Jiang, Yutong and Huang, Zhifan and Chen, Lei and Cui, Yukang and Zhu, Hong and Shi, Tongjun and Tan, Zaixiang (2022) How Well Informed of Participants in Clinical Trials: A Case Study of China. International Journal of Clinical Medicine, 13 (04). pp. 167-179. ISSN 2158-284X
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Abstract
Background: With the development of globalization, the rising cost of clinical trials in Europe and the United States, and the huge drug consumption market in developing countries, multinational pharmaceutical giants have set their sights on emerging developing countries. As a leader in developing countries, China has unparalleled advantages, so more and more clinical trials are registered and carried out in China. Objective: The objective of the study is to understand the current practice of informed consent in clinical trials in public hospitals in Xuzhou. Methods: In this study, a 15-question questionnaire was distributed to 369 subjects in the affiliated hospital of Xuzhou medical university. Each question was graded on a 3-point scale (1 = no, 2 = unsure, 3 = yes). The sum of the scores for the 15 questions represented the level of awareness of clinical trials. Results: Valid questionnaires were received from 300 subjects. A considerable number of subjects still had insufficient understanding of clinical trials, especially concerning the nature of clinical trials, understanding of informed consent forms, contact with researchers, and ethics committee. (The “yes” rate was around or below 50%). Factors associated with responses to the survey include education, occupation, and source of medical expenses. Conclusion: Overall, this study showed that the implementation of informed consent in China remained room for improvement. Legislators, ethics officers, and researchers should work together to protect the interests of subjects.
Item Type: | Article |
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Subjects: | Eurolib Press > Medical Science |
Depositing User: | Managing Editor |
Date Deposited: | 15 Mar 2023 09:51 |
Last Modified: | 28 Mar 2024 03:43 |
URI: | http://info.submit4journal.com/id/eprint/802 |