Designing for Replication: Methodological Frameworks and the Omega-3 Hemodialysis Case Study

Event Details

Purpose

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

1. Review key methodologic considerations in replication trials
2. 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

2:00 p.m. – 2:30 p.m.

Panel: Patient Perspectives
Kimani Feaster
Yolanda Moncrieffe
Moderator:
Kayla Hurd, Ph.D.

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 3:15 p.m.

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.

Travel

Hotel Accommodations

Bethesda North Marriott & Conference Center
5701 Marinelli Road
North Bethesda, Maryland 20852
Telephone: (301) 822-9200
Website
Reservations
Cut-off date: Monday, June 29, 2026

Government Room Rate

A limited block of sleeping rooms for meeting participants has been reserved at the Bethesda North Marriott & Conference Center. The rate is $183 per night for single occupancy, plus tax (13%). The room block will be in effect until Monday June 29, 2026, or until full, whichever comes first. Any room reservations received after this date will be accepted on a space- and rate-availability basis. Please be certain that the hotel provides you with a confirmation number for your reservation.

Reservation Dates

Book your arrival date as Sunday, August 2, 2026, and departure as late as Wednesday, August 5, 2026. If you require alternate dates, please contact Danielle Johnikin of The Scientific Consulting Group, Inc. (SCG).

Check-in and Checkout

Check-in time is 4:00 p.m., and checkout time is 12:00 p.m.

Cancellations

Failure to cancel your reservation in accordance with the hotel’s cancellation policy will result in a no-show fee of one night’s guest room rate plus tax on your credit card.

NIH Visitor Information

All visitors and their possessions are required to be screened, similar to the airport. You will also need to show a valid, government-issued photo ID (usually a driver’s license or passport). This screening is valid for one entry to the building. If you leave the building and wish to reenter, you will be required to be rescreened. Please allow for sufficient travel and screening time.

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