accrual to Karmanos clinical trials generating specific or custom accrual reports;
• Provides an automatically updated list of protocols open to accrual per MDT via the OnCore® flow chart;
• Supports the new Karmanos Clinical Trials iPhone app; and
• Provides a platform for the Study Information Portal (SIP), a public website for external access to basic information of Karmanos clinical trials.

Regulatory Support and Protocol Coordination

• Provides centralized password protected location for protocol–related information including but not limited to: ePRMS submissions, FROC review, QAC functions, informed consent documents, annual renewals, Serious Adverse Events (SAE) and protocol deviations;
• Houses protocol-specific calendars and centralized financial management; and  
• Tracks all active protocols to determine regulatory status (open or closed to accrual or pending approval).
• Support for data management and coordination of investigator-initiated studies:  
• Protocol-specific calendars allow for management and facilitation of protocol compliance and tracking of patient visits;
• Electronic Case Report Forms for customized, protocol-specific data collection; and  
• Facility for external institutions participating in Karmanos investigator-initiated studies to report and manage protocol-specific data.