The Clinical Trials Office (CTO) provides a centralized resource of comprehensive management services for OSUCCC investigators to conduct successful clinical trials in a methodologically sound, expedient and cost-effective manner.
The mission of the CTO is to provide centralized resources to the investigators to successfully conduct cancer clinical trials in a methodologically sound, compliant, expedient and cost-effective manner. The conduct of clinical cancer research has become increasingly complex due to multiple investigational drug combination treatments, their associated correlative studies, an increased number of targeted therapy trials and increasing regulatory oversight. The CTO provides centralized management to bring the necessary expertise into progressively more specialized areas of clinical investigation.
A summary of the resources provided by the CTO includes:
- Protocol development
- Regulatory administration and management
- Trial activation and coordination
- Data management
- Protocol tracking and monitoring
- To provide investigators with assistance in the development of clinical protocols through translation of innovative concepts and ideas into formal, organized documents
- To assist investigators in the preparation and submission of protocols for review by the OSUCCC’s Clinical Scientific Review Committee (CSRC), as well as by The Ohio State University Cancer Institutional Review Board (IRB), the NCI’s CIRB and the Western Institutional Review Board (WIRB)
- To distribute information on active cancer clinical trials to investigators, research and administrative staff, and, through the OSUCCC website, to the general public
- To provide centralized patient registration on all OSUCCC clinical trials
- To collect, maintain and update data on patients enrolled in clinical trials, including but not limited to data on accrual, race, ethnicity and gender
- To oversee the reporting and documentation of adverse events that occur in the context of CTO-managed trials and train the OSUCCC clinical research staff in the recognition and evaluation of these events
- To provide information and administrative support to the CSRC for the initial scientific review of clinical trials and the subsequent evaluation of these trials for their ability to accrue in a timely fashion
- To provide information and administrative support to the Data and Safety Monitoring Committee (DSMC), which monitors the safety of patients enrolled on local investigator-initiated clinical trials
- To assist in the training of investigators and clinical trials staff in the development, conduct and analysis of clinical trials
- To ensure that cancer trials are conducted in accordance with federal, state and institutional regulations
To further compliment this structure, faculty-led Disease Specific Research Groups facilitate the alignment of cancer care and clinical research. This model coordinates efforts within a cancer disease specialty and enhances the development and conduct of trials by multidisciplinary teams.
The overall role of the Disease Leaders is to:
- Design quality clinical trials that will be activated and completed quickly
- Monitor the progress of existing trials
- Encourage multidisciplinary interaction
- Mentor junior faculty
- Assess trial accrual potential and potential overlap between competing trials
- Assist in the identification and allocation of resources for conducting clinical trials
A Regulatory Manager oversees the day-to-day operations of the Regulatory Department that is staffed with Regulatory Compliance Officers (RCOs). As trials receive approval the Clinical Scientific Review Committee, the assigned Regulatory Compliance Officer (RCO) creates the documents to be submitted to the IRB for review.
The RCO works closely with the Principal Investigator to develop trial documents to be submitted and reviewed by either the OSU IRB, NCI’s CIRB or Western Institutional Review Boards. They also work with the PI to submit Investigational New Drug Applications (IND) to the FDA when applicable. The RCO works with the sponsor to generate the required regulatory documents kept on-site and submitted to the sponsor for review and approval.
The RCO continues to monitor and maintain regulatory documents in compliance with institutional, state and federal guidelines.
Trials are submitted at least annually to the IRB for continuing review. Any trials that require an amendment change are processed by RCO and are submitted to the appropriate IRB for review. Any Investigational New Drug Safety Reports are submitted to the appropriate IRB committee for review by the Regulatory Department as per the local IRB’s adverse event submission policy. The Regulatory Department assists with industry-sponsored monitoring visits and auditing preparations for all trials.
Clinical Research Team Managers
The Clinical Research Team Managers provide an essential layer of oversight and training for an increasingly large and complex clinical trials operation at the OSUCCC. They also serve as an important liaison with Faculty Disease Group leaders in fulfilling the research mission of the OSUCCC Disease Specific Research Groups.
The Clinical Research Team Managers’ responsibilities include:
- Participating in the clinical trial portfolio management in conjunction with the Faculty Disease Leader to reflect the research goals, patient resource management and CTO resource allocation of the group Supervising and training of CTO coordinating staff to provide for the efficient and compliant conduct of clinical cancer research trials
- Assisting the CTO medical director and CTO administrative director in aligning and developing CTO resources to match with OSUCCC goals
The CTO employs clinical research specialists (CRS), licensed nurses spread across the disease teams, who provide clinical support to the clinical research coordinators (CRC), who are non-licensed professionals. The coordinating staff report to the clinical research manager and are responsible for all aspects of subject trial management, from screening, enrollment, treatment and long-term follow-up. The coordinating staff participate in the informed consent process, monitor toxicities, oversee treatment administration and ensure that only eligible patients are enrolled onto protocols.
The role of the coordinating staff includes the following:
- Participating with the investigators in the design, writing, feasibility, and review of protocols and consent forms prior to regulatory submission
- Screening of potential patients for protocols through scheduling and reviewing of pre-study tests and procedures
- Confirming eligibility criteria of subjects by reviewing all pre-study testing and subjects’ medical history against the trial’s inclusion/exclusion criteria
- Reinforcing the investigator’s consent form discussion and obtaining and documenting the written subject’s informed consent process
- Registering patients into OnCore, the CTO’s clinical trial management system
- Collaborating with investigators during to ensure protocol adherence monitoring of the subject’s adverse events and providing accurate documentation in the medical records
- Collaborating with the investigator in review of responses
- Timely reporting of Serious Adverse Events to regulatory agencies as defined in the protocol
- Collaborating with the data coordinators regarding data collection
The Clinical Trials Office participates in cooperative group, industry-sponsored and investigator-initiated trials, for which research coordinators and assistants employed by the CTO complete, collect and enter data via databases and online data repositories. Staff training is accomplished both by in-house staff and sponsor-created training programs.
Clinical Trial Informatics Clinical Research Management System
The CTO utilizes OnCore, which has tremendous functionality, including patient and protocol registration, protocol review functions for the Clinical Scientific Review Committee and Data Safety Monitoring Committee, subject visit tracking, workload reporting and trial portfolio reports for disease teams. Training is provided on a regular basis to CTO staff and special workshops are held for PIs.
Web-Based Clinical Trials Access
Through Ohio State’s Wexner Medical Center Intranet, key information on cancer clinical trials is accessible to staff and investigators 24/7.