In the recent Clinical Translational Science Award strategic planning process and in meetings with representatives for various NIH Institutes, the enhancement and improvement in clinical research management at all stages has been identified as a key goal of the program and for the national research agenda. In this application we are proposing a series of annual conference workshops that will serve as a critical resource in facilitating and advancing interdisciplinary and translational clinical research nationally through promotion of scientific exchange among investigators, regulatory professionals and regulators, IRB administrators, industry, and NIH. The task of planning for and reporting on the workshops will be delegated to the national CTSA Clinical Research Management (CRM) Taskforce and its planning committee. The overall mission of the CRM is to: Make recommendations regarding standard metrics for the CTSA consortium;Develop methodology and specific, practical interventions for implementation at the CTSA sites;Create networks of partners and mentor-mentee relationships;Develop objective evidence of improvement;and Publish information to enable broad application of lessons learned in the scientific community. The conference workshops are geared towards 1) identifying issues which impede the clinical research development process;2) developing innovative strategies for addressing problems encountered;and 3) modifying, implementing and sharing best practices nationally. This information exchange will promote improved methodology for process control, implementation of revised systems for protocol processing, and enterprise-wide use of metrics and information exchange that will allow the CTSA centers to serve as model for reducing regulatory burdens both within sites and between collaborating sites. The 2009 conference will be held on the NIH Campus at the Natcher Building, which includes a 1,000-seat auditorium, and a state-of- the-art multiuse Conference Center with nine conference rooms, and will include networking opportunities, use of posters to provide individual site data and processes and lessons learned, and podium lectures to demonstrate the use of expert advice in re-structuring protocol processing and clinical trials management. The PI, Dr. Robert Sherwin, M.D., will oversee the activities, with overall administration and planning directed by committee Chairs, Dr. Michael Joyner and Ms. Tesheia Johnson who will have responsibilities of chairing the planning meeting, setting milestones to achieve conference timelines, and reporting after the conference. Dr. Daniel Rosenblum, NCRR, and the CTSA coordinating center will provide critical organization infrastructure with responsibilities for scheduling and arranging the conference, circulating agendas and meeting materials, and overall administrative support to the group.
The NIH is dedicated to improving public health by conducting and funding medical research. The information exchange at this conference will promote improved methodology for process control, implementation of revised systems for protocol processing, and enterprise-wide use of metrics with the overall goal of reducing regulatory burdens that hinder Medical research.