Current Status and Challenges of Biological Sample Management in Clinical Trials
10.12026/j.issn.1001-8565.2023.06.03
- VernacularTitle:临床试验生物样本管理的现状与挑战
- Author:
Rui PAN
1
;
Xianglin ZUO
2
;
Xiaolin LIU
3
;
Jie WANG
2
;
Xiuqin WANG
4
;
Xu HUANG
5
;
Lili SHA
6
;
Niu ZHANG
7
;
Li WAN
8
;
Jun BAO
3
Author Information
1. Department of Planning and Information, Jiangsu Commission of Health, Nanjing 210009, China
2. Department of Tumor Biobank, Jiangsu Cancer Hospital, Nanjing 210009, China
3. Ethics Committee, Jiangsu Cancer Hospital, Nanjing 210009, China
4. International Cooperation Department, the First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, China
5. Legal Affairs Office, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
6. Department of Science & Technology, Nanjing Drum Tower Hospital, Nanjing 210008, China
7. Ethics Committee, Affiliated Hospital of Nantong University, Nantong 226001, China
8. Medical Ethics Branch, Jiangsu Medical Association, Nanjing 210023, China
- Publication Type:Journal Article
- Keywords:
Biological Sample;
Ethical Management;
Clinical Trial;
Laws and Regulations;
SampleManagement
- From:
Chinese Medical Ethics
2023;36(6):606-612
- CountryChina
- Language:Chinese
-
Abstract:
With the rapid development of clinical trials, the relevant medical research and molecular detection based on biological samples are closely related to the progress of clinical trials, making the role of biological samples in clinical trials increasingly obvious. The standardized supervision mode of biological samples is an important prerequisite for carrying out high-quality clinical trials. Although the laws and regulations related to clinical trials are becoming more and more perfect, there are still a large number of adverse events related to biological samples, which seriously affects the progress and results of clinical trials, and is one of the important challenges currently facing. Therefore, it is urgent to enhance the supervision of biological samples and improve the management methods of biological samples in clinical trials at this stage. Through in-depth discussion of the current status of biological sample management in clinical trials at home and abroad, this paper analyzed the issues existed during the supervision of biological samples, and supplemented the biological sample management methods by further combing the existing relevant laws and regulations and the Guidelines for the Ethical Management of Biological Samples in Clinical Trials, with a view to providing suggestions and ideas for optimizing the management mode of biological samples in clinical trials.
