About the Clinical Trials Office
The Clinical Trials Office provides the clinical research infrastructure which affords Henry Ford Health System patients the opportunity to participate in clinical trials. The CTO supports the multi-disciplinary approach to the services offered. This is accomplished by providing a centralized clinical research support system to all interested departments.
Because of this coordinated effort, the CTO has established both an institutional and national reputation in providing exceptional patient care and quality assurance in the conduct of clinical trials.
Through the mechanisms of the National Cancer Institute (NCI) supported cooperative group program, numerous industry-sponsored, consortium and Henry Ford Health System investigator-initiated clinical trials, eligible Henry Ford Health System patients are offered "state-of-the-art" clinical trials as a treatment option.
The office is under the medical direction of Ding Wang, M.D., Ph.D. and has been the principal investigator for more than 150 clinical trials.
Administrative staff provide oversight of a group of highly trained clinical research professionals who function to ensure that all aspects of the clinical trials processes are maintained at high standards and fulfill all aspects of the federal regulatory requirements.
These individuals are divided into categories of job classifications providing specialized services in the following areas:
Administrative: This group consists of five regulatory coordinators and one financial grant manager. Their primary responsibilities include the activation and maintenance of the approximate 170 clinical research projects supported by the CTO. This requires achieving initial Institutional Review Board approval and subsequent approvals of annual IRB renewals, protocol amendments and safety reports as they become available through the sponsor. Other primary functions include contract and budget negotiations, support and monitoring of affiliate institutions, coordination of multi-institutional clinical research projects, financial oversight of CTO operations, and provision for physician and other clinician educational opportunities.
Research Nursing/ Case Management: As a means of providing clinical support to physician investigators and, in particular, to provide for the technical expertise, education and emotional support to patients registered to clinical trials, eleven registered nurses, three bachelor's prepared research assistants are part of the CTO staff. Through their involvement with the identification and verification of eligible patients and their ongoing scrutiny for protocol compliance, the evaluability of Henry Ford patients registered to clinical trials is consistently at an exemplary level.
Study Coordination/ Data Management: The CTO supports a staff of eight clinical research associates who are assigned to specific therapeutic areas. These individuals provide for the ongoing collection of protocol-specific documentation of patient information. In that capacity, they also work closely with physician investigators, the case management staff and other clinicians to provide for the quality assurance mandated by both federal and institutional requirements. Through the patient data abstraction process (which in many cases continues throughout the lifespan of the patient), they are able to capture and submit to the sponsor the data necessary for the evaluation of efficacy and toxicity of protocol treatments. In addition, ongoing audits (mandated by Food and Drug Administration and National Institutes of Health guidelines) are managed by these individuals to further validate protocol results and the quality assurance mechanisms in place at Henry Ford Health System.
In order to ensure high quality, accurate, and timely data, the CTO employs a full-time QA Specialist, who is also a Registered Nurse and a Certified Clinical Research Coordinator. The QA Specialist ensures ongoing compliance by all staff with the policies and procedures of the site's IRB, federal regulations, ICH GCP, and sponsor requirements, and closely monitors and reviews FDA Guidance documents to ensure research conduct/practice is in line with the FDA's current thinking.
In addition, the QA Specialist ensures that CTO staff are certified in Good Clinical Practice and Human Subject's Protection and trained in Dangerous Goods handling in compliance with IATA guidelines.
Other responsibilities include:
- Conducting in-services to multiple departments and the process of informed consent
- Training, as indicated, when deficiencies in study implementation are identified in various departments
- Assisting with the proper resolution of data discrepancies
- Reviewing expectation reports on a monthly basis to ensure timely submission of CRFs to study sponsors and cooperative groups
- Ensuring data delinquency rate is within acceptable standards as determined by study sponsor/cooperative group and site's expectations
- Assisting with data management when needs are identified
- Conducting periodic chart audits and identifying areas needed for improvement
- Serving as a liaison to outside departments who need guidance on how to conduct research that is in compliance with FDA/GCP/ICH guidelines
- Providing ongoing process improvement training and research education to CTO staff; correcting deficiencies identified during sponsor audits via the implementation of action plans
- Correcting deficiencies identified during sponsor audits via the implementation of action plans