Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Zhuoran Kuang,Jianxiong Cai,Yaolong Chen,Xiaoyuan Qiu,Xiaoyan Li,Xiaojia Ni

doi:10.1186/s13063-021-05113-y

Zhuoran Kuang, Jianxiong Cai + Show 4 more

Open Access

https://doi.org/10.1186/s13063-021-05113-y

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Abstract

ObjectiveTo assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS.MethodWe searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes.ResultsA total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s).ConclusionOverall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

Highlights

Clinical trial registration is the process of registering critical information on medical research in publicly accessible databases to allow transparency and facilitate the design and implementation of a myriad of clinical trials [1, 2]
Our study identified 90 traditional Chinese medicine (TCM) Clinical trial (CT) entries for COVID-19 and 7 for H1N1 influenza (H1N1)
Data from previous studies found 39% of clinical trials identified as retrospective [13]; our study found that the registrations of traditional Chinese medicine clinical trials (TCM CTs) conducted during two infectious disease outbreaks were almost all prospective (100% in H1N1 and 87% in COVID-19)

Summary

Introduction

Clinical trial registration is the process of registering critical information on medical research in publicly accessible databases to allow transparency and facilitate the design and implementation of a myriad of clinical trials [1, 2]. In 2004, a plan for implementing a global registry of clinical trials under the name of the International Clinical Trial Registration Platform (ICTRP) by the World Health Organization (WHO) emerged. In China, one of the primary registers of ICTRP, the Chinese Clinical Trial Registry (ChiCTR), was established in 2006 and given responsibility for submitting registered records to ICTRP [3]. Recent years have witnessed the following progress in the registration of clinical trials in China. Registration in the Chinese Clinical Trial Registry is a necessary component in the application to conduct medical research projects. As of March 14, 2016, the ChiCTR has required registrants to include information on individual participant data (IPD) management and sharing plans [4]

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