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新型冠状病毒肺炎与临床试验:当前挑战与未来方向。

COVID-19 and Clinical Trials: Current Challenges and Future Directions.

机构信息

Department of Medicine, Maulana Azad Medical College, New Delhi, India.

Department of Laboratory Diagnostics, Medical University of Lublin, Lublin, Poland.

出版信息

Rev Recent Clin Trials. 2021;16(3):258-261. doi: 10.2174/1574887116666210122160705.

DOI:10.2174/1574887116666210122160705
PMID:33480349
Abstract

BACKGROUND

The outbreak of coronavirus disease (COVID-19) has posed a major threat to people's lives across the globe. It has drastically changed the way we perceive this world. A paradigm shift was observed globally as the world's emphasis shifted to testing, diagnosis, treatment, and developing a coronavirus cure. Clinical trials were also not untouched by this. The coronavirus pandemic has abhorrently affected the day-to-day clinical trial activities at sites.

METHODS

The status of various ongoing clinical trials was assessed through a literature search, which also includes clinical trial portals. Our evaluations were based on these observations.

RESULTS

Multiple challenges were present in clinical trials as recruitment, retention, the safety of trial subjects, protocol compliance, and this made the world to re-think to incorporate newer strategies and to cope with this untoward situation.

CONCLUSION

Digitalization of clinical trials as virtual management of adverse events, remote monitoring visits, and web-based consulting with trial subjects are potential directions that can be applied to better manage clinical trials worldwide.

摘要

背景

冠状病毒病(COVID-19)的爆发对全球人民的生命构成了重大威胁。它极大地改变了我们对世界的看法。随着全球重点转向检测、诊断、治疗和开发冠状病毒疗法,人们观察到了一种范式转变。临床试验也受到了这一影响。冠状病毒大流行可恶地影响了各个地点的日常临床试验活动。

方法

通过文献检索,包括临床试验门户,评估了各种正在进行的临床试验的现状。我们的评估基于这些观察结果。

结果

临床试验中存在多种挑战,如招募、保留、试验对象的安全、遵守方案等,这使得世界重新思考采用新策略来应对这种意外情况。

结论

临床试验的数字化,如虚拟管理不良事件、远程监测访问和基于网络的与试验对象咨询,是可以应用于更好地管理全球临床试验的潜在方向。

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