The importance of appropriate selection of clinical endpoints in outpatient COVID-19 clinical trials

被引:4
|
作者
Thorlund, Kristian [1 ]
Smith, Davey [2 ]
Linsell, Christopher [3 ]
White, Nicholas [4 ]
Butler, Christopher [5 ]
Boulware, David [6 ]
Currier, Judith [7 ]
Harari, Ofir [8 ]
Lhomme, Edouard [9 ]
Strub-Wourgaft, Nathalie [10 ]
Adam, Stacey [11 ]
Mills, Edward [1 ]
机构
[1] McMaster Univ, Hamilton, ON, Canada
[2] Univ Calif San Diego, Sch Hlth Sci, San Diego, CA USA
[3] Vanderbilt Univ, Vanderbilt Inst Clin & Translat Res VICTR Methods, Nashville, TN USA
[4] Univ Oxford, Ctr Trop Med & Global Hlth, Nuffield Dept Med, Oxford, England
[5] Univ Oxford, Nuffield Dept Primary Care Hlth Sci, Oxford, England
[6] Univ Minnesota, Med Sch, Minneapolis, MN USA
[7] Univ Calif Los Angeles, Dept Med, UCLA Div Infect Dis, Los Angeles, CA USA
[8] Cytel, Vancouver, BC, Canada
[9] Hosp Ctr Univ Bordeaux, Bordeaux, France
[10] Drugs Neglected Dis Initiat, Geneva, Switzerland
[11] Fdn Natl Inst Hlth, North Bethesda, MD USA
来源
COMMUNICATIONS MEDICINE | 2023年 / 3卷 / 01期
关键词
PEOPLE;
D O I
10.1038/s43856-023-00281-1
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Clinical trial endpoints must be carefully and intentionally selected so that the results of the trial can be used to inform policy- and decision-making. The relative importance of potential endpoints often depends on the stakeholder, with patients having different preferences to policymakers and regulators. The set up of clinical trials for COVID-19 was problematic, as endpoints that could be reasonably measured did not always match the efficacy endpoints usually required by guideline panels. Thus, different endpoints were used, which made the timely comparison and evaluation of interventions difficult. Here we discuss the evolution of the COVID-19 landscape and the effect this is having on the selection of consistent and measurable clinical trial endpoints. Using appropriate endpoints is crucial for researchers to offer the most reliable, valid, and interpretable results possible. Thorlund et al. discuss considerations when selecting appropriate endpoints for outpatient COVID-19 clinical trials. Improvements in patient outcomes during the COVID-19 pandemic have necessitated changes to the outcomes being assessed.
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页数:5
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