New perspectives on the principle of intention to treat in clinical trials

Lihong Huang; Zhaohui Wei; Ling Wang; Jielai Xia; Fangrong Yan; Yang Zhao; Feng Chen; Lihong Huang; Ling Wang; Fangrong Yan; Zhaohui Wei; Yang Zhao

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New perspectives on the principle of intention to treat in clinical trials

Author: Lihong HUANG ¹ ; Zhaohui WEI ² ; Ling WANG ³ ; Jielai XIA ³ ; Fangrong YAN ⁴ ; Yang ZHAO ⁵ ; Feng CHEN ⁵ ; Lihong HUANG ⁶ ; Ling WANG ⁶ ; Fangrong YAN ⁶ ; Zhaohui WEI ⁶ ; Yang ZHAO ⁶
Author Information

1. Department of Biostatistics, Zhongshan Hospital, Fudan University
2. Department of Biostatistics, Tiger Medical Company
3. Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University
4. Department of Biostatistics, China Pharmaceutical University
5. Department of Biostatistics, School of Public Health, Nanjing Medical University
6. RWS Panel of Expert Committee on Biostatistics of CSCO
Publication Type:Journal Article
Keywords: Clinical trial; Intended to treat; Real world study; Single-arm trial
From: Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(4):449-453
CountryChina
Language:Chinese
Abstract: The intention to treat (ITT) principle is widely applied in the randomized controlled trials (RCTs), which is based on the intention to treat a subject (i.e. the planned treatment regimen) rather than the actual treatment given. With the development and progress of clinical trials, ITT principle needs to be reinterpreted. In the standard definition of ITT principle, the intentional grouping of subjects does not specifically refer to randomization, but rather to planned treatment regimen. In non-randomized clinical trials, that subjects agree to be included in a certain treatment regimen is also a type of intention. ITT principles can be applied to evaluate the effectiveness of treatment regimens under patient/doctor determined intentionality in single-arm clinical trials and non-randomized RWS (real world study, RWS). In the practical application, the grouping strategy based on ITT principle should be considered comprehensively according to the research purpose.