Implementation of Timeline Reforms Speeds Initiation of National Cancer Institute-Sponsored Trials

Abrams, Jeffrey S.; Mooney, Margaret; Zwiebel, James A.; Korn, Edward L.; Friedman, Steve; Finnigan, Shanda; Schettino, Patricia R.; Denicoff, Andrea; Kruhm, Martha; Montello, Mike; Misra, Ranjita; Ansher, Sherry S.; DiPiazza, Kate; Souhan, Erin; Wickerham, D. Lawrence; Giantonio, Bruce J.; O’Donnell, Robert T.; Sullivan, Daniel M.; Soto, N.; Fleming, Gini F.; Prindiville, Sheila A.; Petryshyn, Ray A.; Hautala, Judith A.; Grad, Oren; Zuckerman, Brian L.; Meyer, Ralph M.; Yao, James C.; Baker, Laurence; Buckner, Jan C.; Hortobágyi, Gabriel N.; Doroshow, James H.

doi:10.1093/jnci/djt137

Cited by 23 publications

(24 citation statements)

References 5 publications

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“…Analyses of accrual to the National Cancer Institute (NCI) cooperative group and Cancer Therapy Evaluation Program (CTEP) studies have identified a long trial concept review times (median 1.5-2.5 years) and a high frequency of poor accrual (up to 71%)(7-9,14). In 2008, the Operational Efficiency Working Group was commissioned to develop guidelines for the NCI trial development processes (14). Despite these efforts on the national level, few data and no guidelines exist at the institutional level.…”

Section: Introductionmentioning

confidence: 99%

Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement

Tang

Sherman

Price

et al. 2017

Clinical Cancer Research

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Purpose Slow-accruing clinical trials delay the translation of basic biomedical research, contribute to increasing healthcare costs, and may prohibit trials from reaching their original goals. Experimental Design We analyzed a prospectively maintained institutional database that tracks all clinical studies at the MD Anderson Cancer Center. Inclusion criteria were: activated phase I-III trials, maximum projected accrual ≥10 participants, and activation prior to March 25, 2011. The primary outcome was slow accrual, defined as <2 participants/year. Correlations of trial characteristics with slow accrual were assessed with logistic regression. Results 4,269 clinical trials meeting inclusion criteria. Trials were activated between January 5, 1981, and March 25, 2011, with a total of 145,214 participants enrolled. Median total enrollment was 16 (interquartile range [IQR]: 5-34), with an average enrollment rate of 8.7 participants/year (IQR: 3.3-17.7). There were 755 (18%) trials classified as slow accruing. On multivariable analysis, slow accrual exhibited robust associations with national cooperative group trials (odds ratio [OR] =4.16, P<0.0001 vs. industry sponsored), time from trial activation to first enrollment (OR=1.13 per month, P<0.0001), and maximum targeted accrual (OR=0.16 per Log10 increase, P<0.0001). Recursive partitioning analysis identified trials requiring more than 70 days (2.3 months)between activation and first participant enrollment as having higher odds of slow accrual (23% vs. 5%, OR=5.56, P<0.0001). Conclusions We identified factors associated with slow trial accrual. Given the lack of data on clinical trials at the institutional level, these data will help build a foundation from which targeted initiatives may be developed to improve the clinical trial enterprise.

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Section: Introductionmentioning

confidence: 99%

Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement

Tang

Sherman

Price

et al. 2017

Clinical Cancer Research

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“…[17][18][19] A recent survey of a Cooperative Group, however, indicated that only approximately one third of sites had a formal mechanism for eligibility screening. 22,23 Further, NCI requires the inclusion of recruitment plans in grant applications. An NCI review of phase III Cooperative Group trials active between 2000 and 2007 found that an estimated 22% would have insufficient accrual because of an inadequate accrual rate.…”

Section: Introductionmentioning

confidence: 99%

Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual

Germain

Denicoff

Dimond

et al. 2014

JOP

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“…In addition to the limited reports focusing on trial performance at single cancer centers, recent analyses focusing on national organizations identified high rates of poor trial accrual (18% to 71%)(8, 9, 11–13) and slow concept development times. (11) An alarming statistic reported by Stensland et al was the enrollment of 48,000 patients on failed NCI cooperative group studies over a 7-year period.…”

Section: Discussionmentioning

confidence: 99%

“…(11) An alarming statistic reported by Stensland et al was the enrollment of 48,000 patients on failed NCI cooperative group studies over a 7-year period. (14) Partially at fault are the overly complex trial development processes, with reports of up to 110 steps to open a trial.…”

Section: Discussionmentioning

confidence: 99%

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual

Tang

Hess

Sanders

et al. 2017

Clinical Cancer Research

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Purpose Information on processes for trials assessing investigational therapeutics is sparse. We assessed the trial development processes within the Department of Investigational Cancer Therapeutics (ICT) at MD Anderson Cancer Center and analyzed their effects on the trial activation timeline and enrollment. Experimental Design Data were from a prospectively maintained registry that tracks all clinical studies at MD Anderson. From this database we identified 2,261 activated phase I-III trials; 221 were done at the ICT. ICT trials were matched to trials from other MD Anderson departments by phase, sponsorship, and submission year. Trial performance metrics were compared with paired Wilcoxon signed rank tests. Results We identified 3 facets of the ICT research infrastructure: parallel processing of trial approval steps; a physician-led research team; and regular weekly meetings to foster research accountability. Separate analyses were conducted stratified by sponsorship (industry [133 ICT and 133 non-ICT trials] or institutional [68 ICT and 68 non-ICT trials]). ICT trial development was faster from IRB approval to activation (median difference of 1.1 months for industry-sponsored trials vs. 2.3 months for institutional) and from activation to first enrollment (median difference of 0.3 months for industry vs. 1.2 months for institutional) (all matched P<0.05). ICT trials also accrued more patients (median difference of 8 participants for industry vs. 33.5 for institutional) quicker (median difference 4.8 participants/year for industry vs. 11.1 for institutional) (all matched P<0.05). Conclusions Use of a clinical research–focused infrastructure within a large academic cancer center was associated with efficient trial development and participant accrual.

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Implementation of Timeline Reforms Speeds Initiation of National Cancer Institute-Sponsored Trials

Cited by 23 publications

References 5 publications

Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement

Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement

Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual

Modifying the Clinical Research Infrastructure at a Dedicated Clinical Trials Unit: Assessment of Trial Development, Activation, and Participant Accrual

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