Issues in and solutions to writing investigator-initiated clinical research protocols from a scientific eval-uation perspective
10.3969/j.issn.1671-332X.2024.02.040
- VernacularTitle:科学性审查视角下研究者发起的临床研究方案撰写问题及对策
- Author:
Jian SUN
1
;
Xuezhi WENG
;
Jiexun ZHANG
Author Information
1. 首都医科大学附属北京安定医院 北京 100088
- Keywords:
Clinical trials;
Scientific review;
Research protocol;
Investigator initiate trials
- From:
Modern Hospital
2024;24(2):311-313,316
- CountryChina
- Language:Chinese
-
Abstract:
The number of investigator initiate trials(IIT)is increasing,and a detailed scientific clinical trial protocol is an important prerequisite for ensuring the success of clinical trials and obtaining reliable and accurate results.In this study,132 scien-tific research projects taken by the researchers of a tertiary hospital were reviewed to summarize and analyze the issues in the re-search designs.It was found the issues in common consisted of five aspects:research background,types of design,inclusion and exclusion criteria,outcomes,and sample size.Meanwhile,the causes of these problems were discussed and the countermeasures were proposed aimed at improving the efficiency of scientific review work and promoting the high-quality operation of IIT projects.
