Clinical Endpoints for Evaluating Efficacy in COVID-19 Vaccine Trials.
Ann Intern Med
; 174(2): 221-228, 2021 02.
Article
in English
| MEDLINE | ID: covidwho-890662
ABSTRACT
Several vaccine candidates to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or coronavirus disease 2019 (COVID-19) have entered or will soon enter large-scale, phase 3, placebo-controlled randomized clinical trials. To facilitate harmonized evaluation and comparison of the efficacy of these vaccines, a general set of clinical endpoints is proposed, along with considerations to guide the selection of the primary endpoints on the basis of clinical and statistical reasoning. The plausibility that vaccine protection against symptomatic COVID-19 could be accompanied by a shift toward more SARS-CoV-2 infections that are asymptomatic is highlighted, as well as the potential implications of such a shift.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Randomized Controlled Trials as Topic
/
COVID-19 Vaccines
/
COVID-19
Type of study:
Diagnostic study
/
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
Ann Intern Med
Year:
2021
Document Type:
Article
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