Hispanic ethnicity, older age linked to higher odds of withdrawal from cancer-drug trials
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Key takeaways:
- Other factors associated with greater likelihood of withdrawal of consent included randomized trial design with placebo.
- Use of radiation in a clinical trial appeared associated with increased patient retention.
Rates of withdrawal of consent from cancer clinical trials remained below 10% between 2013 and 2019, according to data published in JAMA Oncology.
Factors associated with increased likelihood of withdrawal from such trials included Hispanic ethnicity and patient age of 75 years or older, as well as randomized trial design that included placebo, researchers wrote.
“Findings of this cohort study are robust, generalizable, and worthy of consideration as cancer clinical trials continue to be thoughtfully designed and executed with the goal of generating meaningful findings for the population at large,” Shauna L. Hillman, MS, a member of the alliance statistics and data management center at Mayo Clinic in Rochester, Minnesota, and colleagues wrote. “Factors associated with withdrawal of consent should be considered when designing trials and should be further studied to learn how they can be favorably modified.”
Background and methodology
Patient withdrawal of consent from a clinical trial can undermine the purpose of the trial, introduce bias between trial arms and lengthen the time to completion, among other potential problems.
Hillman and colleagues conducted the observational cohort study to determine rates of withdrawal of consent from cancer clinical trials and baseline factors associated with patient withdrawal. They defined patient withdrawal as voluntary termination of consent to participate at any time during the conduct of the trial.
The study included 11,993 patients (median age, 62 years; 67% female) who participated in 58 cancer therapeutic clinical trials within the Alliance for Clinical Trials in Oncology between 2013 and 2019. Researchers investigated baseline patient- and trial-based factors for associations with patient withdrawal within the first 2 years using logistic regression models.
Results, next steps
Among the trial participants, 1,060 (9%) withdrew consent from their respective trials within the first 2 years.
Researchers reported 2-year withdrawal rates of 5.7% in 2013, 7.6% in 2014, 8.5% in 2015, 7.8% in 2016, 8.4% in 2017, 9.5% in 2018 and 9.8% in 2019.
Multivariable analyses showed associations of Hispanic ethnicity (OR = 1.67; 95% CI, 1.3-2.15), randomized design trial with placebo (OR = 1.64; 95% CI, 1.38-1.94) and age of 75 years or older (OR = 1.39; 95% CI, 1.12-1.72) with increased likelihood of withdrawal within the first 2 years.
Use of radiation appeared associated with increased patient retention (OR = 0.68; 95% CI, 0.54-0.86).
“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,” researchers wrote.
In an accompanying editorial, Dame Idossa, MD, of the division of hematology, oncology and transplantation in the department of medicine at University of Minnesota Medical School, and colleagues noted the potential of consent withdrawal to impede research progress and harm patients.
“Therefore, it is imperative for investigators and trial sponsors to prioritize patient-centered approaches, address potential barriers to participation, and use appropriate strategies to reduce patient withdrawal of consent,” they wrote. “By doing so, we can ensure that clinical trials are conducted ethically and effectively, and that patient participation remains the cornerstone of medical research.”
References:
- Hillman SL, et al. JAMA Oncol. 2023;doi:10.1001/jamaoncol.2023.1648.
- Idossa D, et al. JAMA Oncol. 2023;doi:10.1001/jamaoncol.2023.1341.
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