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

Autor:	Abrams JS; Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD 20852, USA. abramsj@mail.nih.gov, 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
Jazyk:	angličtina
Zdroj:	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.
DOI:	10.1093/jnci/djt137
Abstrakt:	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. 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. 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. 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.
Databáze:	MEDLINE
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