Real-World Evidence for Assessing Pharmaceutical Treatments in the Context of COVID-19.
Clin Pharmacol Ther
; 109(4): 816-828, 2021 04.
Article
in English
| MEDLINE | ID: covidwho-1059420
ABSTRACT
The emergence and global spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in an urgent need for evidence on medical interventions and outcomes of the resulting disease, coronavirus disease 2019 (COVID-19). Although many randomized controlled trials (RCTs) evaluating treatments and vaccines for COVID-19 are already in progress, the number of clinical questions of interest greatly outpaces the available resources to conduct RCTs. Therefore, there is growing interest in whether nonrandomized real-world evidence (RWE) can be used to supplement RCT evidence and aid in clinical decision making, but concerns about nonrandomized RWE have been highlighted by a proliferation of RWE studies on medications and COVID-19 outcomes with widely varying conclusions. The objective of this paper is to review some clinical questions of interest, potential data types, challenges, and merits of RWE in COVID-19, resulting in recommendations for nonrandomized RWE designs and analyses based on established RWE principles.
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Research Design
/
COVID-19 Drug Treatment
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
Clin Pharmacol Ther
Year:
2021
Document Type:
Article
Affiliation country:
Cpt.2185
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