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.