Karmanos Cancer Institute Clinical Trials Office

Clinical Trials Office

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.

The CTO provides comprehensive clinical trials resources and support to KCI staff and affiliate institutions with the highest priority being the safety of participating patients. The CTO functions to the highest ethical standards ensuring and maintaining compliance of KCI clinical trials with internal policy and external governing bodies.  The primary and continuing goals of the CTO are to:

  • Ensure that all clinical trials conducted at KCI are carried out in strict compliance with the Code of Federal Regulations (CFR) and in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. This is done in conjunction and with oversight by the Wayne State University (WSU) Human Investigation Committee (HIC).
  • Facilitate and optimize accrual to clinical trials by providing well qualified, specifically trained study coordinators and research nurse support to KCI physicians and clinical support staff. 
  • Ensure research coordination by facilitating and optimizing physician-patient-CTO staff interaction, communication and collaboration.
  • Facilitate regulatory approval and oversight to rapidly review and activate appropriate trials. 

The CTO coordinates and ensures compliance to the Data and Safety Monitoring Plan (DSMP) which includes coordination and administrative support to the Protocol Review and Monitoring Committee, the Data and Safety Monitoring Committee and the Quality Assurance Committee.  Additionally the CTO serves as an interface with the protocol specific IRB of record to facilitate preparation of required regulatory documents necessary to expedite timely approval of KCI protocols.  The CTO also coordinates registration and maintenance of all therapeutic protocols to the NCI’s Clinical Trial Reporting Program and ClinicalTrials.gov.  CTO supports NCI-funded peer reviewed protocols, investigator-initiated studies, industry sponsored protocols and National Clinical Trials Network (NCTN) Protocols.  Over 90 FTE’s provide data management services as members of the CTO supporting approximately 350 active protocols.

Leadership

Lawrence E. Flaherty, M.D.

Clinical Trials Office Medical Director

Karmanos Cancer Institute

Hudson-Webber Cancer Research Center

4160 John R Street

Detroit, MI 48201-2014

Assistant's Name: Cheryl Gunnells

Assistant's Phone: 313-576-8715

Assistant's Email: gunnells@karmanos.org

 

 

Contacts

Name Role Phone Email Location
Lawrence Flaherty, MD
Medical Director
 

 
flaherty@karmanos.org