Clinical Research Workshop, Innovations in Clinical Studies or Clinical Trials for Liver Diseases

Nov 13 2023
Room 302 - Hynes Convention Center
2:00 - 3:30 PM EST

Speakers

Bettina E. E. Hansen

Toronto General Hospital, University Health Network

Marina Serper

University of Pennsylvania

Quentin M. Anstee

Translational & Clinical Research Institute, Faculty of Medical Sciences, Newcastle University

Suthat Liangpunsakul

Indiana University School of Medicine

Jiabei Yang

U.S. Food and Drug Administration (FDA)

Description

The advancements in trial design, including adaptive platform designs, digital delivery and endpoints, are transforming therapy development in liver disease. Attendees will discover this transformation and learn about the increasingly important role of different study designs, how to run effective decentralized trials and how to leverage technology in the era of telemedicine and telehealth. Additionally, attendees will learn how to recruit an increasingly diverse population to clinical trials to better understand disease, health and therapies in the population where these conditions exist.

This session will also open attendees' eyes to the hot topic of recycling anonymous patient records, or clinical and administrative databases, to represent a placebo arm in randomized controlled trials for rare diseases. Finally, attendees will learn how to design and conduct effective investigator-initiated clinical trials and cohort studies, with a focus on early stage investigators and evaluating the role of investigators.

Objectives

  • Understand the role of pragmatic clinical trials and their application in liver diseases
  • Discuss alternative study designs and use of real world data as placebo-arm
  • Identify best practices for investigator initiated clinical trials and prospective cohort studies in liver disease