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


METHODS
Prospective study conducted at the Tertiary Cancer Centre (India).


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.


METHODS
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.
Department of Radiation Oncology, Epidemiology and Clinical Trial Unit, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai, Maharashtra, India. vmurthy@actrec.gov.in
Vedang
V
Murthy
Kasturi R
KR
Awatagiri
Pramod K
PK
Tike
Sarbani
S
Ghosh-Laskar
Tejpal
T
Gupta
Ashwini
A
Budrukkar
Mandar S
MS
Deshpande
Devendra A
DA
Chaukar
Gouri H
GH
Pantavaidya
Jai Prakash
JP
Agarwal
D000970:Antineoplastic Agents / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy*; D057240:Patient Preference; D018579:Patient Selection; D012107:Research Design
D000970:Antineoplastic Agents