ArticleJournal of the National Cancer Institute2013
Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials.
Article in Journal of the National Cancer Institute, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed.
- Phase II Pilot Study of Vemurafenib in Patients With Metastatic BRAF-Mutated Colorectal Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Trial
- Publication bias in trials registered in the Australian New Zealand Clinical Trials Registry: Is it a problem? A cross-sectional study.PloS one · 2023Article
- Trial Sponsorship and Time to Reporting for Phase 3 Randomized Cancer Clinical Trials.Cancers · 2020Article
- Model of a Queuing Approach for Patient Accrual in Phase 1 Oncology Studies.JAMA network open · 2020Article
- Current Activities of the Coalition of Cancer Cooperative Groups.Journal of the National Cancer Institute · 2019Article
- Age of Data at the Time of Publication of Contemporary Clinical Trials.JAMA network open · 2018Article
- The importance of greater speed in drug development for advanced malignancies.Cancer medicine · 2018Article
- Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Article
- Functional foods and their role in cancer prevention and health promotion: a comprehensive review.American journal of cancer research · 2017Review
- Article
- The Rare Diseases Clinical Research Network's organization and approach to observational research and health outcomes research.Journal of general internal medicine · 2014Article
- Use of the National Cancer Institute Community Cancer Centers Program screening and accrual log to address cancer clinical trial accrual.Journal of oncology practice · 2014Article
- The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.Journal of oncology practice · 2013Article
Corrections and comments
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Authors and funding
31 authors.
Funding
Abstract
backgroundThe 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.
methodsGiven 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.
resultsThe 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.
conclusionsBased 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.