Barriers to Clinical Trial Accrual Include Trial Sponsorship and Time to Enrolling First Patient, Study Finds
A study by researchers from The University of Texas MD Anderson Cancer Center investigating factors associated with slow participant accrual into phase I to III cancer clinical trials at their institution has found trials initiated through national cooperative groups and the time taken from trial activation to first patient enrollment were among the factors linked to slow accrual. The findings from this study will help build a foundation to develop targeted initiatives to improve clinical trial participation. The study by Tang et al was published in Clinical Cancer Research.
Study Methodology
The researchers analyzed a prospectively collected clinical study registry at MD Anderson Cancer Center in Houston, Texas, over a 30-year period, from January 1981 to March 2011. The data included 4,269 trials with a combined enrollment of 145,214 patients. Inclusion criteria were activated phase I to III trials, maximum projected accrual ≥ 10 participants, and activation prior to March 25, 2011. Median total enrollment was 16 (interquartile range [IQR] = 5–34), with an average enrollment rate of 8.7 participants per year (IQR = 3.3–17.7).
The primary outcome was slow accrual, defined as fewer than two participants per year. Correlations of trial characteristics with slow accrual were assessed with logistic regression.
Study Findings
The researchers classified 755 trials (18%) as slowly accruing. On multivariable analysis, slow accrual exhibited robust associations with national cooperative group trials (odds ratio [OR] = 4.16, P < .0001 vs industry-sponsored, time from trial activation to first enrollment (OR = 1.13 per month, P < .0001), and maximum targeted accrual (OR = 0.16 per log10 increase, P < .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 < .0001).
Determining the Feasibility of Clinical 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,” concluded the study authors.
In a statement, coauthor of the study J. Jack Lee, PhD, DDS, Associate Vice Provost of Quantitative Research and Professor of Biostatistics at The University of Texas MD Anderson Cancer Center, said, “Despite the best intent and effort, 9% of the trials in our study had zero accrual. These are the trials that we should not even develop to begin with. Doctors and hospitals need to carefully vet the feasibility of a successful study accrual before opening a trial and be more mindful of investing in the areas of highest potential impact in order to maximize the utilization of available resources.”
This study was funded in part by the National Cancer Institute.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
