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Strategies to overcome barriers to accrual (BtA) to NCI-sponsored clinical trials: A project of the NCI-Myeloma Steering Committee Accrual Working Group (NCI-MYSC AWG).
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: Accrual to NCI clinical trials(CT)is often slower than planned at times mandating premature closure resulting in loss of valuable resources and delay of scientific progress. Methods: The NCI-MYSC AWG identified 10 potential BtA. SWOG, ECOG and Alliance investigators were queried and agreed that these barriers impede accrual (results stratified for academic and community sites). The MYSC AWG developed in collaboration with NCI and FDA strategies to overcome these barriers. Results: Strategies listed for the 3 most often cited BtA: 1. Reimbursement for CT related expenses:increase awareness of improved reimbursement for phase II CT; tailor reimbursement according to CT complexity; request funds from industry and other sources (
Abstracts by M. Weiss:
The PRONTO amyloidosis study: A randomized, double-blind, placebo-controlled, global, phase 2b study of NEOD001 in previously treated subjects with light chain amyloidosis and persistent cardiac dysfunction.Meeting: 2016 ASCO Annual Meeting | Abstract No: TPS8073
- Meeting: 2015 ASCO Annual Meeting | Abstract No: 6600
Cardiac and renal biomarker responses in a phase 1/2 study of NEOD001 in patients with AL amyloidosis and persistent organ dysfunction.Meeting: 2015 ASCO Annual Meeting | Abstract No: 8514