Clinical trial characteristics and barriers to participant accrual: The MD Anderson cancer center experience over 30 years, a historical foundation for trial improvement

Chad Tang, Steven I. Sherman, Mellanie Price, Jun Weng, Suzanne E. Davis, David S. Hong, James C. Yao, Aman Buzdar, George Wilding, J. Jack Lee

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1414-1421
Number of pages8
JournalClinical Cancer Research
Volume23
Issue number6
DOIs
StatePublished - Mar 15 2017

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

MD Anderson CCSG core facilities

  • Biostatistics Resource Group

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