Kêu gọi cải thiện chất lượng trong việc đăng ký thuốc y học cổ truyền trong tình huống khẩn cấp về sức khỏe cộng đồng: một khảo sát về các đăng ký thử nghiệm cho COVID-19, H1N1 và SARS

Tai-xiang WU, You-ping LI, Xun YAO, Jing LI. Clinical trial registration: to improve the quality of clinical research in China. Chin J Evid-based Med. 2006;03:153–6. https://doi.org/10.3969/j.issn.1672-2531.2006.03.001 Chinese. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363–4. https://doi.org/10.1001/jama.292.11.1363. Tai-xiang WU, You-ping LI, Jing LI, Guan-jian LIU. A milestone for clinical trials: the global clinical trial registration system lauched up. Chin J Evid-based Med. 2007;07:479–80. https://doi.org/10.3969/j.issn.1672-2531.2007.07.001 Chinese. Tai-xiang WU, Minawear ABUDU, Yuan HAO, Xiang-yu KONG, Shuo CHEN, You-ping LI. The past 10 years of clinical trial registration in China: status and challenge. Chin J Evid-based Med. 2018;18(06):522–5 Chinese. Emergency regulations for public health emergencies. Available from: http://www.gov.cn/zhengce/zhengceku/2008-03/28/content_6399.htm. [Accessed 30 Apr 2020]. World Health Organization. WHO global report on traditional and complementary medicine 2019. (2019). Available from: https://apps.who.int/iris/handle/10665/312342/(2019). [Accessed 30 Apr 2020]. Hui W, Xin-yao J, Bo P, Chun-xue L, Wen-ke Z, Feng-wen Y, et al. Analysis on clinical study protocols of traditional Chinese medicine for coronavirus disease 2019. China J Chinese Materia Medica. 2020;45(06):1232–41. https://doi.org/10.19540/j.cnki.cjcmm.20200220.501 Chinese. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Ann Intern Med. 2005;143(2):146–8. https://doi.org/10.7326/0003-4819-143-2-200507190-00016. World Health Organization. The Data Providers of the ICTRP Search Portal. Available from: https://www.who.int/ictrp/search/data_providers/en/. [Accessed 30 Apr 2020]. World Health Organization. International standards for clinical trial registries. (2018). Available from: https://apps.who.int/iris/bitstream/handle/10665/274994/9789241514743-eng.pdf?ua=1. [Accessed 30 Apr 2020]. Dai L, Cheng CW, Tian R, Zhong LL, Li YP, Lyu AP, et al. Standard protocol items for clinical trials with traditional Chinese medicine 2018: recommendations, explanation and elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med. 2019;25(1):71–9. https://doi.org/10.1007/s11655-018-2999-x. Cheng CW,Wu TX,Shang HC,et al. CONSORT extension for Chinese herbal medicine formulas 2017: recommendations, explanation, and elaboration (traditional Chinese version)[J]. Ann Internal Med. 2017; 167(2):W7-W20. https://doi.org/10.7326/IsTranslatedFrom_M17-2977_1 Zhang X, Tian R, Yang Z, Zhao C, Yao L, Lau C, et al. Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries. BMJ Open. 2019;9(2):e25218. https://doi.org/10.1136/bmjopen-2018-025218. Gu J, Zhao Y, Wang X, Jiang J, Tian J, Yang K. Registration quality assessment of acupuncture clinical trials. PLoS One. 2013;8(3):e59506. https://doi.org/10.1371/journal.pone.0059506. World Health Organization. WHO trial registration data set (Version 1.3). (2017). Available from: https://www.who.int/ictrp/network/trds_v1.3/en/. [Accessed 30 Apr 2020]. Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS One. 2011;6(2):e14701. https://doi.org/10.1371/journal.pone.0014701. Chinese clinical trial registry. Guideline of registration. Available from: http://www.chictr.org.cn/registry.aspx. [Accessed 30 Apr 2020]. Xiao-zhan Z. The current situation and suggestions on system operation of medical ethics committee in China. Med Jurisprudence. 2016;8(06):28–33. https://doi.org/10.3969/j.issn.1674-7526.2016.06.006 Chinese. Kirchoff MC, Pierson JF. Considerations for use of investigational drugs in public health emergencies. Ther Innov Regul Sci. 2017;51(2):146–52. https://doi.org/10.1177/2168479016680253. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for health-related research involving humans, fourth edition. Geneva: CIOMS; 2016. Treweek S, Juni P, Li T, Collin J, Briel M, Chan AW, et al. COVID-19 randomised trial protocols: rapid publication without barriers. Trials. 2020;21(1):327. https://doi.org/10.1186/s13063-020-04304-3. Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gotzsche PC, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet. 2014;383(9913):257–66. https://doi.org/10.1016/S0140-6736(13)62296-5. Viergever RF, Karam G, Reis A, Ghersi D. The quality of registration of clinical trials: still a problem. PLoS One. 2014;9(1):e84727. https://doi.org/10.1371/journal.pone.0084727. Tse T, Fain KM, Zarin DA. How to avoid common problems when using ClinicalTrials.gov in research: 10 issues to consider. BMJ. 2018;361:k1452. https://doi.org/10.1136/bmj.k1452. Ming Y, Ying Z, Fei D, Ying-ying Z, Yuan-yuan GONG, Yu-tong F, et al. Thoughts on clinical research strategies and methods of Chinese medicine participating treatment of COVID-19. CJITWM. 2020;40(03):283–6 Chinese. Tai-xiang W, Zhao-xiang B, You-ping L, Hong-cai S, Xin-sheng Y. Transparency and sharing individual participant data of clinical trials: a philosophical proposition about the medical study ethics and implications for clinical trials. Chin J Evid-based Med. 2018;18(06):538–42. https://doi.org/10.7507/1672-2531.201803099 Chinese. World Health Organization. Guidance for managing ethical issues guidance for managing ethical issues in infectious disease outbreaks. (2016). Available from: https://apps.who.int/iris/bitstream/handle/10665/250580/9789241549837-eng.pdf?sequence=1. [Accessed 30 Apr 2020]. Moorthy V, Henao RA, Preziosi MP, Swaminathan S. Data sharing for novel coronavirus (COVID-19). Bull World Health Organ. 2020;98(3):150. https://doi.org/10.2471/BLT.20.251561. COVID-19 Knowledge & Data Hub. Available from: http://geodoi.ac.cn/covid-19/DataSearchPaper.aspx. [Accessed 30 Apr 2020]. China releases information on the new coronary pneumonia epidemic and promotes international cooperation on prevention and control of the epidemic. Available from: http://www.xinhuanet.com/politics/2020-04/06/c_1125819214.htm. [Accessed 30 Apr 2020]. The State Council’s Joint Prevention and Control Mechanism for the New Coronavirus Pneumonia Epidemic Scientific Research and Tackling Team on the implementation of the Notice on the Regulation of Medical Institutions to Conduct Clinical Research on New Coronavirus Pneumonia Drug Therapy. Available from: http://www.gov.cn/xinwen/2020-04/08/content_5500215.htm. [Accessed 30 Apr 2020]. Zhang X, Lan L, Chan JCP, Zhong LLD, Cheng CW, Lam WC, et al. WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020: recommendations, explanation, and elaboration. BMC Med Res Methodol. 2020;20(1):192. https://doi.org/10.1186/s12874-020-01077-w.