Partner Kyle Faget, Co-Chair of Foley’s Health Care Practice Group, will be speaking on the panel “How Decentralized Clinical Trials Are Changing the Clinical Trial Landscape and What You Need to Know”. Kyle will be joined by Dr. Clare Grace, Chief Patient Officer at Parexel and Chris Dorko, VP and Risk Management Resources Officer at Berkley Life Sciences.
This presentation will address how the clinical trial landscape is shifting from a traditional brick-and-mortar context to include decentralized hybrid models. This approach incorporates telemedicine and the deployment of clinicians that can undertake certain protocol-required activities in a subject’s home. The advantages and burdens presented by this model will be discussed. Subject recruitment, subject adherence to protocol-required visits, and geographic footprint will be explored as potential advantages enjoyed by decentralized trials. Telemedicine practice standards will be discussed regarding hurdles to operationalizing a decentralized clinical trial model. Topics such as licensure, modality, and informed consent will be addressed.