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

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

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

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.

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.

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