Rates of withdrawal of consent from cancer clinical trials were less than 10%, according to a multi-site observational cohort study.
Among nearly 12,000 patients from 58 clinical trials, 9% withdrew from their respective trials within 2 years, reported Aminah Jatoi, MD, of the Mayo Foundation for Medical Education and Research at the Mayo Clinic in Rochester, Minnesota, and colleagues.
From 2013 to 2019, 2-year rates of consent withdrawal were 5.7%, 7.6%, 8.5%, 7.8%, 8.4%, 9.5%, and 9.8%, they noted in JAMA Oncology.
Five percent of patients withdrew within 6 months, while 0.9% withdrew consent even before starting the trial intervention.
“The 9% of patients who withdrew consent from their respective clinical trials at 2 years is by no means trivial,” Jatoi and colleagues wrote. “As cancer clinical trials are designed and initiated, all of these factors should be taken into consideration with a planned expansion of sample size to offset anticipated withdrawal of consent.”
Multivariable analyses showed that several factors were associated with a higher likelihood of withdrawal of consent within 2 years from cancer trials, including:
Hispanic ethnicity: OR 1.67, 95% CI 1.30-2.15, P
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