New Reporting System Under Way for NCI Clinical Trials
Fulfilling a key recommendation from the NCI Clinical Trials Working Group (CTWG), all clinical trials that receive NCI funding will be registered in a central database as part of the new Clinical Trials Reporting Program (CTRP). The phased launch of this program calls for NCI-designated Cancer Centers to begin registering new intervention trials in October 2009, with other NCI grantees following their lead in January 2010.
This rule applies to any intervention study opened to accrual after January 1, 2009. In 2010, observational, ancillary, and correlative studies will be included.
“It is clearly useful to identify such research, but such a prioritization process can only rationally begin with a shared foundation of comprehensive, up-to-date information,” said CTWG chair Dr. James Doroshow.
The phased launch of CTRP began in early January with five pilot sites: Dana-Farber/Harvard Cancer Center, Mayo Clinic Cancer Center, Wake Forest Comprehensive Cancer Center, Robert H. Lurie Cancer Center at Northwestern University, and the St. Jude Children’s Research Hospital. A larger group will join them in early April, with all grantees scheduled to follow by this fall. The goal is for the CTRP to eventually include all trials, regardless of funding source.
While no grantees will be exempt from registration, three NCI organizations—NCI’s Center for Cancer Research, Cancer Therapy Evaluation Program, and Division of Cancer Prevention—will fulfill this task on behalf of their grantees by entering existing trial information directly into the CTRP. Clinical trial administrators will be able to search the CTRP Web site to find out if their trial has already been registered.
“We want to streamline the process and minimize the reporting burden on our investigators,” said John Speakman, associate director for clinical trials products and programs at the NCI Center for Biomedical Informatics and Information Technology (CBIIT). Federal requirements preclude CTRP from registering trials on ClinicalTrials.gov on behalf of the grantee. However, CTRP staff will summarize data from the trial protocol and other submitted materials to develop a formatted file that the submitting organization can provide to ClinicalTrials.gov.