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The views of patients and healthy volunteers on participation in clinical trials: an exploratory survey study.

 Sang Hui Chu  ;  Seok Hee Jeong  ;  Eun Jung Kim  ;  Min Soo Park  ;  Kyungsoo Park  ;  Moonsuk Nam  ;  Jae Yong Shim  ;  Young-Ran Yoon 
 CONTEMPORARY CLINICAL TRIALS, Vol.33(4) : 611-619, 2012 
Journal Title
Issue Date
Adult ; Aged ; Attitude to Health* ; Clinical Trials as Topic/psychology* ; Female ; Health Care Surveys ; Health Knowledge, Attitudes, Practice ; Humans ; Informed Consent ; Male ; Middle Aged ; Patient Participation ; Patient Satisfaction/statistics & numerical data ; Patients/psychology* ; Professional-Patient Relations ; Republic of Korea ; Surveys and Questionnaires ; Volunteers/psychology*
Clinical trials ; Patient ; Healthy subjects ; Views
BACKGROUND AND AIMS: This study was conducted to investigate the views of patients and healthy volunteers on participation in clinical trials.

METHODS: A total of 291 clinical trial participants, including 140 patients and 151 healthy volunteers, were recruited from four university hospital-affiliated clinical trial centers among 15 Korean regional clinical trial centers in South Korea where the levels of information and care were sufficient to meet the global standard. Participants were recruited from phase I trials or bioequivalence tests, a short term hospitalization under close monitoring in the clinical trial centers, or from phase II, III or IV trials occurring in both wards and outpatient clinics. A structured questionnaire survey was performed to identify their perspectives on clinical trials.

RESULTS: Participants who were patients were significantly influenced by medical personnels regarding the decision making processes for participation in clinical trials when compared to healthy volunteers. However, no difference was found between the two groups in the level of willingness to participate in and satisfaction with clinical trials. More than 50% of patient subjects misunderstood and thought that their physicians could persuade them to participate in clinical trials or that all the participants would receive a new drug or treatment during trials.

CONCLUSIONS: Clinical researchers who are involved in clinical trials should make an extra effort to confirm the level of understanding of their patients regarding the clinical trial and to guarantee that each patient has sufficient time to make an informed decision before participating in a clinical trial.
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1. College of Medicine (의과대학) > Dept. of Family Medicine (가정의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실) > 1. Journal Papers
3. College of Nursing (간호대학) > Dept. of Nursing (간호학과) > 1. Journal Papers
Yonsei Authors
Park, Kyungsoo(박경수) ORCID logo https://orcid.org/0000-0002-6972-1143
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
Shim, Jae Yong(심재용) ORCID logo https://orcid.org/0000-0002-9561-9230
Chu, Sang Hui(추상희) ORCID logo https://orcid.org/0000-0001-6877-5599
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