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Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries
  1. Xuan Zhang1,
  2. Ran Tian1,
  3. Zhen Yang1,
  4. Chen Zhao1,
  5. Liang Yao1,
  6. Chungtai Lau1,
  7. Taixiang Wu2,
  8. Hongcai Shang3,
  9. Xiaoyang Zhang4,
  10. Aiping Lu1,
  11. Zhaoxiang Bian1
  1. 1 Chinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, China
  2. 2 Chinese Cochrane Centre, West China Hospital, Sichuan University, China Trial Registration Center, Chengdu, China
  3. 3 Key Laboratory for Internal Chinese Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
  4. 4 Peking Union Medical College Hospital, China Academy of Medical Sciences, Beijing, China
  1. Correspondence to Professor Zhaoxiang Bian; bianzxiang{at}gmail.com

Abstract

Objective This study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.

Methods The ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.

Results A total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.

Conclusion The registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

  • clinical trial registration
  • traditional Chinese medicine
  • registration quality
  • WHO TRDS
  • WHO ICTRP

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • XiZ and RT are co-first authors.

  • Patient consent for publication Not required.

  • Contributors Conception and design: ZB. Analysis and interpretation of the data: ZB, XZ and RT. Drafting of the article: XZ and ZB. Collection and statistics of data: XZ, RT, ZY, CZ, LY and CL. Critical revision of the manuscript: ZB, TW, HS, XiZ and XZ. Administrative or technical support: AL, TW, HS and XiZ. All authors have read and approved the final manuscript.

  • Funding This work was supported by FunRenHuang Medical Foundation.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement The data used for this study can be freely downloaded from ICTRP search portal at http://apps.who.int/trialsearch/ and from the websites of some of the 17 individual registries. Some data of quality assessment in this study is available from the corresponding author on receiving a reasonable request.

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