Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
TORONTO, Ontario (PRWEB) May 29, 2020
The onset of the COVID-19 pandemic created a global health emergency and a rush by the biopharma industry to develop therapeutics. The next wave of development will come from sponsors observing the evolving situation and making their own calculated assessments on how to make their contribution in the fight against SARS-CoV-2.
What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.
Some questions to be addressed include:
What are the important study design considerations?
- What characteristics define a case (e.g., suspected, probable, confirmed)?
- What are the risk factors for death or severe illness (e.g., scoring systems such as SOFA, APACHE, hemophagocytosis)?
- What are the comparators allowed in COVID-19 RCTs (e.g., placebo vs. standard of care/best available therapy vs. novel COVID-19 therapies)?
What are the predictors, biomarkers and virology endpoints to consider?
- What are the endpoints that the regulatory agencies will accept for an indication for COVID-19?
- Can viral shedding be used as an endpoint?
With so many products in development, what does the competitive landscape look like and what should Sponsors be thinking about as they move forward?
- What types of adaptations and flexibility need to be planned?
Join Brian Murphy, MD, MPH, FIDSA, Vice-President, Medical Department, Medpace, Hervé Momméja-Marin, MD, Vice-President, Medical Department, Medpace, Jennifer Gehlhar, MS, Vice-President, Clinical Trial Management, Medpace and Carrie Sheil, Sr. Director, Clinical Trial Management, Medpace in a live webinar on Friday, June 12, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Considerations for the Next Wave of COVID-19 Development.
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