Certara Investor Day Presentation Deck
Insights from the COVID-19 CODEX database
Funded by the Bill and Melinda Gates Foundation, now includes 482 COVID-19 trials and real-world studies
Comparison of RCTs and RWSS by COVID Treatment
Overall
Not randomized (n=112)
Randomized (n=77)
Anti-IL-6
Not randomized (n=38)
Randomized (n=14)
Antimalarial
Not randomized (n=26)
Randomized (n=24)
Antiviral
Not randomized (n=12)
Randomized (n=19)
Glucocorticoid
Not randomized (n=28)
Randomized (n=9)
Plasma therapy
Not randomized (n=13)
Randomized (n=14)
0.250
0.500
Odds Ratio of Death
1.000
Real world studies
(RWS)
Randomized
controlled trials
(RCT)
2.000
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Real world studies overestimated COVID treatment
effects compared to randomized controlled trials
Sheds important insights on how to bridge
between real world studies and RCTs
Valuable across all areas from rare diseases
to viral pandemics
CODEX can be used to create synthetic control arms
Growing regulatory support for real-world evidence
FDA U.S. FOOD & DRUG
ADMINISTRATION
FRAMEWORK FOR FDA'S
REAL-WORLD
EVIDENCE
PROGRAM
Real-World Data:
Assessing Registries to
Support Regulatory
Decision-Making for Drug
and Biological Products
Guidance for Industry
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