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J Med Life. 2018 Oct-Dec;11(4):320-327. doi: 10.25122/jml-2018-0072.

The Attitude of Patients from a Romanian Tertiary Cardiology Center as Regards Participation in Biomarker-Based Clinical Trials - Survey Methodology.

Author information

1
Department of Cardiology, Clinical Emergency Hospital of Bucharest, Bucharest, Romania.
2
Department of Psychology, "Grigore Alexandrescu" Clinical Hospital of Bucharest, Bucharest, Romania.
3
University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.

Abstract

One of the challenges faced when conducting a clinical trial is the recruitment of the proposed number of participants. Accordingly, identifying barriers to patients' enrollment and developing effective strategies to overcome them is mandatory. One of the main strategies employed to improve participation rate consists of designing the informed consent forms based on patients' feedback. This survey aims to explore the attitude of patients admitted in a Romanian tertiary cardiology center to take part in biomarker-based clinical trials. This is a descriptive, prospective and longitudinal single-center study. Participants will be recruited until the planned sample size will be reached (n=333). The patients will be interviewed based on a semi-structured questionnaire which includes four sections: demographics (7 items), personal medical history (7 items), attitudes (9 items) and trust (4 items). Descriptive statistics will be used to illustrate patients' demographics, medical history, attitudes toward biomarker-based clinical trials and trust in medical researchers. Logistic regression models will be employed to assess relations between patients' attitudes, trust, and different socio-demographic variables. Data analysis will offer answers to key questions addressed by this survey: What amount of and in what form should information be disclosed? Who should make the invitation to participate? The information gained will facilitate tailoring informed consent forms to suit the needs of patients with various demographic, social and educational backgrounds.

KEYWORDS:

Clinical trials (CTs); Informed consent; Informed consent form (ICF); biomarker; clinical trials; methodology; patients’ attitude

PMID:
30894889
PMCID:
PMC6418342
DOI:
10.25122/jml-2018-0072
[Indexed for MEDLINE]
Free PMC Article

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