Deficiencies in Planning Interventional Trial Registration of COVID-19 in China

Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registra...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Xiaodan Li [verfasserIn] Shengzhao Zhang [verfasserIn] Yiling Zhou [verfasserIn] Ying Liu [verfasserIn] Youlian Zhou [verfasserIn] Sheyu Li [verfasserIn] Na Su [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2021

Schlagwörter:	COVID-19 SARS-CoV-2 interventional trials registries China sample size index

Übergeordnetes Werk:	In: Frontiers in Medicine - Frontiers Media S.A., 2014, 8(2021)
Übergeordnetes Werk:	volume:8 ; year:2021

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.3389/fmed.2021.618185

Katalog-ID:	DOAJ072313056

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520			\|a Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence.
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allfields	10.3389/fmed.2021.618185 doi (DE-627)DOAJ072313056 (DE-599)DOAJ9ffca6ffb44f4fc88a4aa862237d5178 DE-627 ger DE-627 rakwb eng R5-920 Xiaodan Li verfasserin aut Deficiencies in Planning Interventional Trial Registration of COVID-19 in China 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence. COVID-19 SARS-CoV-2 interventional trials registries China sample size index Medicine (General) Shengzhao Zhang verfasserin aut Shengzhao Zhang verfasserin aut Yiling Zhou verfasserin aut Ying Liu verfasserin aut Youlian Zhou verfasserin aut Sheyu Li verfasserin aut Sheyu Li verfasserin aut Na Su verfasserin aut Na Su verfasserin aut In Frontiers in Medicine Frontiers Media S.A., 2014 8(2021) (DE-627)789482991 (DE-600)2775999-4 2296858X nnns volume:8 year:2021 https://doi.org/10.3389/fmed.2021.618185 kostenfrei https://doaj.org/article/9ffca6ffb44f4fc88a4aa862237d5178 kostenfrei https://www.frontiersin.org/articles/10.3389/fmed.2021.618185/full kostenfrei https://doaj.org/toc/2296-858X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2021
spelling	10.3389/fmed.2021.618185 doi (DE-627)DOAJ072313056 (DE-599)DOAJ9ffca6ffb44f4fc88a4aa862237d5178 DE-627 ger DE-627 rakwb eng R5-920 Xiaodan Li verfasserin aut Deficiencies in Planning Interventional Trial Registration of COVID-19 in China 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence. COVID-19 SARS-CoV-2 interventional trials registries China sample size index Medicine (General) Shengzhao Zhang verfasserin aut Shengzhao Zhang verfasserin aut Yiling Zhou verfasserin aut Ying Liu verfasserin aut Youlian Zhou verfasserin aut Sheyu Li verfasserin aut Sheyu Li verfasserin aut Na Su verfasserin aut Na Su verfasserin aut In Frontiers in Medicine Frontiers Media S.A., 2014 8(2021) (DE-627)789482991 (DE-600)2775999-4 2296858X nnns volume:8 year:2021 https://doi.org/10.3389/fmed.2021.618185 kostenfrei https://doaj.org/article/9ffca6ffb44f4fc88a4aa862237d5178 kostenfrei https://www.frontiersin.org/articles/10.3389/fmed.2021.618185/full kostenfrei https://doaj.org/toc/2296-858X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2021
allfields_unstemmed	10.3389/fmed.2021.618185 doi (DE-627)DOAJ072313056 (DE-599)DOAJ9ffca6ffb44f4fc88a4aa862237d5178 DE-627 ger DE-627 rakwb eng R5-920 Xiaodan Li verfasserin aut Deficiencies in Planning Interventional Trial Registration of COVID-19 in China 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence. COVID-19 SARS-CoV-2 interventional trials registries China sample size index Medicine (General) Shengzhao Zhang verfasserin aut Shengzhao Zhang verfasserin aut Yiling Zhou verfasserin aut Ying Liu verfasserin aut Youlian Zhou verfasserin aut Sheyu Li verfasserin aut Sheyu Li verfasserin aut Na Su verfasserin aut Na Su verfasserin aut In Frontiers in Medicine Frontiers Media S.A., 2014 8(2021) (DE-627)789482991 (DE-600)2775999-4 2296858X nnns volume:8 year:2021 https://doi.org/10.3389/fmed.2021.618185 kostenfrei https://doaj.org/article/9ffca6ffb44f4fc88a4aa862237d5178 kostenfrei https://www.frontiersin.org/articles/10.3389/fmed.2021.618185/full kostenfrei https://doaj.org/toc/2296-858X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2021
