Clinical trial NCT03098303: Criteria Associated With Patient Willingness to Participate in Biomedical Research
Official title: Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consulting in Pneumology Department, But Not for Oncology or Tobacology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population corresponds to patients with respiratory disease. This study will be proposed to all patients consulting (excluding oncology and tobacco) in the associated departments.

Brief summary: The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).

Detailed description: The secondary objectives of this study are:

* 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.

Eligibility criteria: Inclusion Criteria:

* The patient was informed about the study.
* The patient is scheduled for a consult in the pneumology department

Exclusion Criteria:

* The patient is under judicial protection or is an adult under any kind of guardianship
* 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

Primary outcomes:
measure: Acceptation or refusal to participate in a biomedical research study
timeFrame: Day 0 (cross-sectional study)
Secondary outcomes:
measure: The PROTOACCEPT questionnaire
timeFrame: Day 0 (cross-sectional study)
Other outcomes:
Locations:
city: Boujan-sur-Libron
country: France
facility: Polyclinique Saint-Privat
city: Marignane
country: France
facility: Clinique de Marignane
city: Marseille
country: France
facility: APHM - Hôpital Nord
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
Study officials:
affiliation: Montpellier University Hospitals
name: Arnaud Bourdin, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.