The Clinical Research Office (CRO) oversees the growing and complex clinical research enterprise in the Sidney Kimmel Cancer Center (SKCC). The SKCC Clinical Research Office will oversee and coordinate all the clinical research operations in the SKCC and supports the 1) Early Drug Development Unit , 2) Clinical Trials Office and 3) Regional Network Trials.
Each of these divisions has defined roles and responsibilities and led by a physician leader and senior director.
Early Drug Development Unit
The Early Drug Development Unit (EDDU) conducts all non-disease specific phase I studies in SKCC, responsible for the phase I\II contract\consortium with John Hopkins (EDCTN). They will also be responsible for fostering closer relationship with Sarah Cannon by bring novel phase I drugs to SKCC and be the conduit to refer novel phase II cancer specific trials to the appropriate disease management team. This unit will also lead the Molecular Targeted Therapy effort through the Foundation Medicine Consortium, ECOG\NCI Match trial and other molecular targeted basket trials.
Clinical Trials Office
The Clinical Trials Office (CTO) oversees all disease specific trials based on the disease management disease groups. There are seven disease teams (GI, Aero-digestive, Hematologic Malignancies, Women’s Cancers; GU, Melanoma and Cutaneous Melanoma, Solid Tumor ( this includes other malignancies that do not have a substantial clinical research volume at this time to support their own disease team. Based on established metrics, a new disease team may be formed if they meet or succeed these pre-defined metrics.) Each disease management team has a physician leader and co-leader who with work with the senior director to oversee the clinical trial portfolio, clinical trials productivity, management of personnel and oversight of the clinical research budget of the disease group.
Regional Network Trials
The Regional Network Trials coordinates our clinical trials efforts with our regional partners in the SKCC Network Affiliates but also increase our collaboration with Abington Hospital and Lankanau Institute of Medical Research (LIMR).
Clinical Research Office
The Clinical Research Office is overseen by an executive director that will coordinate the activities between the three research divisions and the director will report to the Associate Director of Clinical Research and Clinical Research Advisory Committee in the SKCC. To further support clinical research office there is a Clinical Trials Support Unit and Office of Quality Assurance\ Training that will report the appropriate oversight committees.
Office of Quality Assurance & Training
The Office of Quality Assurance and Training is an administrative arm of SKCC dedicated to the management and coordination of the Center’s Protocol Review and Monitoring (PRMS) and Data and Safety Monitoring (DSM) functions in order to support, facilitate, and assure the highest quality clinical research at SKCC. Two major components provide for clinical research review and oversight: the Protocol Review Committee (PRC) and the Data and Safety Monitoring Committee (DSMC), and the office manages and tracks all committee and related activities. These committees are responsible for reviewing and monitoring all cancer clinical protocol science, designs and analyses, use of Center resources, continued progress, and data and safety compliance. The Office of Quality Assurance and Training also provides an ongoing training and education program for clinical research staff in conjunction with the Jefferson Clinical Research Institute (JCRI) to assist them in managing clinical trials and complying with regulatory requirements.
Clinical Trials Support Unit
The Clinical Trials Support Unit will support the feasibility assessment evaluation, clinical trial prioritization schema\SWOT team, protocol development of IIT\protocol writer\editor, development of protocol approval timelines, data analytics\reports and support the development of electronic submission/data transfer/EMR (research).