Bacchieri Antonella, Rossi Andrea, Morelli Paolo
CROS-NT, Verona, Italy.
Medical Writing, Communications, and Scientific Affairs, Rte de St Cergue, 6, 1260, Nyon, CH, Switzerland.
Contemp Clin Trials Commun. 2020 Dec;20:100682. doi: 10.1016/j.conctc.2020.100682. Epub 2020 Nov 30.
The COVID-19 virus diffusion is, nowadays, global and any clinical trial is potentially affected by the direct and indirect consequences of the COVID-19 during the pandemic. Any step, from protocol design to result's disclosure, needs to be revised to assess the impact of the COVID-19 on the study, evaluate the potential risks, and establish a mitigation plan. We have developed a series of recommendations, belonging to our experience in any aspect of clinical trials. We hope that the Risk and Mitigation actions for clinical trials during COVID-19 Pandemic (RiMiCOPa) will help all clinical trial professionals, patients, auditors, and assessors to ensure effective data management, statistics, and medical writing standards while conducting clinical trials in the pandemic.
如今，新冠病毒的传播是全球性的，在疫情期间，任何临床试验都可能受到新冠疫情直接和间接后果的影响。从方案设计到结果披露的每一个环节，都需要进行修订，以评估新冠疫情对研究的影响，评估潜在风险，并制定缓解计划。我们根据自身在临床试验各方面的经验，制定了一系列建议。我们希望《新冠疫情期间临床试验的风险与缓解措施（RiMiCOPa）》能帮助所有临床试验专业人员、患者、审计人员和评估人员在疫情期间进行临床试验时确保有效的数据管理、统计和医学写作标准。
