Interpretation of the methodological framework of clinical research on innovative medical devices
- VernacularTitle:创新医疗器械临床研究方法学框架解读
- Author:
Qiong GUO
1
;
Kun FENG
2
;
Youlin LONG
3
,
4
;
Yifei LIN
3
,
5
;
Jin XIANG
6
;
Jin HUANG
3
,
4
;
Liang DU
3
,
4
,
7
Author Information
1. Medical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
3. 1. Medical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
4. 2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
5. 3. Precision Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
6. Clinical Trials Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
7. 5. Department of Periodical Press, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
- Publication Type:Journal Article
- Keywords:
Medical device;
IDEAL framework and recommendation;
IDEAL-D framework;
clinical research;
methodological framework
- From:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
2022;29(07):828-833
- CountryChina
- Language:Chinese
-
Abstract:
The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.
