Between January 2004 and June 2005, the Clinical Trials Working Group (CTWG), a panel of 38 clinical trialists, advocates, and government representatives, conducted a transparent, inclusive evaluation of the cancer clinical trials process. The aim of the assessment was to improve efficiency, decrease redundancy and administrative burdens, and better coordinate activities to enhance the development and delivery of the best therapies to people with cancer. The CTWG’s five-year improvement plan was approved for implementation by the National Cancer Advisory Board (NCAB) in June 2005. Dr. James Doroshow, DCTD director and CTWG chair, is directing the execution the CTWG recommendations.
A full six months ahead of schedule, a new NCI organizational structure, designed to oversee the Institute’s entire clinical trials enterprise, was unveiled at the NCAB February 2006 meeting.
The structural components of the reorganization are the Clinical Trials Advisory Committee (CTAC), the Clinical Trials Operations Committee (CTOC), (QUESTION: IF POSSIBLE, LINK TO SLIDE 10 IN THE PPT PRESENTATION LINK tHAT COMES UP AT CTWG Implementation Update to NCAB ON PAGE http://integratedtrials.nci.nih.gov/) and the Coordinating Center for Clinical Trials (CCCT).
CTAC, the first new NCI advisory committee to the director approved in the past decade, will advise the NCI director on the Institute’s clinical trials program and will include members of the NCAB as well as other NCI advisory boards and additional cancer clinical trials experts. CTAC will oversee implementation of CTWG initiatives, including a review of the system to evaluate and measure the effects of the implementation. CTAC also will provide advice on the use of correlative science funds, additional funding allotted to specific clinical trials for correlative science and quality-of-life studies.
CTOC, an internal NCI committee chaired by the NCI deputy director for clinical and translational sciences, includes the directors of every NCI division, branch, or center involved in clinical trials. Based in the NCI director’s office, CTOC will coordinate clinical trials programs across NCI and will make recommendations to improve cost-effectiveness and reduce duplication and overlap among NCI components involved in clinical trials. CTOC will also evaluate new Requests for Applications and Program Announcements for clinical trials prior to review by the NCI Executive Committee.
CCCT will provide project management for the implementation of all CTWG initiatives. CCCT will support a number of significant activities, including coordinating new disease-specific steering committees for the prioritization of phase III trials, the investigational drug steering committee for phase I and II trials, and working groups that will develop critical new tools for clinical investigators, as well as measures to improve clinical trial operational efficiency.
Two disease-specific cancer steering committees have begun to take shape. In January and June 2006, respectively, the steering committees for gastrointestinal cancers and gynecologic malignancies held their first meetings.
See an overview of the CTWG process.