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Factors influencing enrollment in clinical trials for cancer treatment
C N Klabunde1, B C Springer, B Butler
1Applied Research Branch, National Cancer Institute, Bethesda, Md 20892-7344, USA.
Background:
Recruitment of cancer patients to clinical trials is an ongoing challenge. In this study, we assess factors that may influence enrollment in clinical trials for cancer treatment.
Methods:
Between June 1997 and January 1998, data were collected on all adult cancer patients evaluated for enrollment in National Cancer Institute-sponsored clinical trials at 15 medical facilities in the southeastern United States.
Results:
More than 2,300 cancer patients were evaluated; 7% were enrolled. Neither patient sex nor race predicted enrollment. Patients with fee-for-service coverage were more than twice as likely to be enrolled compared with patients with other types of coverage, including managed care. Patient refusal accounted for the nonenrollment of nearly 40% of those clinically eligible.
Conclusions:
Although multiple factors influence enrollment in clinical trials for cancer treatment, results suggest that insurance coverage plays a role. Patient refusal, a substantial reason for nonenrollment, points to the need for continued efforts to educate physicians and the public in the value of clinical trials.
Insights
Enrollment in cancer clinical trials is challenging. Fee-for-service insurance significantly increases trial participation, while patient refusal remains a major barrier, highlighting the need for better education on clinical trial value.
Area of Science:
- Oncology
- Clinical Trials
- Health Services Research
Background:
- Clinical trial recruitment for cancer patients faces persistent challenges.
- Understanding factors influencing enrollment is crucial for advancing cancer treatment research.
Purpose of the Study:
- To identify key factors affecting patient enrollment in National Cancer Institute-sponsored clinical trials.
- To analyze the impact of insurance type and patient refusal on clinical trial participation.
Main Methods:
- Data collected from over 2,300 adult cancer patients evaluated for clinical trials.
- Study conducted across 15 medical facilities in the southeastern United States between June 1997 and January 1998.
Main Results:
- Only 7% of evaluated patients were enrolled in clinical trials.
- Fee-for-service insurance was associated with over double the enrollment likelihood compared to other insurance types.
- Patient refusal was responsible for nearly 40% of non-enrollment among eligible patients.
Conclusions:
- Insurance coverage, particularly fee-for-service, significantly influences cancer clinical trial enrollment.
- Patient refusal is a substantial barrier, emphasizing the need for enhanced patient and physician education regarding clinical trial benefits.
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