Research Database to Quantify Impact of Potential COVID-19 Treatments,
with Results from Over 500 Clinical Trials and Observational Studies Over the Next Three Months
PRINCETON, NJ – 2020 年 07 月 23 日 – Certara®, the global leader in biosimulation, announced today that it has launched the COVID-19 Clinical Outcomes Database to provide up-to-date information on the results of COVID-19 clinical trials and observational studies, worldwide. The database captures publicly available study results to quantify and compare the impact of treatments. It is funded by the COVID-19 Therapeutics Accelerator, which was launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, with additional funding from a range of donors.
The COVID-19 Clinical Outcomes Database will help to determine the viability of potential therapeutics and vaccines for COVID-19 by using relevant data from more than 500 registered COVID-19 studies, worldwide, over the next three months. It currently contains results from 68 studies that are testing therapeutics that include chloroquine, hydroxychloroquine, remdesivir, lopinavir/ritonavir, and favipiravir. These studies have been completed and results are available. The database captures all outcome data on safety and efficacy, as well as the impact of risk factors such as age, sex, and co-morbidities. It is curated to address the heterogeneity and variability in datasets across COVID-19 studies.
“Publicly available data from clinical trials are underutilized sources of information that can be used to support drug development decisions,” said Jaap W. Mandema, Ph.D., chief innovation officer at Certara. “The sooner we can predict the probability of a medicine’s success, the sooner we can activate to develop a treatment for COVID-19.”
By pooling data from clinical trials, researchers can conduct model-based meta-analyses and mine insights across studies to gain a holistic understanding of therapeutics being tested to treat COVID-19. Researchers can evaluate risk factors for disease severity and duration. They can also compare efficacy and safety of potential COVID-19 treatments and analyze longitudinal relationships among viral load, vital signs, biomarkers, and outcomes.
The database can be accessed through Certara’s interactive Clinical Outcomes Database Explorer (CODEx) interface, an online platform that enables visualization, exploration, and analysis of data. Registration for CODEx for COVID-19 is available on the COVID-19 Pharmacology Resource Center, an online resource that provides pharmacology simulation tools and a forum for scientific exchange on COVID-19.
The COVID-19 Clinical Outcomes Database is one of over 45 clinical trial outcomes databases developed by Certara across therapeutic areas such as cardiovascular diseases, immunology, and oncology. These clinical trial outcomes databases are used to optimize trial design and dosing and facilitate critical go/no-go decisions at nine of the fifteen leading global pharmaceutical companies. For example, model-based meta-analysis of clinical trial data from 63 studies supported dose selection for a Phase 3 study of a treatment for venous thromboembolism.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 過去6年間に米国 FDA が承認した新薬承認申請の90%以上をサターラのソフトウェアやサービスがサポートしています。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
About the COVID-19 Therapeutics Accelerator
The Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed up the response to the COVID-19 pandemic by identifying, assessing, developing, and scaling up treatments. Its partners are committed to equitable access, including making products available and affordable in low-resource settings. The COVID-19 Therapeutics Accelerator will play a catalytic role by accelerating and evaluating new and repurposed drugs and biologics to treat patients with COVID-19 in the immediate term, and other viral pathogens in the longer term.