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)
• National Heart, Lung, and Blood Institute (NHLBI)
• Division of Intramural Research, Cardiovascular Branch & Division of Program Coordination, Planning, and Strategic Initiatives
• Office of Dietary Supplements

Registration Deadline

August 4, 2026

Agenda

Day 1: August 3, 2026

12:30 p.m. – 12:45 p.m.

Welcome and Objectives for the Workshop

12:45 p.m. – 1:15 p.m.

Trial of Fish Oil in HD (e.g., PISCES Lok, 2025)
Presentation 20 minutes; Discussion 10 minutes

1:15 p.m. – 1:40 p.m.

Replication Trial Methodologies and Examples
Presentation 20 minutes; Discussion 5 minutes

1:40 p.m. – 2:15 p.m.

Panel: Patient Perspectives

2:15 p.m. – 2:45 p.m.

Discussion: Considerations for Replication Trial of Fish Oil in HD

2:45 p.m. – 3:00 p.m.

Break

3:00 p.m. – 3:30 p.m.

Polyunsaturated Fatty Acids in Prevention of CV Events
Presentation 15 minutes; Q&A 15 minutes

3:30 p.m. – 4:15 p.m.

Lipidomics of Fish Oil and Implications for Product Formulation, Assay for Adherence, and Safety
Presentation 15 minutes; Discussion 30 minutes

4:15 p.m. – 4:30 p.m.

FDA Drug Versus Supplement

4:30 p.m. – 5:00 p.m.

Who and Where: U.S. HD Population and CV Event Management Care Pathways
Presentation 10 minutes; Discussion 20 minutes

5:00 p.m. – 5:15 p.m.

Wrap-up

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

8:45 a.m. – 9:15 a.m.

Endpoints: CV and Mortality Endpoints, Ascertainment, and Adjudication

9:15 a.m. – 10:00 a.m.

Ascertainment of Participant Perspectives and Adherence to Nutritional Supplements
Presentation 15 minutes; Discussion 30 minutes

10:00 a.m. – 10:30 a.m.

Discussion: Sample Size and Power Considerations in Replication Trials

10:30 a.m. – 10:45 a.m.

Break and Networking

10:45 a.m. – 11:30 a.m.

Discussion: Recruitment Strategies and On-trial Monitoring Approaches

11:30 a.m. – 12:15 p.m.

Payer Perspective: Enablers and Barriers to Formulary Additions

12:15 p.m. – 12:30 p.m.

Wrap-up and Next Steps

12:30 p.m.

Adjournment

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.

Additional information on visiting the NIH can be found on the NIH Visitor Information page.