The impact of the COVID-19 pandemic on oncology clinical trials and safety and efficacy studies has been immense. Over 100 trials have been suspended over recent months. Patients have foregone critical care and treatment and the slowdown will be felt for years to come. For patients with rare cancers, the consequences are even more dire.

The regulatory environment has been evolving in an attempt to keep pace with the changing needs of healthcare. Starting with HITECH legislation in 2009 continuing with the 21st Century Cures Act in 2016 and now under COVID-19, the FDA has offered increased flexibility and invited innovative models to develop new Real-World Evidence frameworks and methodologies that can help accelerate drug development and improve patient outcomes.

In this free webinar, two expert scientists from ConcertAI will discuss how novel study designs like External Control Arms (ECAs) are meeting the moment with custom, regulatory-grade data abstraction and advanced technologies. Speakers will discuss how conditions under COVID-19 and beyond are an opportunity to use ECAs to accelerate and reduce costs for specific types of research programs, especially rare cancers. Our scientists will explain how and when to use ECAs and why they are prime candidates for innovation for life sciences professionals working in rare cancers.

Using External Control Arms to Support Clinical Trials in a COVID-19 Era

Oct 6, 202011:00am EDT30 minutes

What You Will Learn

  • Expanding regulatory environment and opportunities for using ECAs
  • An overview of types of regulatory-grade RWD sources and RWE
  • Best conditions and use cases, i.e. rare cancers, for execution of ECAs
  • How advanced data and technologies products are accelerating innovative new study designs

Who Should Attend

Professionals who are involved in:

  • Real-World Data
  • RWE Center of Excellence
  • Clinical Development
  • Oncology
  • Rare Diseases
  • Medical Affairs
  • Market Access
  • Biostatistics

About the Speakers

 

Mark Walker, PhD, Chief Scientific Officer, Outcomes Science & Services

Mark consults on the development and execution of health economics and outcomes research (HEOR) and outcomes science studies and oversees ConcertAI’s growing team of HEOR scientists. Mark held the same position at Vector Oncology before its acquisition by ConcertAI. He joined Vector Oncology in 2007 after many years on the faculty at Washington University School of Medicine in St. Louis. Mark holds a PhD in Clinical Psychology. As a licensed psychologist, he worked clinically with breast, lung, and head and neck cancer patients at Siteman Cancer Center in St. Louis.

 

Anna Vlahiotis, MA, Associate Director in the Outcomes Science & Services

Anna has 15 years’ experience in health economics and outcomes research. Prior to joining the company in 2019, she conducted real-world evidence studies with IBM Watson Health (formerly Truven Health Analytics). She has engaged with all aspects of research on behalf of biotechnology and pharmaceutical sponsors, including study design, protocol development, oversight of data extraction, statistical analysis, interpretation of results and medical writing. Her research has resulted in publications across a variety of therapeutic areas, including oncology, endocrinology and neurology, and her work comparing health outcomes in depression was recognized nationally by the Academy of Managed Care Pharmacy in 2011. Ms. Vlahiotis previously served as Director in Outcomes Research at Express Scripts Holding Company, and as Research Assistant at the Washington University School of Medicine in St. Louis, MO. She holds an MA from the University of Missouri.