A multidisciplinary investigation of cancer clinical trial activation processes at a National Cancer Institute-designated cancer center identified “barriers, non–value-added time, and perceived bottlenecks.” The findings from this study were published in JCO Oncology Practice.
Delays in clinical trial activation can interfere with accrual goals, slow the development of innovative cancer therapies, and have negative impacts on patient survival.
In this study, conducted at The University of Texas Southwestern (UTSW) Medical Center Harold C. Simmons Comprehensive Cancer Center (SCCC) in Dallas, Texas, a multidisciplinary team, including principal investigators, SCCC leadership, and representatives from institutional research administration, the institutional review board (IRB), the SCCC clinical research organization, and sponsored programs, developed “process maps” describing the steps associated with SCCC clinical trial activation and the durations of time needed to conduct these processes.
“We sought to understand reasons for delays in activating clinical trials at our institution and to use this information to redesign our center’s trial activation process and reduce the time to activation of new clinical trials,” the study authors noted.
For this investigation, the starting point of clinical trial activation was defined as the time when the study packet containing the final clinical trial protocol, consent forms, investigator’s brochure, contract, and budget was received at the study site. The time when the first patient was enrolled on the trial at SCCC was designated as the endpoint of the clinical trial activation period.
Four process domains were identified by the team which covered the IRB, ancillary service review, contracts/sponsor, and other.
A major finding of the study was that the longest step in the clinical trial activation process, requiring an average of 80 to 90 days, involved sequential regulatory review by the SCCC scientific review panel followed by the IRB.