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Clinical trials of disease stages in COVID 19: complicated and often misinterpreted

As of 2020 年 7 月 28 日, 1840 clinical trials were registered globally, with 1001 clinical trials recruiting patients for COVID-19 management.1 Despite this large number, only 30 trials have been published as peer-reviewed or preprint publications.2 Media reports and prepublications on medRxiv and bioRxiv represent the most frequent mechanism for data sharing, with wide public reach and usually with little detail. However, … Continued

Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19

As the global COVID-19 pandemic continues, unabated and clinical trials demonstrate limited effective pharmaceutical interventions, there is a pressing need to accelerate treatment evaluations. Among options for accelerated development is the evaluation of drug combinations in the absence of prior monotherapy data. This approach is appealing for a number of reasons. First, combining two or … Continued

Certara 宣布首位在国际注册中心注册的人员,以评估对暴露于新冠肺炎 的医护人员采取的预防性治疗

Real-World Data on 10,000 Healthcare Workers to Inform COVID-19 Prevention Policies PRINCETON, N.J.—2020 年 8 月 13 日. Certara®, the global leader in biosimulation, has launched an international registry of healthcare workers to collect information on risk factors for developing COVID-19 and the use of preventative therapies.  The International Registry of Healthcare Workers Exposed to COVID-19 (UNITY Global) … Continued

Addressing the COVID-19 challenge with computer modeling & simulation

Each day, we wake up hoping for positive news about vaccines and therapies to combat COVID-19. More than 70 candidate molecules are being evaluated for repurposing to treat COVID-19. This number will grow thanks to the use of new combination therapies discovered under an aggressive, disciplined, and quantitative approach to evaluating candidates called model-informed drug development (MIDD)…

Model-based meta-analysis for comparative efficacy and safety of therapeutics for COVID-19

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.

Exploring the Effect of COVID-19 on HTA Bodies Now and in the Future

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.

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