Report of the Operational Efficiency Working Group of the Clinical Trials and Translational Research Advisory Committee: Compressing the Timeline for Cancer Clinical Trial Activation

摘要

In December 2008, the Operational Efficiency Working Group (OEWG) was established under auspices of the Clinical Trials and Translational Research Advisory Committee (CTAC) to advise the National Cancer Institute (NCI) on strategies to reduce the time required to activate NCI-sponsored Cooperative Group and early drug development trials as well as NCI-Designated Cancer Center investigator-initiated trials. The OEWG is a broadly constituted panel including Cooperative Group Chairs and Cancer Center Directors; clinical investigators, statisticians and protocol specialists; academic and community oncologists; clinical trials leadership and staff from all relevant NCI divisions, programs and centers; representatives of pharmaceutical and biotechnology companies and patient advocacy organizations; and representatives of the Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS) and NCI's Cancer Trials Support Unit (CTSU). Establishment of the OEWG represents the realization of Operational Efficiency New Initiative 2 of the June 2005 Clinical Trials Working Group Report to the National Cancer Advisory Board: 'Identify the institutional barriers that prolong the time from concept approval to accrual of the first patient, and develop solutions for overcoming these barriers.' In addition to this charge, the OEWG was also requested to identify strategies to increase the percentage of studies that reach their accrual targets in a timely fashion. The work of the OEWG was therefore divided into two phases, with the first addressing the reduction of trial activation time and the second addressing timely completion of activated studies. This report describes the first phase of the OEWG's activity and presents the recommended initiatives resulting from that phase.