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Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials.

Authors :
Abrams JS
Mooney MM
Zwiebel JA
Korn EL
Friedman SH
Finnigan SR
Schettino PR
Denicoff AM
Kruhm MG
Montello M
Misra RR
Ansher SS
DiPiazza KJ
Souhan EM
Wickerham DL
Giantonio BJ
O'Donnell RT
Sullivan DM
Soto NI
Fleming GF
Prindiville SA
Petryshyn RA
Hautala JA
Grad O
Zuckerman BL
Meyer RM
Yao JC
Baker LA
Buckner JC
Hortobagyi GN
Doroshow JH
Source :
Journal of the National Cancer Institute [J Natl Cancer Inst] 2013 Jul 03; Vol. 105 (13), pp. 954-9. Date of Electronic Publication: 2013 Jun 17.
Publication Year :
2013

Abstract

Background: The National Cancer Institute (NCI) organized the Operational Efficiency Working Group in 2008 to develop recommendations for improving the speed with which NCI-sponsored clinical trials move from the idea stage to a protocol open to patient enrollment.<br />Methods: Given the many stakeholders involved, the Operational Efficiency Working Group advised a multifaceted approach to mobilize the entire research community to improve their business processes. New staff positions to monitor progress, protocol-tracking Web sites, and strategically planned conference calls were implemented. NCI staff and clinical teams at Cooperative Groups and Cancer Centers strived to achieve new target timelines but, most important, agreed to abide by absolute deadlines. For phase I-II studies and phase III studies, the target timelines are 7 months and 10 months, whereas the absolute deadlines were set at 18 and 24 months, respectively. Trials not activated by the absolute deadline are automatically disapproved.<br />Results: The initial experience is encouraging and indicates a reduction in development times for phase I-II studies from the historical median of 541 days to a median of 442 days, an 18.3% decrease. The experience with phase III studies to date, although more limited (n = 25), demonstrates a 45.7% decrease in median days.<br />Conclusions: Based upon this progress, the NCI and the investigator community have agreed to reduce the absolute deadlines to 15 and 18 months for phase I-II and III trials, respectively. Emphasis on initiating trials rapidly is likely to help reduce the time it takes for clinical trial results to reach patients in need of new treatments.

Details

Language :
English
ISSN :
1460-2105
Volume :
105
Issue :
13
Database :
MEDLINE
Journal :
Journal of the National Cancer Institute
Publication Type :
Academic Journal
Accession number :
23776198
Full Text :
https://doi.org/10.1093/jnci/djt137