Implications of the lack of a unified research project framework: an investigation into the registration of clinical trials of COVID-19
| العنوان: | Implications of the lack of a unified research project framework: an investigation into the registration of clinical trials of COVID-19 |
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| المؤلفون: | Chen Yao, Junkai Lai, Feifei Jin, Bin Wang, Xiaoyan Yan |
| المصدر: | Current Medical Research and Opinion |
| بيانات النشر: | Informa UK Limited, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Research design, medicine.medical_specialty, Randomization, Coronavirus disease 2019 (COVID-19), Pneumonia, Viral, Traditional Chinese medicine, Disease, 030204 cardiovascular system & hematology, Betacoronavirus, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, 030212 general & internal medicine, Pandemics, Clinical Trials as Topic, SARS-CoV-2, business.industry, COVID-19, General Medicine, Clinical trial, Research Design, Sample size determination, Emergency medicine, Observational study, Coronavirus Infections, business |
| الوصف: | Objective: The aim of this study was to provide recommendations for improving the design of subsequent studies through analysis of the registered coronavirus disease 2019 (COVID-19) clinical trials.Methods: A retrospective analysis of 189 trial retrievals achieved on 20 February 2020.Results: A total of 189 trials are included in the study. There were 69.3% interventional studies, 21.7% observational studies, 5.3% diagnostic tests and 3.7% other studies. The following statistics are provided only for the interventional studies. Severity of disease: 5.3% light and common type, 17.6% severe and critically ill and 59.6% with no restricted classification. Medication use: 51.1% Western medicine, 32.1% Chinese medicine, 10.7% blood related product and 6.1% non-drug therapy. The median and inner quantile range of the sample sizes included in these studies: 104 (IQR: 60, 200). Primary outcome type most used: 45.8% with clinical characteristics and 21.4% with virological. Study design characteristics: 71% of all studies were randomized, 5% of all studies were blinded, 18% of all studies were multicenter and 76% of all studies were single center.Conclusion: Although many COVID-19 studies include randomization in their design, the lack of additional double-blind and placebo-controlled elements in their designs result in a less robust evaluation of intervention safety and efficacy. Furthermore, similar or repeated research and small sample studies that have less promise in gains of new information have possibly led to a shortage of recruitable patients and become a barrier to the completion of large multicenter clinical trial studies. |
| اللغة: | English |
| تدمد: | 1473-4877 0300-7995 |
| DOI: | 10.1080/03007995.2020.1771294 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::044df2e730aec0ccfd17267276189cfd |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....044df2e730aec0ccfd17267276189cfd |
| قاعدة البيانات: | OpenAIRE |
PDF full text from Publisher | تدمد: | 14734877 03007995 |
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| DOI: | 10.1080/03007995.2020.1771294 |