CLINICAL TRIALS SUPPORT RESOURCE

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Linked publications, trials & patents

Abstract

The Clinical Trials Support Resource (CTSR) provides infrastructure support for all aspects of clinical protocol research at MD Anderson. The services of this shared resource encompass submitting, activating, and closing single and multi-centered clinical trials; educating research staff on human subjects/clinical research; auditing and monitoring active clinical trials; and ensuring regulatory compliance of IND studies. The online data management system is maintained by the CTSR. The CTSR complements the activities of the Protocol Review and Monitoring System by supporting the electronic protocol submission and review processes, and the CTSR will manage the transition from the current electronic protocol management system to a new platform called eResearch, which will go live in early 2013. The CTSR is supported by 106 staff members (of which 8 full-time employees receive full or partial support from the CCSG) under the direction of Dr. Aman Buzdar, Vice President for Clinical Research Administration. During the past 5 years, the number of new protocols managed by CTSR has increased by 4% from 4,632 in fiscal year (FY) 2007 to 4,818 in FY 2011. Overall, trials led by MD Anderson investigators contributed to the FDA approval of 19 drugs for initial or new indications. New patient registrations have increased from 28,762 in FY 2007 to 46,262 in FY 2011, and the number of patients enrolled in therapeutic clinical trials has increased by 18%, from 6,219 in FY 2007 to 7,558 in FY 2011. During the last grant year, the funds used to support the CTSR salaries were $442,190 (9%) from the CCSG, $812,112 (16%) from user fees, and $3,742,322 (75%) from MD Anderson. In the next award cycle, the level of support from the CCSG, user fees, and MD Anderson is projected to be closer to 4%, 7%, and 89%, respectively. During this past 5-year funding period, CTSR resources were used by 934 principal investigators affiliated with all 19 CCSG programs. Peer reviewed investigators account for 61% of the utilization and 4% of total costs are requested from the CCSG. Publications cited using the CTSR have appeared in several high impact journals such as N Engl J Med and J Clin Oncol. Future plans include implementation of eResearch, which will serve as the new institutional clinical data enterprise system; coordination and modification of inter-departmental operational processes to further reduce time from submission to activation of clinical trials to 60 days; and further enhancements to the human subjects protection training programs.