AHLA Academic Medical Centers and Teaching Hospitals Institute: Decentralized Clinical Trials – a Modernized Approach for Clinical Trials During COVID-19 and Beyond

Virtual Program (ET)

Sarah V. Ferranti, Member of the Firm, will co-present "Decentralized Clinical Trials: A Modernized Approach for Clinical Trials During COVID-19 and Beyond," at the Academic Medical Centers and Teaching Hospitals Institute virtual program, which runs from January 25 to 26. The event is hosted by the American Health Law Association.

The unique challenges posed by COVID-19 have helped push the clinical trial industry towards innovative clinical trial models, including decentralized clinical trials (DCTs). Unlike traditional clinical trials, which are characterized by a series of onsite visits at a single clinical trial site, DCTs may be executed through use of technology, such as telehealth for conducting virtual visits, electronic systems for obtaining informed consent, or digital health technologies for collecting data from participants, as well as other “remote” strategies including shipment of investigational medical products to participants’ homes or use of local health care providers to assist with trial-related functions. This session will provide background on DCTs and address key operational and regulatory challenges in implementing DCTs at academic medical centers and teaching hospitals. 

Topics include:

  • Characteristics of DCTs, including fully decentralized trials and partially (hybrid) decentralized trials
  • Advantages of DCTs, including convenience, patient engagement, efficiency, and diversity, as well as potential drawbacks
  • The role of the investigator and the concept of a site in DCTs, including obligations to oversee “virtual” and “remote” providers
  • State requirements for telehealth and shipment of investigational medical products
  • Human subjects protection issues that arise in the context of DCTs, including privacy/security of participants' data, emergency medical access, remote monitoring of data, and adverse event reporting from multiple geographical areas

For more information, please visit Communities.AmericanHealthLaw.org.