Ethical issues and countermeasures of early phase trials
10.12092/j.issn.1009-2501.2021.07.012
- Author:
Chenxi OUYANG
1
;
Jie HUANG
2
;
Yuxia XIANG
2
;
Xiaomin WANG
2
;
Jie HUANG
3
;
Yuxia XIANG
3
;
Xiaomin WANG
3
;
Xiaomin WANG
4
Author Information
1. School of Pharmacy, Hunan Univeristy of Chinese Medicine
2. Research Center for Clinical Trial, Center of Clinical Pharmacology, the Third Xiangya Hospital Central South University
3. Central South University National and Local Joint Engineering Laboratory for Drug Clinical Evaluation Technology
4. Center for Medical Ethics, Central South University
- Publication Type:Journal Article
- Keywords:
Countermeasures;
Early clinical trials;
Ethical challenges
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2021;26(7):802-807
- CountryChina
- Language:Chinese
-
Abstract:
Early phase trials refer to the early exploratory stage of transferring drug development into clinical trials. With China's strong encouragement for innovative drug research and development and enterprises vigorous investment, a large number of innovative drugs have entered early clinical trials. Early phase trials are generally based on innovative diagnosis and treatment mechanisms, pharmaceutical technology and drug delivery methods. Their research design are complex and diverse, and the new technology such as computer simulation are also widely used in the early phase trial process. These aspects are major challenges for the scientific and ethical review of early phase trials. Based on the characteristics of early phase trials, this article analyzes the ethical issues in early clinical trials such as risk uncertainty, therapeutic misunderstanding, subject compensation, breakthrough treatment, etc., and puts forward ethical countermeasures and suggestions.