allfieldsGer	10.3389/fmed.2021.618185 doi (DE-627)DOAJ072313056 (DE-599)DOAJ9ffca6ffb44f4fc88a4aa862237d5178 DE-627 ger DE-627 rakwb eng R5-920 Xiaodan Li verfasserin aut Deficiencies in Planning Interventional Trial Registration of COVID-19 in China 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence. COVID-19 SARS-CoV-2 interventional trials registries China sample size index Medicine (General) Shengzhao Zhang verfasserin aut Shengzhao Zhang verfasserin aut Yiling Zhou verfasserin aut Ying Liu verfasserin aut Youlian Zhou verfasserin aut Sheyu Li verfasserin aut Sheyu Li verfasserin aut Na Su verfasserin aut Na Su verfasserin aut In Frontiers in Medicine Frontiers Media S.A., 2014 8(2021) (DE-627)789482991 (DE-600)2775999-4 2296858X nnns volume:8 year:2021 https://doi.org/10.3389/fmed.2021.618185 kostenfrei https://doaj.org/article/9ffca6ffb44f4fc88a4aa862237d5178 kostenfrei https://www.frontiersin.org/articles/10.3389/fmed.2021.618185/full kostenfrei https://doaj.org/toc/2296-858X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2021
allfieldsSound	10.3389/fmed.2021.618185 doi (DE-627)DOAJ072313056 (DE-599)DOAJ9ffca6ffb44f4fc88a4aa862237d5178 DE-627 ger DE-627 rakwb eng R5-920 Xiaodan Li verfasserin aut Deficiencies in Planning Interventional Trial Registration of COVID-19 in China 2021 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence. COVID-19 SARS-CoV-2 interventional trials registries China sample size index Medicine (General) Shengzhao Zhang verfasserin aut Shengzhao Zhang verfasserin aut Yiling Zhou verfasserin aut Ying Liu verfasserin aut Youlian Zhou verfasserin aut Sheyu Li verfasserin aut Sheyu Li verfasserin aut Na Su verfasserin aut Na Su verfasserin aut In Frontiers in Medicine Frontiers Media S.A., 2014 8(2021) (DE-627)789482991 (DE-600)2775999-4 2296858X nnns volume:8 year:2021 https://doi.org/10.3389/fmed.2021.618185 kostenfrei https://doaj.org/article/9ffca6ffb44f4fc88a4aa862237d5178 kostenfrei https://www.frontiersin.org/articles/10.3389/fmed.2021.618185/full kostenfrei https://doaj.org/toc/2296-858X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 8 2021
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author	Xiaodan Li
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topic_title	R5-920 Deficiencies in Planning Interventional Trial Registration of COVID-19 in China COVID-19 SARS-CoV-2 interventional trials registries China sample size index
topic	misc R5-920 misc COVID-19 misc SARS-CoV-2 misc interventional trials misc registries misc China misc sample size index misc Medicine (General)
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title	Deficiencies in Planning Interventional Trial Registration of COVID-19 in China
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title_full	Deficiencies in Planning Interventional Trial Registration of COVID-19 in China
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title_sort	deficiencies in planning interventional trial registration of covid-19 in china
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title_auth	Deficiencies in Planning Interventional Trial Registration of COVID-19 in China
abstract	Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence.
abstractGer	Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence.
abstract_unstemmed	Background: The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China.Methods: We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria.Results: A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1.Conclusions: Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence.
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title_short	Deficiencies in Planning Interventional Trial Registration of COVID-19 in China
url	https://doi.org/10.3389/fmed.2021.618185 https://doaj.org/article/9ffca6ffb44f4fc88a4aa862237d5178 https://www.frontiersin.org/articles/10.3389/fmed.2021.618185/full https://doaj.org/toc/2296-858X
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We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. 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Deficiencies in Planning Interventional Trial Registration of COVID-19 in China

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