Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition)and their series interpretation(4):sources of research question and study protocol development in pharmacoepidemiological research
10.12173/j.issn.1005-0698.202504010
- VernacularTitle:《中国药物流行病学研究方法学指南(第2版)》及其系列解读(4):药物流行病学研究的问题来源与方案制定
- Author:
Yinchu CHENG
1
;
Na HE
;
Yingying YAN
;
Siyan ZHAN
;
Feng SUN
Author Information
1. 北京大学第三医院药学部(北京 100191);北京大学医学部药物评价中心(北京 100191);美国哈佛大学医学院与哈佛朝圣者医疗保健研究所人群医学系(美国波士顿02215)
- Publication Type:Journal Article
- Keywords:
Pharmacoepidemiology;
Methodology;
Guidelines;
Research question;
Study protocol
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(4):365-372
- CountryChina
- Language:Chinese
-
Abstract:
Formulating a well-defined research question and developing a scientifically sound study protocol is important for ensuring the quality of pharmacoepidemiological research.Based on the Guide on Methodological Standards in Pharmacoepidemiology in China(2nd edition),this research provided an interpretation of the sections related to the formulation of research questions and the development of study protocols.First,it clarified the sources and scope of research questions,outlining a two-step approach—question generation and definition—and introduces relevant evaluation tools and defining frameworks.Furthermore,it systematically explained the key elements of a study protocol and provides an in-depth explanation of the research methodology and its critical aspects.Finally,the paper highlighted the importance of feasibility assessment,emphasizing that the process of defining research questions and study protocols is dynamic and iterative.Compared with the previous edition,the 2nd edition of the guidelines offers more detailed and updated guidance on question formulation and protocol development.It added three new elements—such as protocol archiving or registration—and three new content items,including study objectives.The 2nd edition also expanded the methodological framework and strengthens feasibility assessments,thereby enhancing the comprehensiveness and rigor of its practical guidance.By integrating guideline content with practical experience,this paper provided insights into its implications for pharmacoepidemiological research and serves as a reference for researchers in the field.
