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The purpose of this NIH workshop is to convene multidisciplinary stakeholders to discuss the key methodological considerations for replication trials using omega-3 fatty acid (fish oil) therapy in individuals receiving maintenance hemodialysis as a case study.
The workshop will bring together investigators, patients, clinicians, trialists, and federal partners to examine issues related to trial design, endpoints, power, product formulation, adherence assessment, safety, recruitment, and implementation considerations for future U.S. based studies. Emphasis will be placed on strengthening capacity for replication trial design and applying the replication framework to omega-3 fatty acid interventions in the hemodialysis population.
Objectives
Review key methodologic considerations in replication trials
Explore the scientific underpinnings and key components of a replication trial of omega-3 fatty acids for the prevention of cardiovascular events in hemodialysis dependent adults in the USA
Planning Committee
NIDDK: Afshin Parsa, Kevin Chan, Susan Mendley, Kayla Hurd, Debbie Gipson
OD/Office of Dietary Supplements: Adam Kuszak
NCCIH: Wendy Weber
NHLBI: Robert Shamburek
Workshop Sponsors
National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK)
National Center for Complementary and Integrative Health (NCCIH)
Division of Intramural Research, Cardiovascular Branch, National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH
Registration Deadline
August 4, 2026
Agenda
Agenda
Day 1: August 3, 2026
12:30 p.m. – 12:45 p.m.
Welcome and Objectives for the Workshop Robert Star, M.D., Division Director, Division of Kidney, Urologic, &
Hematologic Diseases (KUH), National Institute of Diabetes and Digestive
and Kidney Diseases (NIDDK), National Institutes of Health (NIH)
Debbie Gipson, M.D., Program Director, KUH, NIDDK, NIH
12:45 p.m. – 1:00 p.m.
Replication Trial Methodologies and Examples Laura Pyle, Ph.D., Research Professor of Medicine, Division of
Metabolism, Endocrinology, and Nutrition, University of Washington,
Director of Biostatistics and Director of Integrative Data Sciences and
Multicenter Coordination, University of Washington Medicine Diabetes
Institute
1:00 p.m. – 1:30 p.m.
Overview of PISCES Clinical Trial of Fish Oil Supplementation in
Hemodialysis Charmaine Lok, M.D., Professor of Medicine, Faculty of Medicine,
University of Toronto, Senior Scientist, Toronto General Hospital Research
Institute
1:30 p.m. – 2:00 p.m.
Discussion: Replication Trial Methods & PISCES Study Moderators:
Susan Mendley, M.D., Program Director, KUH, NIDDK, NIH
Kayla Hurd, Ph.D., Program Analyst, KUH, NIDDK, NIH
Polyunsaturated Omega-3 Fatty Acids in Prevention of CV Events (Presentation & Discussion) Deepak L. Bhatt, M.D., M.P.H., M.B.A., Dean for Clinical Research-
Industry Partnership, Director of Mount Sinai Fuster Heart Hospital, Dr.
Valentin Fuster Professor of Cardiovascular Medicine, Icahn School of
Medicine at Mount Sinai
3:15 p.m. – 3:30 p.m.
Product Formulation and Implications for Replication Adam Kuszak, Ph.D., Health Scientist Administrator, Office of Dietary
Supplements, NIH
3:30 p.m. – 3:40 p.m.
FDA Drug Versus Supplement Mark Miller, Pharm.D., BCPS, RAC (US), CAPT, USPHS, Clinical Analyst,
Division of Cardiology and Nephrology, U.S. Food and Drug
Administration
3:40 p.m. – 4:15 p.m.
Discussion: Product Formulation and Drug vs. Supplement Moderator:
Robert Shamburek, M.D., Senior Investigator, Cardiovascular Branch,
Division of Intramural Research, National Heart, Lung, and Blood
Institute, NIH
4:15 p.m. – 5:00 p.m.
Who and Where: U.S. HD Population and CV Event Management Care Pathways
(Presentation & Discussion) Finnian McCausland, M.D., M.M.Sc., Associate Professor of Medicine,
Harvard Medical School, Nephrologist, Brigham and Women’s Hospital
Precious McCowan, Ph.D., Patient/Investigator
5:00 p.m. – 5:15 p.m.
Safety and Omega-3s: Adverse Events of Special Interest Christine Albert, M.D., M.P.H., Chief of Cardiology, Mass General Brigham
Hospital
5:15 p.m.
Adjourn for the Day
Networking dinner on your own
Day 2: August 4, 2026
8:00 a.m. – 8:30 a.m.
Meeting Rooms Open for Networking
8:30 a.m. – 8:45 a.m.
Welcome and Brief Highlights of Day 1 Afshin Parsa, M.D., Program Director, KUH, NIDDK, NIH
Endpoints (8:45 a.m. - 9:45 a.m.)
8:45 a.m. – 9:10 a.m.
CV and Mortality Endpoints, Ascertainment, and Adjudication Finnian McCausland, M.D., M.M.Sc.
9:10 a.m. – 9:15 a.m.
Tolerability: Patient Voice Kimani Feaster
9:15 a.m. – 9:45 a.m.
Discussion: Endpoints - CV/Mortality, Safety, and Tolerability Moderators:
Deepak Bhatt, M.D., M.P.H., M.B.A.
Susan Mendley, M.D.
9:45 a.m. – 10:15 a.m.
Genetics and Differential Outcomes (Presentation & Discussion) Floyd (Ski) Chilton, Ph.D., Professor, School of Nutritional Sciences and
Wellness, Director, Center for Precision Nutrition and Wellness, The
University of Arizona
Moderator:
Wendy Weber, N.D., Ph.D., M.P.H., Acting Deputy Director, National Center
for Complementary and Integrative Health, NIH
10:15 a.m. – 10:45 a.m.
Discussion: Sample Size, Stratification, and Power Considerations in
Replication Trials Moderators:
Laura Pyle, Ph.D.
Emily Leary, Ph.D., Chief, Biostatistics, NIDDK, NIH
10:45 a.m. – 11:00 a.m.
Break and Networking
11:00 a.m. – 11:45 a.m.
Discussion: Recruitment Strategies and On-Trial Monitoring
Approaches Moderators:
Paul Conway, Chair, Policy & Global Affairs, American Association of
Kidney Patients
Cynthia Delgado, M.D., Professor of Medicine, School of Medicine,
University of California, San Francisco
11:45 a.m. – 12:30 p.m.
Wrap-up Discussion Perspectives:
Rajnish Mehrotra, M.D., Belding H. Scribner Endowed Chair in Medicine,
Head, Division of Nephrology, Department of Medicine, University of
Washington School of Medicine
Robert Shamburek, M.D.
Precious McCowan, Ph.D.
12:30 p.m.
Adjournment Debbie Gipson, M.D.
Event Logistics
Registration
Registration Closed
Registration ended
Location
NIH Neurosciences Building 6001 Executive Boulevard Rockville,MD20852
This is a hybrid workshop. Virtual participation is available. For those attending virtually, the link will be distributed by email prior to the date of the event.
