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

详细信息	查看全文 | 推荐本文 |

• 作者：Sang Hui Chu^a ; Seok Hee Jeong^b ; Eun Jung Kim^c ; ^{ejerkim@eulji.ac.kr} ; Min Soo Park^d ; Kyungsoo Park^e ; Moonsuk Nam^f ; Jae Yong Shim^g ; Young-Ran Yoon^h
• 关键词：CT ; clinical trials ; CRNs ; clinical research nurses ; SDs ; standard deviations
• 刊名：Contemporary Clinical Trials
• 出版年：2012
• 期刊代码：63_15517144
• 类别：med
• 出版时间：July, 2012
• 卷：33
• 期：4
• 页码：611-619
• 文件大小：902 K

摘要

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.