Criteria Associated With Patient Willingness to Participate in Biomedical Research

NCT ID: NCT03098303

Last Updated: 2020-08-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-23

Study Completion Date

2016-12-13

Brief Summary

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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

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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.

Conditions

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Consulting in Pneumology Department, But Not for Oncology or Tobacology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Clinique de Marignane

Marignane, , France

Site Status

APHM - Hôpital Nord

Marseille, , France

Site Status

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

Site Status

Countries

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France

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.

Reference Type RESULT
PMID: 32791969 (View on PubMed)

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.

Reference Type RESULT
PMID: 30922104 (View on PubMed)

Related Links

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https://osf.io/gccjd/

The PROTOACCEPT patient questionnaire

https://osf.io/nsjjr/

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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