Certara is launching the COVID-19 Clinical Outcomes Database, funded by the COVID-19 Therapeutics Accelerator. The Database includes observational studies and clinical trials with more than 10 patients that evaluate specific treatment options to improve disease outcome. It captures all patient characteristics, safety and efficacy outcomes, biomarkers and viral load data. The database also includes studies (>100 patients) that evaluate patient characteristics stratified by disease outcome such as death, or progression to severe or critical disease and studies (>10 patients) that report the time course of viral load, vital signs, and biomarkers.
The COVID-19 pandemic has turned our lives upside down and so many questions remain, including around how it is affecting health technology assessment (HTA) bodies. HTA bodies report that they have had to ramp up and are increasingly relying on smaller evidence sets. Going forward the priorities for and speed of assessments, particularly for vaccines, is likely to increase. On top of this, economies struggling with significantly increased levels of debt may respond by tightening budgets outside communicable diseases thus affecting assessment priorities, methods and recommendations.
Modeling and simulation were used to optimize a sponsor’s Phase 3 clinical trial study design to achieve efficacy and safety goals as well as regulatory approval.
This blog asks and answers 10 critical drug development questions whether you have a new molecular entity or are repurposing a drug already in clinical use.
Henri Merdjan explains why topical drug formulations (e.g. intranasal and/or oral) could be valuable as a therapeutic option for COVID-19 patients.
Clinical pharmacology provides a valuable opportunity to accelerate the near-term development of existing repurposed drugs for COVID-19 treatment and therapy.
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Innovative contracts are helpful in navigating an evolving pharma marketplace while providing new approaches to distributing life-saving treatments to patients.
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PBPK modeling using a virtual oncology population can help to predict exposure and accelerate the development of safe and efficacious oncology drugs.