门诊环境临床试验中的住院终点:以抗SARS-COV-2疗法为例
Alhanouf Yousef Alnafisah1, Ahmed Fawaz Alkhalidi1, Hanin Aljohani1
1Efficacy and Safety Evaluation Department, Benefit and Risk Evaluation Directorate, Saudi Food and Drug Authority (SFDA), Riyadh, Saudi Arabia.
住院治疗是门诊COVID-19试验的关键结果,但需要明确的标准,以避免在抗SARS-COV-2治疗评估中的偏见. 标准化这一终点对于可靠的临床试验数据至关重要.
科学领域:
- 临床试验 临床试验
- 传染性疾病 传染性疾病
- 药理学 药理学是指药理学的学科.
背景情况:
- 世界卫生组织 (WHO) 制定了住院COVID-19患者的结果措施.
- 在定义非住院COVID-19患者的结果标准方面存在很大的差距.
研究的目的:
- 讨论住院治疗作为对抗SARS-COV-2疗法的门诊试验的主要结果.
- 确定与使用住院治疗作为这些试验的主要终点相关的潜在陷.
主要方法:
- 一篇关于第三期随机对照试验的叙述性综述.
- 搜索了MEDLINE和临床试验.gov (2020年1月至2022年12月).
- 包括对轻度至中度COVID-19的门诊试验,评估抗SARS-COV-2单克隆抗体或抗病毒剂.
主要成果:
- 确定了12项试验,评估了抗SARS-COV-2疗法.
- 三项研究使用住院和死亡作为单克隆抗体试验的主要终点.
- 九项研究评估了抗病毒药物,其中四项使用住院/死亡,其他研究使用病毒学,症状或临床反应措施.
结论:
- 作为终点的住院治疗可以提供宝贵的成本效益数据.
- 不一致的医院利用率和调查人员的决定可能会导致结果偏差.
- 在临床试验中,明确的标准对于定义影响住院终点的变量至关重要.
更多相关视频
08:36Author Spotlight: Evaluating the Adjuvant Efficacy and Safety of Angong Niuhuang Pill in Viral Encephalitis Treatment
Published on: April 19, 2024
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
相关概念视频
Clinical Trials
There are four phases in a clinical trial. A phase one...
Pulmonary Tuberculosis V
Latent tuberculosis infection occurs when TB bacteria are present in a person's body, but are not causing illness or symptoms. It is not contagious, and preventive treatment is crucial to avoid the...
Hazard Ratio
For example, in a clinical trial...
Pneumonia IV: Management
Bacterial Pneumonia Treatment
For bacterial pneumonia, antibiotics serve as the cornerstone of therapy. Initial treatment often begins with empirical antibiotics, tailored to the anticipated causative organism and adjusted based on culture results. Key antibiotic choices include:
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
