- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894775
Factors Influencing Inclusion in Digestive Cancer Clinical Trials (INDICT)
Factors Influencing Inclusion in Digestive Cancer Clinical Trials: A Population-based Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dijon, France, 21079
- CHU Dijon Bourgogne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient with digestive cancer residing in Burgundy, France
Exclusion Criteria:
- associated cancer
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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included in a clinical trial
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not included in a clinical trial
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Number of participants included in a clinical trial
Time Frame: within a year after cancer diagnosis
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within a year after cancer diagnosis
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FREROT 2015
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