Factors Influencing Inclusion in Digestive Cancer Clinical Trials
Factors Influencing Inclusion in Digestive Cancer Clinical Trials
Since the early 1990s, evidence-based medicine has played an increasingly important role in
 decision-making for the treatment of patients with cancer. The highest level of evidence is
 attributed to the results of randomized comparative studies, and the public health
 authorities require proof from randomized therapeutic trials before authorizing the use of
 new treatments. Patients included in therapeutic trials benefit either from the best current
 treatment (control group) or from a treatment supposed to present a better or similar
 efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a
 randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize
 the fight against cancer, French public health policies have led to the progressive
 implementation of successive nationwide "Cancer Plans" since 2003. One of the objectives is
 to increase the proportion of patients included in clinical research trials. Thus, the
 fraction enrolled in France has progressively increased but remained low at around 8% in
 2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a
 context of socio-economic inequalities that concern resources, residence and access to
 services, identifying factors that determine inclusion in trials will in turn highlight the
 reasons for non-inclusion.

 The aim of this study was to determine, at a population level, the influence of demographic
 characteristics and socio-economic status of patients with digestive cancer on inclusion in a
 clinical trial.

 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.
Inclusion Criteria:

 -  patient with digestive cancer residing in Burgundy, France

 Exclusion Criteria:

 -  associated cancer