The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge
ObjectivesMore than a quarter of single-country systemic lupus erythematosus (SLE) interventional randomized clinical trials (RCTs) were conducted in China. To help develop management guidelines and set benchmarks for future SLE research, a systematic review of current trials is needed.MethodsWe sea...
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| Language: | English |
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Frontiers Media S.A.
2022-04-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2022.848478/full |
| _version_ | 1819062121617424384 |
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| author | Jingru Tian Jingru Tian Jingru Tian Hang Zhou Juan Liu Feng Xiong Ping Yi Pengpeng Cao Dorthy Fang Bo Zhang Qianjin Lu Qianjin Lu Qianjin Lu |
| author_facet | Jingru Tian Jingru Tian Jingru Tian Hang Zhou Juan Liu Feng Xiong Ping Yi Pengpeng Cao Dorthy Fang Bo Zhang Qianjin Lu Qianjin Lu Qianjin Lu |
| author_sort | Jingru Tian |
| collection | DOAJ |
| description | ObjectivesMore than a quarter of single-country systemic lupus erythematosus (SLE) interventional randomized clinical trials (RCTs) were conducted in China. To help develop management guidelines and set benchmarks for future SLE research, a systematic review of current trials is needed.MethodsWe searched systematically three databases and four registries to summarize the interventional RCTs in mainland China and identify factors associated with participant loss. The internal validity of trials was assessed using the Cochrane risk-of-bias tool for assessing risk of bias. The odds ratio (OR) was defined as the ratio of the odds of less than 10% loss to follow-up in the presence or absence of different factors.ResultsA total of 188 trials met our inclusion criteria, and 15·5% of trials conducted in mainland China ranked low risk of bias. Participant loss was significantly higher among trials that had a defined primary outcome or were registered {primary outcome identification (0·02 [0·00-0·23]) and registration (0·14 [0·03-0·69])}. Trials examining traditional Chinese medicine (TCM) pharmacological treatments had an 8·16-fold (8·16 [1·28-51·98]) higher probability of having low participant loss than trials examining non-TCM pharmacological treatment trials, and trials that did not report masking status had a 15·95-fold (15·95 [2·45-103·88]) higher probability of having low participant loss than open-label trials. In addition, published articles in Chinese also had higher probability of having low participant loss (5·39 [1·10-26·37]).ConclusionSLE trials conducted in mainland China were of relatively poor quality. This situation, including nonrigorous design, lack of registration, and absence of compliance reporting, needs to be ameliorated. To maintain the fundamental repeatability and comparability of mainland China SLE RCTs, transparency of the clinical trial process and complete reporting of the trial data are crucial and urgently needed. |
| first_indexed | 2024-12-21T14:53:45Z |
| format | Article |
| id | doaj.art-5f0831fa57144a5c824dcecc09e38d98 |
| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-12-21T14:53:45Z |
| publishDate | 2022-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj.art-5f0831fa57144a5c824dcecc09e38d982022-12-21T18:59:49ZengFrontiers Media S.A.Frontiers in Immunology1664-32242022-04-011310.3389/fimmu.2022.848478848478The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous ChallengeJingru Tian0Jingru Tian1Jingru Tian2Hang Zhou3Juan Liu4Feng Xiong5Ping Yi6Pengpeng Cao7Dorthy Fang8Bo Zhang9Qianjin Lu10Qianjin Lu11Qianjin Lu12Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, ChinaKey Laboratory of Basic and Translational Research on Immune-Mediated Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, ChinaJiangsu Key Laboratory of Molecular Biology for Skin Diseases and Sexually Transmitted Infections, Nanjing, ChinaDepartment of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Dermatology, Hunan Key Laboratory of Medical Epigenomics, The Second Xiangya Hospital, Central South University, Changsha, ChinaDepartment of Molecular, Cellular, and Developmental Biology, Yale University, New Haven, CT, United StatesInstitute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, ChinaInstitute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, ChinaKey Laboratory of Basic and Translational Research on Immune-Mediated Skin Diseases, Chinese Academy of Medical Sciences, Nanjing, ChinaJiangsu Key Laboratory of Molecular Biology for Skin Diseases and Sexually Transmitted Infections, Nanjing, ChinaObjectivesMore than a quarter of single-country systemic lupus erythematosus (SLE) interventional randomized clinical trials (RCTs) were conducted in China. To help develop management guidelines and set benchmarks for future SLE research, a systematic review of current trials is needed.MethodsWe searched systematically three databases and four registries to summarize the interventional RCTs in mainland China and identify factors associated with participant loss. The internal validity of trials was assessed using the Cochrane risk-of-bias tool for assessing risk of bias. The odds ratio (OR) was defined as the ratio of the odds of less than 10% loss to follow-up in the presence or absence of different factors.ResultsA total of 188 trials met our inclusion criteria, and 15·5% of trials conducted in mainland China ranked low risk of bias. Participant loss was significantly higher among trials that had a defined primary outcome or were registered {primary outcome identification (0·02 [0·00-0·23]) and registration (0·14 [0·03-0·69])}. Trials examining traditional Chinese medicine (TCM) pharmacological treatments had an 8·16-fold (8·16 [1·28-51·98]) higher probability of having low participant loss than trials examining non-TCM pharmacological treatment trials, and trials that did not report masking status had a 15·95-fold (15·95 [2·45-103·88]) higher probability of having low participant loss than open-label trials. In addition, published articles in Chinese also had higher probability of having low participant loss (5·39 [1·10-26·37]).ConclusionSLE trials conducted in mainland China were of relatively poor quality. This situation, including nonrigorous design, lack of registration, and absence of compliance reporting, needs to be ameliorated. To maintain the fundamental repeatability and comparability of mainland China SLE RCTs, transparency of the clinical trial process and complete reporting of the trial data are crucial and urgently needed.https://www.frontiersin.org/articles/10.3389/fimmu.2022.848478/fullsystemic lupus erythematosusrandomized clinical trialscross-sectional studyreviewChina |
| spellingShingle | Jingru Tian Jingru Tian Jingru Tian Hang Zhou Juan Liu Feng Xiong Ping Yi Pengpeng Cao Dorthy Fang Bo Zhang Qianjin Lu Qianjin Lu Qianjin Lu The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge Frontiers in Immunology systemic lupus erythematosus randomized clinical trials cross-sectional study review China |
| title | The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge |
| title_full | The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge |
| title_fullStr | The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge |
| title_full_unstemmed | The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge |
| title_short | The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge |
| title_sort | systemic lupus erythematosus interventional trials in mainland china a continuous challenge |
| topic | systemic lupus erythematosus randomized clinical trials cross-sectional study review China |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2022.848478/full |
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