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

Research output: Contribution to journalArticle

10 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)611-619
Number of pages9
JournalContemporary Clinical Trials
Volume33
Issue number4
DOIs
Publication statusPublished - 2012 Jul 1

Fingerprint

Healthy Volunteers
Clinical Trials
Surveys and Questionnaires
Therapeutic Equivalency
Republic of Korea
Ambulatory Care Facilities
Decision Making
Hospitalization
Research Personnel
Physicians

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

Chu, Sang Hui ; Jeong, Seok Hee ; Kim, Eun Jung ; Park, Min Soo ; Park, Kyungsoo ; Nam, Moonsuk ; Shim, Jae Yong ; Yoon, Young Ran. / The views of patients and healthy volunteers on participation in clinical trials : An exploratory survey study. In: Contemporary Clinical Trials. 2012 ; Vol. 33, No. 4. pp. 611-619.
@article{49b4110a2fe34d4c8e116c500d369e87,
title = "The views of patients and healthy volunteers on participation in clinical trials: An exploratory survey study",
abstract = "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.",
author = "Chu, {Sang Hui} and Jeong, {Seok Hee} and Kim, {Eun Jung} and Park, {Min Soo} and Kyungsoo Park and Moonsuk Nam and Shim, {Jae Yong} and Yoon, {Young Ran}",
year = "2012",
month = "7",
day = "1",
doi = "10.1016/j.cct.2012.02.018",
language = "English",
volume = "33",
pages = "611--619",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "4",

}

The views of patients and healthy volunteers on participation in clinical trials : An exploratory survey study. / Chu, Sang Hui; Jeong, Seok Hee; Kim, Eun Jung; Park, Min Soo; Park, Kyungsoo; Nam, Moonsuk; Shim, Jae Yong; Yoon, Young Ran.

In: Contemporary Clinical Trials, Vol. 33, No. 4, 01.07.2012, p. 611-619.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The views of patients and healthy volunteers on participation in clinical trials

T2 - An exploratory survey study

AU - Chu, Sang Hui

AU - Jeong, Seok Hee

AU - Kim, Eun Jung

AU - Park, Min Soo

AU - Park, Kyungsoo

AU - Nam, Moonsuk

AU - Shim, Jae Yong

AU - Yoon, Young Ran

PY - 2012/7/1

Y1 - 2012/7/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84861531182&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84861531182&partnerID=8YFLogxK

U2 - 10.1016/j.cct.2012.02.018

DO - 10.1016/j.cct.2012.02.018

M3 - Article

C2 - 22405971

AN - SCOPUS:84861531182

VL - 33

SP - 611

EP - 619

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 4

ER -