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Clinical Development

COVID-19 Webinars – Medpace Assembles Team of Experts to Discuss Considerations for Future SARS-CoV-2 Development

  • May 18, 2020

In these webinars, experts from Medpace’s medical department, regulatory, and operational teams will provide insights and considerations on how to accelerate product development for COVID-19 and answer some frequently asked questions, trends they see emerging, and considerations for future development.

COVID-19 Product Development and Clinical Trials: Considerations from European Regulatory Perspectives

Regulatory Agencies, Sponsors, CROs and sites all share the common goal of helping to get COVID-19 under control whether it’s by developing vaccines, diagnostics, or therapeutic agents for symptomatic treatments. To initiate clinical trials during this pandemic, flexibility in process and advanced planning are vital and should be properly balanced with regulatory expectations, shortages of medicinal products approved in indications other than COVID-19 and competition for the trial participants.

Real-time adaptation to a dynamic European landscape must be made under the conflicting pressures of rapid investigation—where the indication itself increases practical complexities, where there is increasing competition for patients and where there are geographically shifting phases of spread.

Join experts from Medpace’s regulatory and operational teams in this webinar as they provide insights and considerations on how to accelerate product development for COVID-19 during different stages:

  • Idea/Concept: Understanding options for validating a concept and setting development/regulatory pathways for new medicinal products with a potential to demonstrate benefit for the COVID-19 indication, where there are currently limited data
  • Re-purposing: Regulatory pathways including available mechanism for accelerations for re-purposing products where there is some existing data, irrespective of indication or current use
  • Rapid Authorisation: Optimising free, fast-tracked scientific advice, utilising PRIME, Accelerated Assessment and Conditional Marketing Authorisation pathways to their best advantage
  • Niche Trials: Leveraging focused country selection and submission approaches, considering varying levels of acceptance of trials in different countries
  • Expanded Trials: Clinical trial strategies and tactical approaches to accelerate start-up whilst allowing operational flexibility

Keys to success include engagement with European regulatory authorities (both European Medicines Agency and National Competent Authorities), maximizing existing mechanisms and understanding and executing the extraordinary COVID-19 specific measures now in place. Ultimately, this can save time and cost to expediting development and to achieve our common goal.

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Considerations for the Next Wave of COVID-19 Development

With shifting case numbers, fluid geographic hotspots and reprioritization of studies – how do Sponsors move their COVID-19 therapies forward?

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?
      • Differences in treatments, clinical presentation and complications
    • What factors should be considered during the setup phase to maximize recruitment?
      • Geography (e.g., shifting hotspots, potential for re-emergence)
      • Seasonality (e.g., will mirroring seasonal clinical trials be a valid strategy?)
      • Site restrictions and logistic challenges (e.g., supplies, patient access, ever-changing policies)
      • Public education (e.g., risk to participation in clinical research for COVID-19 and/or during a pandemic)

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Learn more on how Medpace can support COVID-19 trials and our testing capabilities here.