Prospective analysis of reasons for non-enrollment in a phase III randomized controlled trial.

ABSTRACT

AIM: This study aims to provide information on the accrual rate and to identify the reasons for non-enrollment of oral cancer patients into a clinical trial. SETTING AND DESIGN: Prospective study conducted at the Tertiary Cancer Centre (India). MATERIALS AND METHODS: Patients eligible and screened for the oral cancer adjuvant therapy (OCAT) were logged prospectively and reasons for non-enrollment were documented which were broadly divided into patient and trial related. STATISTICAL ANALYSIS USED Demographic characteristics of the non-enrolees were compared with the enrolled. Factors predicting non-enrollment were analyzed using multivariate logistic regression test. RESULTS: A total of 1335 patients with locally advanced cancer of the oral cavity were screened of whom 498 (37%) could be enrolled. Among non enrolled 837 patients, 182 (22%) had the trial-related reasons and 655 (78%) had patient-related reasons. Most important patient-related reasons were patients' preference of taking treatment closer to their native place (26.2%), lack of interest (16.8%) in trial participation. Anticipated poor compliance to treatment (5.9%) and follow-up (6.6%), inability to start treatment in time (6.2%) were important trial-related reasons for non-enrollment. Multivariate analysis identified the genders (female), education (illiterate), occupation (laborer) and non availability of support system in the city as significant predictors of non-enrollment. CONCLUSIONS: Both trial design and patient factors were important causes of non enrollment in eligible patients. Patients' need for being closer to home and refusal to participate were the most common reasons for non-enrollment.