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U.S. National Institutes of Health·United States of America

Single Source for the Continuation of the Physiology of the Weight Reduced State (POWERS) Study (U01- Clinical Trials Required)

Closes 11/17/2026$10M – $25MGrants Notice
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Description

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is issuing a single‑source solicitation for a Data Coordinating Center (DCC) to continue the multi‑center POWERS clinical trial, which studies physiological mechanisms of weight regain after lifestyle‑induced weight loss. The DCC will manage participant recruitment, weight‑loss interventions, study visits, biospecimen collection, storage, shipping, data curation, cleaning, analysis, and overall consortium coordination, including steering‑committee participation and dissemination of findings. Funding is provided via a U01 Cooperative Agreement, with NIH staff retaining substantial scientific involvement. The award is anticipated to start in April 2027 and run for approximately five years, supporting a large‑scale, multi‑site clinical trial infrastructure. • Single‑source award – only the incumbent DCC (University of Pittsburgh) may apply. • U01 cooperative agreement – NIH will have substantial programmatic involvement. • Required clinical‑trial activities: recruitment, intervention delivery, biospecimen handling, data management, and analysis. • Expected award value: multi‑million‑dollar, multi‑year contract (typical for NIH U01 DCCs). • Submission deadline: 5 PM local time, November 17, 2026; no late submissions accepted. • Key contacts: Mary Evans, PhD (NIDDK, email [email protected], phone (301) 594‑4578).

Attached files

Contact

Mary Evans, PhD(Agency Contact)

[email protected]

(301) 594-4578

Key dates

Opened
9/18/2025
Closes
11/17/2026
Projected award
4/1/2027
Duration
5 years

Last updated

Details

Type
Grants Notice
Industry
Healthcare and Medical Services
NAICS
541715
Solicitation №
RFA-DK-27-122

Budget estimate

$10,000,000 – $25,000,000

NIH U01 cooperative agreements for data‑coordinating centers of large, multi‑site clinical trials typically range from $2 million to $5 million per year, depending on scope, staff, and data‑infrastructure needs. Over a projected five‑year award period, the total anticipated funding would therefore be roughly $10 million to $25 million. This estimate assumes a full‑time DCC team (project managers, biostatisticians, data managers, and support staff), costs for biospecimen logistics, data‑sharing platforms, and NIH’s required sub‑award and administrative overhead. The actual ceiling could be higher if additional ancillary studies or expanded data‑analysis components are incorporated.

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