Clinical trial participation among patients enrolled in the Glioma Outcomes Project
Center for Outcomes Research
Age Factors; Brain; Clinical Trials as Topic; Craniotomy; Female; Glioma; Humans; Male; Middle Aged; Multivariate Analysis; Patient Participation; Patient Selection; Prospective Studies; Registries
Health Services Research
BACKGROUND: Patient participation in well-designed and conducted clinical trials enables researchers to test new therapies. An understanding of the variables that possibly influence patient enrollment may help in patient recruitment for future trials. The authors evaluated factors that influenced patient enrollment in clinical trials using a prospective, large, multi-institutional registry of patients with malignant glioma.
METHODS: Data were examined from 708 patients who underwent first or second surgery for a malignant glioma who were enrolled in the Glioma Outcomes Project, which is a prospective observational data base that captures clinical practice patterns. The frequency of clinical trial participation and the variables that may have been associated with trial participation were evaluated. These variables included age, gender, race, household income, educational level, first versus second craniotomy, histology, and whether the patient was treated at an academic institution.
RESULTS: One hundred fifty-one of 708 patients (21.3%) participated in a clinical trial, which was higher than the participation reported typically for patients with other types of primary malignancies. In univariate analysis, race, histology, and first craniotomy were significant between the two groups, with Caucasian patients and patients with glioblastoma histology showing higher participation rates. In a multivariate logistic regression model, significant predictors included young age and glioblastoma multiforme histology.
CONCLUSIONS: The authors present information on factors that may influence clinical trial participation among patients with malignant glioma and compare their data with information described previously on patients with other types of malignant disease. The percent of participation among the patients in the current study was greater than among patients with other primary tumor sites. Strategies should be implemented to improve recruitment to neuro-oncology trials, especially in elderly and minority populations.
Cancer. 2002 May 15;94(10):2681-7.
Chang, Susan M.; Barker, Fred G. Jr.; Schmidt, Meic H.; Sloan, Andrew E.; Kasper, Rachel; Phillips, Leslie; Shih, Karen; Hariharan, Subramanian; Berger, Mitchel; and The Glioma Outcomes Investigators, "Clinical trial participation among patients enrolled in the Glioma Outcomes Project" (2002). Glioma Outcomes Publications. 5.