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Appealing for Efficient, Well Organized Clinical Trials on COVID-19
Yang Zhao; Yongyue Wei; Sipeng Shen; Mingzhi Zhang; Feng Chen.
Afiliación
  • Yang Zhao; Department of Biostatistics, School of Public Health, Nanjing Medical University
  • Yongyue Wei; Department of Biostatistics, School of Public Health, Nanjing Medical University
  • Sipeng Shen; Department of Biostatistics, School of Public Health, Nanjing Medical University
  • Mingzhi Zhang; Department of Biostatistics, School of Public Health, Nanjing Medical University Corresponding Email: fengchen@njmu.edu.cn
  • Feng Chen; Department of Biostatistics, School of Public Health, Nanjing Medical University
Preprint en En | PREPRINT-MEDRXIV | ID: ppmedrxiv-20031476
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ABSTRACT
ABSTRATCThe rapid emergence of clinical trials on COVID-19 stimulated a wave of discussion in scientific community. We reviewed the characteristics of interventional trials from Chinese Clinical Trial Registration (ChiCTR) and ClinicalTrials.gov. A total of 171 COVID-19-related interventional trials were identified on Feb 22nd, 2020. These trials are classified into 4 categories based on treatment modalities, including chemical drugs, biological therapies, traditional Chinese medicine treatments and other therapies. Our analysis focused on the issues of stage, design, randomization, blinding, primary endpoints definition and sample size of these trials. We found some studies with potential defects including unreasonable design, inappropriate primary endpoint definition, insufficient sample size and ethical issue. Clinical trials on COVID-19 should be designed based on scientific rules, ethics and benefits for patients.
Licencia
cc_by_nc
Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Experimental_studies / Prognostic_studies / Rct Idioma: En Año: 2020 Tipo del documento: Preprint
Texto completo: 1 Colección: 09-preprints Base de datos: PREPRINT-MEDRXIV Tipo de estudio: Experimental_studies / Prognostic_studies / Rct Idioma: En Año: 2020 Tipo del documento: Preprint