@article{7ae3db95bd4b434d8f31005b06bd4027,
title = "Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials",
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. 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.",
author = "Abrams, {Jeffrey S.} and Mooney, {Margaret M.} and Zwiebel, {James A.} and Korn, {Edward L.} and Friedman, {Steven H.} and Finnigan, {Shanda R.} and Schettino, {Patricia R.} and Denicoff, {Andrea M.} and Kruhm, {Martha G.} and Mike Montello and Misra, {R. Rita} and Ansher, {Sherry S.} and Dipiazza, {Kate J.} and Souhan, {Erin M.} and Wickerham, {D. Lawrence} and Giantonio, {Bruce J.} and O'Donnell, {Robert T.} and Sullivan, {Daniel M.} and Soto, {Nancy I.} and Fleming, {Gini F.} and Prindiville, {Sheila A.} and Petryshyn, {Ray A.} and Hautala, {Judith A.} and Oren Grad and Zuckerman, {Brian L.} and Meyer, {Ralph M.} and Yao, {James C.} and Baker, {Laurence A.} and Buckner, {Jan C.} and Hortobagyi, {Gabriel N.} and Doroshow, {James H.}",
note = "Funding Information: This effort was supported by grant and contract funds from the National Cancer Institute, National Institutes of Health (U10CA076001 and U10CA031946 to Brigham and Women{\textquoteright}s Hospital; U10CA098543 to Children{\textquoteright}s Hospital of Philadelphia; U10CA021115 to Frontier Science & Tech Research Foundation, Inc; U10CA027469 to Gynecology Oncology Group; U10CA025224 to Mayo Clinic College of Medicine, Rochester; U10CA077202 to Queen{\textquoteright}s University at Kingston; U10CA012027 to NSABP Foundation, Inc; U10CA021661 and U10CA080098 to American College of Radiology; U10CA032102 to University of Michigan at Ann Arbor OPS; U10CA070095 to Johns Hopkins University; U01CA099168 to University of Pittsburgh at Pittsburgh; U01CA132194 to University of Med/Dent NJ-R W Johnson Medical School; U01CA062502 to Case Western Reserve University; U01CA069912 and HHSN261201100099C to Mayo Clinic; U01CA07657 and HHSN261201100070C to Ohio State University; U01CA062490 to Dana-Farber Cancer Institute; U01CA062491 to University of Wisconsin–Madison; U01CA062487 to Wayne State University; U01CA062505 to City of Hope/Beckman Research Institute; U01CA069852 and HHSN261201100071C to University of Chicago; U01CA69856 to Sloan-Kettering Institute of Cancer Research; U01CA132123 to University Health Network; U01CA062461 and HHSN261201100039C to MD Anderson Cancer Center; HHSN261201100010C to Emmes Corporation; HHSN261201100032C to University Health Network, Princess Margaret Hospital; HHSN261201100038C to University of California at Davis; and HHSN261201100100C to H. Lee Moffitt Cancer Center and Research Institute).",
year = "2013",
month = jul,
day = "3",
doi = "10.1093/jnci/djt137",
language = "English (US)",
volume = "105",
pages = "954--959",
journal = "Journal of the National Cancer Institute",
issn = "0027-8874",
publisher = "Oxford University Press",
number = "13",
}