Foley partner Kyle Faget, co-chair of the firm’s Health Care Practice Group and chair of the forum, and partner Monica Chmielewski, vice chair of the firm’s Health Care Practice Group will be speaking at Dynamic Global Events upcoming 5th Clinical Trial Agreements forum. On August 21, Faget is speaking in a session titled “Apply Key Lessons from Decentralized and Remote Clinical Trials” and on August 22, Chmielewski is speaking in a fireside chat titled “Examine the Recent FDA Guidance Surrounding Digital Health Technologies.”
Clinical trial agreements are the backbone of every relationship between sponsors, clinical research organizations, and the research institution. Some of the biggest challenges when handlings these agreements are budget negotiation, communication transparency, language determination, and technological advancements. Attendees of the 5th Annual Clinical Trials Agreement forum will learn the best strategies on how to accelerate your clinical trial agreements (CTA) negotiations.
Apply Key Lessons from Decentralized and Remote Clinical Trials
In 2024, there will be a rise in decentralized clinical trials. CTAs must be modified to authorize the correct language for remote monitoring. During remote monitoring, sites are required to have home-health visits. This creates a burden on sites by requiring them to stretch their resources to accommodate remote monitoring as well as standard clinical trials. Will this impact the quality of remote monitoring staff and procedures?
This session will:
- Address the challenges facing remote monitoring from the site and sponsor perspective,
- Discuss how fair market value does not differentiate in cases with remote monitoring, and
- Explain the correct language for including remote monitoring.
Examine the Recent FDA Guidance Surrounding Digital Health Technologies
This recent U.S. Food a Drug Administration (FDA) guidance includes recommendations on the use of digital health technologies (DHT) to acquire data remotely. DHTs can increase efficiency for sponsors and sites to make research more convenient. How can these DHTs be employed in a study? Is there a legal risk when using DHTs in CTAs or informed consent?
This fireside chat will:
- Go over the recent FDA guidance on DHTs in order to understand how to properly utilize them,
- Debate the legal risk involved in DHTs when going over informed consent, and
- Identify how DHTs can improv y of clinical trial data acquisition.
