Abstract No: 8600
Background: Accrual to NCI CTs is often slower than planned and at times mandating premature closure resulting in loss of valuable resources and delay of scientific progress. The NCI MYSC AWG identified 10 barriers to accrual (BtA) to MM CTs (reimbursement, competing treatment options, treatment at NCI designated sites only, etc.). The NCI-TCES was created to objectively assess CT complexity (study arms, registration/randomization steps, treatment and follow-up complexity and duration, etc.). We evaluated the accrual performance of all previously conducted and currently ongoing (as of 12-31-2013) therapeutic ECOG MM CTs (excluding transplant) utilizing these tools.
Methods: The planned and actual accrual, duration of open enrollment and accrual per month of each selected CT was determined. The NCI-TCES model was applied to each CT and a total score calculated (range 0-18). The 10 NCI MYSC AWG BtA were reviewed as it concerns their relevance for each selected CT and described as unlikely (0), possibly (1) or definitely (2) impacting accrual adversely. A total score was calculated (range 0-20).
Results: 11 ECOG MM CTs were evaluated. 6 of 11 achieved planned accrual goals and 5 of 11 did not due to premature closure due to lack of accrual, less than half of planned accrual per month or more than twice the planned enrollment period. CTs achieving planned accrual performance had a NCI MYSC AWG score average of 4.83 versus 8.0 for those CTs failing accrual goals. The NCI-TCES score was 4.83 versus 4.2, respectively. None of the 6 CTs, which successfully enrolled were identified to have BtA, which definitely impacted accrual adversely versus 3 out of 5 of the CTs which failed planned accrual performance.
Conclusions: In this retrospective analysis of ECOG MM CT accrual performance, the NCI MYSC AWG scoring model correlated well with actual accrual performance. Given its general applicability to therapeutic CTs evaluating any malignant disease, this tool may be useful for prospective accrual performance assessment of planned therapeutic clinical trials.
Author(s): Matthias Weiss, Susanna J. Jacobus, Morie A. Gertz, Nikhil C. Munshi, Sagar Lonial, Shaji Kumar, Rafael Fonseca, Angela Dispenzieri, Martha Lacy, A. Keith Stewart, William R. Friedenberg, Robert A. Kyle, Philip R. Greipp, Vincent Rajkumar; Marshfield Clinic, Marshfield, WI; Dana-Farber Cancer Institute, Boston, MA; Mayo Clinic, Rochester, MN; VA Boston Healthcare System; Dana-Farber Cancer Institute, Boston, MA; Winship Cancer Institute of Emory University, Atlanta, GA; Mayo Clinic, Scottsdale, AZ; Guthrie Clinic-Robert Packer Hospital, Sayre, PA