title: Clinical Trial Characteristics and Barriers to Participant Accrual: The MD Anderson Cancer Center Experience over 30 years, a Historical Foundation for Trial Improvement.
abstract: Purpose:Slow-accruing clinical trials delay the translation of basic biomedical research, contribute to increasing health care 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 (Houston, TX). 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 per year. Correlations of trial characteristics with slow accrual were assessed with logistic regression.Results:A total of 4,269 clinical trials met inclusion criteria. Trials were activated between January 5, 1981, and March 25, 2011, with a total of 145,214 participants enrolled. Median total enrolment was 16 [interquartile range (IQR), 5-34], with an average enrolment rate of 8.7 participants per 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 (OR = 4.16,P< 0.0001 vs. industry sponsored), time from trial activation to first enrolment (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 enrolment 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.Clin Cancer Res; 23(6); 1414-21. ©2017 AACR.
authors.affiliation: Department of Radiation Oncology, MD Anderson Cancer Center, Houston, Texas. jjlee@mdanderson.org ctang1@mdanderson.org.
authors.forename: Chad
authors.initials: C
authors.lastname: Tang
authors.affiliation: Department of Endocrine Neoplasia and Hormonal Disorders, MD Anderson Cancer Center, Houston, Texas.
authors.forename: Steven I
authors.initials: SI
authors.lastname: Sherman
authors.affiliation: Office of Vice Provost for Clinical and Interdisciplinary Research, MD Anderson Cancer Center, Houston, Texas.
authors.forename: Mellanie
authors.initials: M
authors.lastname: Price
authors.affiliation: Department of Biostatistics, MD Anderson Cancer Center, Houston, Texas.
authors.forename: Jun
authors.initials: J
authors.lastname: Weng
authors.affiliation: Office of Vice Provost for Clinical and Interdisciplinary Research, MD Anderson Cancer Center, Houston, Texas.
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Davis
authors.affiliation: Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston, Texas.
authors.forename: David S
authors.initials: DS
authors.lastname: Hong
authors.affiliation: Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
authors.forename: James C
authors.initials: JC
authors.lastname: Yao
authors.affiliation: Department of Breast Medical Oncology, MD Anderson Cancer Center, Houston, Texas.
authors.forename: Aman
authors.initials: A
authors.lastname: Buzdar
authors.affiliation: Office of Vice Provost for Clinical and Interdisciplinary Research, MD Anderson Cancer Center, Houston, Texas.
authors.forename: George
authors.initials: G
authors.lastname: Wilding
authors.affiliation: Department of Biostatistics, MD Anderson Cancer Center, Houston, Texas. jjlee@mdanderson.org ctang1@mdanderson.org.
authors.forename: J Jack
authors.initials: JJ
authors.lastname: Lee
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000188:drug therapy* / Q000453:epidemiology* / Q000473:pathology; D018579:Patient Selection; D012107:Research Design; D014481:United States