Factors influencing inclusion in digestive cancer clinical trials: A population-based study.

Background: Inclusion in a randomized therapeutic trial represents an optimal therapeutic strategy.

Aims: To determine the influence of demographic characteristics and deprivation on the enrolment of patients in digestive cancer clinical trials.

Methods: Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.

Results: Patients aged over 75 years were significantly less likely to be included in clinical trials than younger patients (odds ratio 0.33; [0.13-0.87]). Patients treated in private institutions were also less likely to be enrolled than those treated in public institutions (odds ratio 0.04; [0.01-0.16]; p<0.001). A relationship between type of institution and the European deprivation index was observed (p=0.017). Deprived patients were less likely to be included in clinical trials when they were managed in private institutions (odds ratio 0.706; [0.524-0.952]; p=0.022). The European deprivation index had no impact when patients were managed in other institutions.

Conclusion: The relationship between type of institution and deprivation underlines the necessity for improving patients' chance of being recruited in digestive cancer clinical trials.