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Phase 1 Studies in Renal and Hepatic Subjects: Considerations and Best Practices in Design and Conduct

Track:
Nonclinical and Translational Development/Early Phase Clinical Development

Day & Time:
June 18, 1:30PM - 3:00PM (Pacific Standard Time)

Session Number:
358

Room Number:
7B

Level:
Intermediate

Type:
Forum

Title:
Phase 1 Studies in Renal and Hepatic Subjects: Considerations and Best Practices in Design and Conduct

Chair(s):
Bruce Morimoto, PhD
Executive Director, Applied Translational Medicine
Celerion, United States

Description:
This forum will present the collective experience of two specialized phase 1 sites and a contract research organization (CRO) which have collaborated in the conduct of special population studies in renal and hepatic subjects. Due to the complex nature of renal and hepatic diseases, there are special design and safety issues that include classification of subjects into severity categories, common complications of the underlying disease, and concomitant medications encountered. Inclusion and exclusion criteria need to be tailored to the unique aspects of these special populations. There have been recent regulatory documents that impact study design and conduct. Proper interpretation of these documents is crucial to the successful design and conduct of a regulatory-compliant trial. Best practices to operationalize these challenges will be reviewed from the perspective of the CRO and by the panel of North American primary investigator experts.

Learning Objective(s):
Describe considerations in planning and implementing hepatic and renal impairment studies; Discuss the underlying pathophysiology of progressive chronic kidney disease (CKD) and chronic liver disease, associated complications, and concomitant medications; Interpret the regulatory guidances for successful study design and conduct.

Presentation(s) & Speaker(s):
Pathophysiological and Safety Issues in Special Populations Phase 1 Research
Richard A. Preston, MD, MBA, MS
Professor, Clinical Medicine; Director, Clinical Pharmacology Research
University of Miami, United States

Special Considerations in Renal and Hepatic Clinical Trials
Thomas Marbury, MD
President
Orlando Clinical Research Center, United States

FDA Perspective
Nancy Xu, MD
Medical Officer, Division of Cardiovascular and Renal Products, OND, CDER
FDA, United States