title: The views of patients and healthy volunteers on participation in clinical trials: an exploratory survey study.
abstract: OBJECTIVE
  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.
authors.affiliation: Nursing Policy and Research Institute, Biobehavioral Research Center, Yonsei University College of Nursing, Seoul, Republic of Korea.
authors.forename: Sang Hui
authors.initials: SH
authors.lastname: Chu
authors.forename: Seok Hee
authors.initials: SH
authors.lastname: Jeong
authors.forename: Eun Jung
authors.initials: EJ
authors.lastname: Kim
authors.forename: Min Soo
authors.initials: MS
authors.lastname: Park
authors.forename: Kyungsoo
authors.initials: K
authors.lastname: Park
authors.forename: Moonsuk
authors.initials: M
authors.lastname: Nam
authors.forename: Jae Yong
authors.initials: JY
authors.lastname: Shim
authors.forename: Young-Ran
authors.initials: YR
authors.lastname: Yoon
mesh_terms: D000328:Adult; D000368:Aged; D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000523:psychology*; D005260:Female; D019538:Health Care Surveys; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D010358:Patient Participation; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010361:Patients / Q000523:psychology*; D011369:Professional-Patient Relations; D056910:Republic of Korea; D011795:Surveys and Questionnaires; D014838:Volunteers / Q000523:psychology*