June 18, 2021

Choosing the right data to answer research questions is important, especially when it comes to developing an external control arm. External comparators or controls (also known as historical controls) have the potential to improve the evaluation of novel experimental agents in clinical trials.

While they are not a replacement for randomized, controlled clinical trials, external control arms are recognized by the Food and Drug Administration and used to accelerate drug development by leveraging external real-world data (RWD) to generate real-world evidence (RWE) in many disease areas.

Three leaders at STATinMED Research recently shared their thoughts about this topic. Watch this video featuring Sumit Verma, MS, Associate Director, RWE, Chief Medical Officer, Nora Janjan, MD, MPSA, MBA and Jason Drenning, PhD, Senior Vice President, Corporate Development & Operations.

You will learn more about key considerations including:

  • data source types and selecting the most relevant ones
  • data management and analysis
  • study design
  • customized “fit-for-purpose”
  • matching patients with inclusion/exclusion criteria to the control group

STATinMED Research is the authority in RWE. Since 2007, we have been selecting the most relevant RWD, developing insights, and delivering optimal solutions to help life science companies realize maximum value.

Contact us to learn more about STATinMED Research!  

Many thanks again to you and the entire STATinMED Research team for your help with the cohort comparison and timeline. It means a lot to us.

— Oncology Global Patient Outcomes Executive Real World Evidence at global biopharmaceutical company

We understand real-world evidence and solve problems with confidence. Contact the STATinMED Business Development team to learn more!