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.
authors.affiliation: Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD 20852, USA. abramsj@mail.nih.gov
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Abrams
authors.forename: Margaret M
authors.initials: MM
authors.lastname: Mooney
authors.forename: James A
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authors.lastname: Zwiebel
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authors.forename: Andrea M
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authors.lastname: Misra
authors.forename: Sherry S
authors.initials: SS
authors.lastname: Ansher
authors.forename: Kate J
authors.initials: KJ
authors.lastname: DiPiazza
authors.forename: Erin M
authors.initials: EM
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authors.lastname: Giantonio
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authors.lastname: O'Donnell
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Sullivan
authors.forename: Nancy I
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authors.forename: Ray A
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authors.lastname: Petryshyn
authors.forename: Judith A
authors.initials: JA
authors.lastname: Hautala
authors.forename: Oren
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authors.lastname: Grad
authors.forename: Brian L
authors.initials: BL
authors.lastname: Zuckerman
authors.forename: Ralph M
authors.initials: RM
authors.lastname: Meyer
authors.forename: James C
authors.initials: JC
authors.lastname: Yao
authors.forename: Laurence A
authors.initials: LA
authors.lastname: Baker
authors.forename: Jan C
authors.initials: JC
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mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards* / Q000639:trends; D017321:Clinical Trials, Phase I as Topic / Q000592:standards; D017322:Clinical Trials, Phase II as Topic / Q000592:standards; D017326:Clinical Trials, Phase III as Topic / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods / Q000592:standards* / Q000639:trends; D054547:National Cancer Institute (U.S.); D013997:Time Factors; D014481:United States