Criteria Associated With Patient Willingness to Participate in Biomedical Research
NCT ID: NCT03098303
Last Updated: 2020-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2014-12-23
2016-12-13
Brief Summary
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Detailed Description
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* To compare patient acceptance rates for participation in a clinical research protocol before and after January 15, 2016.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) before January 15, 2016.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) after January 15, 2016.
* To describe the patient population seen during pneumology consultations.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by a pharmaceutical laboratory.
* To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by an academic institution.
* Construct clusters (homogeneous groups) of patients seen during the pneumology consultations.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Eligibility Criteria
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Inclusion Criteria
* The patient is scheduled for a consult in the pneumology department
Exclusion Criteria
* The patient expresses opposition to the study
* It is impossible to correctly inform the patient about the study
* The patient cannot fluently read French
* The patient is pregnant
* The patient is breastfeeding
* The patient has cancer
* The patient is consulting in tabaccology
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Arnaud Bourdin, MD, PhD
Role: STUDY_DIRECTOR
Montpellier University Hospitals
Locations
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Polyclinique Saint-Privat
Boujan-sur-Libron, , France
Clinique de Marignane
Marignane, , France
APHM - Hôpital Nord
Marseille, , France
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Countries
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References
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Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug 13;21(1):72. doi: 10.1186/s12910-020-00509-y.
Molinari N, Suehs C, Vachier I, Pahus L, Halimi L, Gamez AS, Chanez P, Bourdin A. Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials. Clin Trials. 2019 Aug;16(4):440-442. doi: 10.1177/1740774519840268. Epub 2019 Mar 29. No abstract available.
Related Links
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The PROTOACCEPT patient questionnaire
PROTOACCEPT on the Open Science Framework
Other Identifiers
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2014-A01201-46
Identifier Type: OTHER
Identifier Source: secondary_id
9373
Identifier Type: -
Identifier Source: org_study_id
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