Criteria Associated With Patient Willingness to Participate in Biomedical Research

Consulting in Pneumology Department, But Not for Oncology or Tobacology Clinical Trial

— PROTOACCEPT  

Official title:

Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098303
• Other study ID #: 9373
• Secondary ID: 2014-A01201-46
• Status: Completed
• Start date: December 23, 2014
• Est. completion date: December 13, 2016

Study information

• Verified date: August 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 13, 2016
• Est. primary completion date: December 13, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Consulting in Pneumology Department, But Not for Oncology or Tobacology
• Neoplasms

Locations

Country	Name	City	State
France	Polyclinique Saint-Privat	Boujan-sur-Libron
France	Clinique de Marignane	Marignane
France	APHM - Hôpital Nord	Marseille
France	Centre Hospitalier Universitaire de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptation or refusal to participate in a biomedical research study	Positive or negative response to the question "If a biomedical research protocole were proposed to you, would you accept to participate?"	Day 0 (cross-sectional study)
Secondary	The PROTOACCEPT questionnaire	The PROTOACCEPT questionnaire (see links below).	Day 0 (cross-sectional study)

External Links

•   PROTOACCEPT on the Open Science Framework
•   The PROTOACCEPT patient questionnaire