Dr. Selma Kunitz has repeatedly proven her ability to apply innovative methodology, technology, and organizational structures to the clinical study environment and to provide oversight for study design, implementation, data management, safety monitoring, statistical methodology, and quality assurance. She has led KAI Research, Inc. efforts to develop and implement clinical data management systems that use state-of-the-art technology, perform extensive editing, and integrate project management tools. She has overseen KAI efforts in the development of common data elements (CDE) and data warehouse projects for several National Institutes of Health (NIH) and the pharmaceutical industry. She has also led KAI efforts to introduce risk-based monitoring as a cost-effective, efficient tool for clients.
Dr. Kunitz has more than 35 years of experience in the design, implementation, and management of clinical research projects. She has successfully led and collaborated with multidisciplinary teams of statisticians, epidemiologists, clinical investigators, and programming staff to conduct large, multicenter clinical studies. Furthermore, her services have been requested by numerous Data Safety Monitoring Boards (DSMB) when they identify potential problems that require analysis and a solution.
For the NIH National Institute of Neurological Disorders and Stroke (NINDS), Dr. Kunitz led team efforts to develop a data management and tracking software application for the Institute’s clinical research projects. The system, Clinical Information on Projects System, provides an array of reports which describe ongoing research by type of study, disease area, clinical trial phase, number of participants projected and enrolled, risk, intervention, and other descriptors. The system also provides useful information on budgets and cost effectiveness.
Dr. Kunitz worked with KAI and NINDS staff to create the descriptors that characterize the research and assess the risk to patients in each study. She also led staff in the development of a tracking system for DSMBs and led the development and implementation of CDEs for NINDS. The CDEs, accompanying forms, definitions, and edits, provide a critical core of data to reduce startup time and avoid reinventing the wheel with each study. It also provides the Institute with a format for data receipt once a study is completed. Dr. Kunitz also led KAI efforts to develop data warehouses which use the CDEs to store data and permit aggregate analyses.
Dr. Kunitz has led KAI efforts to develop guidelines and templates for academic investigators funded by the NIH National Institute on Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and National Institute on Aging (NIA) in the conduct of clinical trials. The guidelines include development of a Manual of Operating Procedures (MOP), Safety Monitoring Plans, Data Management Plans, quality control plans, and reports for DSMBs. These guidelines are housed in toolboxes on the Institutes’ websites, and the NIA website has been linked and referred to by many academic and organizational sites.
Dr. Kunitz has also led KAI efforts to conduct process site visits to clinical trials conducted at academic investigators’ sites. The focus of these visits is the translation of the grant application into an operational study with workable procedures, study forms, MOP, data management systems, safety reporting, quality control reports, and recruitment and retention of study participants. Investigators have called upon Dr. Kunitz throughout a study to provide ongoing advice on clinical trial operations.
Dr. Kunitz routinely reviews protocols for the NIA and NIAMS as well as grant applications for study sections. She has developed protocols for multicenter clinical trials. As principal investigator of the National Center for Complementary and Alternative Medicine and NIA contracts, she worked with the project teams to implement studies, train intramural investigators, and develop safety monitoring strategies for multisite international studies.
Dr. Kunitz has been a recognized leader in clinical data management systems. She led KAI efforts to develop and implement clinical data management systems that use state-of-the-art technology, perform extensive editing, and integrate project management tools. She has given presentations and lectures for pharmaceutical trade associations including the Drug Information Association, the Society for Clinical Data Management, and Society for Clinical Trials on quality assurance and data management. She is also experienced in development of outcome and life quality measures, clinical software, and health systems. Her advice on clinical data management is often requested by numerous academic centers and clinical investigators.
Important to clients are Dr. Kunitz’s ability to organize a staff; develop a work plan; and motivate and mentor multidisciplinary teams to work together in a highly effective, task-oriented, problem-solving, open manner. She translates concepts and goals for research and technical staff, develops a plan of work, delegates responsibility, and ensures tasks are accomplished in a highly satisfactory manner.
Dr. Kunitz holds a doctorate of philosophy in organization behavior and social epidemiology from the Johns Hopkins University School of Hygiene and Public Health and a master’s of science in management information systems and organization development from the American University School of Government and Public Affairs. She also holds a bachelor’s of arts in economics from the University of Rochester.