Limited Competition for the Continuation of Clinical Centers to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis Consortium (U01 Clinical Trial Optional) | RFA DK 20 504

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This is a limited-competition NIH funding opportunity (RFA DK 20 504) from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). It supports the continuation of established clinical centers within the NIDDK Gastroparesis Clinical Research Consortium (GPCRC, previously referenced as GPRCR).

What is the main purpose of RFA DK 20 504?

The main purpose is to keep the existing GPCRC consortium infrastructure operating so it can continue coordinated, multi-site research on gastroparesis. The program emphasizes understanding disease mechanisms (pathogenesis and etiology) and improving treatment through well-coordinated research across participating sites.

Is this opportunity open to new clinical sites that are not already part of the consortium?

No. This is a limited competition and is not intended to create a new national network of sites. It is designed to fund ongoing work at clinical sites that have already been participating in the NIDDK Gastroparesis Clinical Research Consortium.

Who is eligible to apply?

Eligibility is restricted to clinical sites that have participated in the NIDDK Gastroparesis Clinical Research Consortium. The opportunity also lists additional eligible applicant categories such as eligible agencies of the U.S. federal government and U.S. territories or possessions.

Are foreign institutions eligible to apply as the applicant organization?

No. Foreign (non-U.S.) institutions are not eligible to apply as applicant organizations under this announcement.

Can foreign components be included in the project?

Yes. While foreign institutions cannot be the applicant organization, non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by the NIH Grants Policy Statement.

What funding mechanism does this opportunity use?

This opportunity uses a cooperative agreement mechanism (U01), which typically means NIH has substantial scientific and programmatic involvement consistent with a coordinated, multi-site consortium model.

What does it mean that this is a cooperative agreement (U01)?

In this context, a U01 indicates NIH expects to be substantially involved in the scientific and programmatic aspects of the work, which aligns with running an organized consortium with shared goals, coordinated operations, and multi-site research activities.

What kinds of research activities does the consortium support under this FOA?

The FOA focuses on sustaining and expanding active patient cohorts and research platforms, enabling ongoing multi-site clinical trials, and providing a stable platform for ancillary studies (investigator-driven add-on projects) that use consortium cohorts, data systems, and coordinated operations.

Why is the FOA focused on maintaining existing cohorts and platforms?

The FOA highlights gastroparesis as complex and heterogeneous. Long-term, systematically collected multi-site data can help clarify how symptoms, gastric emptying, comorbidities, and treatment responses differ across patients and change over time.

Does this opportunity include support for pediatric research?

Yes. A central goal is to sustain and expand the consortium's active patient cohorts and platforms, including continued support for the first U.S. registry focused on children and adolescents with gastroparesis.

What is meant by "ancillary studies" in this FOA?

Ancillary studies are additional investigator-driven projects that can leverage the established cohorts, data systems, and coordinated consortium operations already in place.

What major shared resource is specifically highlighted as a consortium deliverable?

The FOA highlights the creation of an annotated biospecimen repository as a major collaborative deliverable.

What types of biospecimens are expected for the repository?

The repository is expected to include blood and stool samples and, when feasible, gastric tissue.

What does "annotated" mean for the biospecimen repository?

"Annotated" means the specimens are intended to be linked to well-characterized clinical information, such as participant demographics, symptoms, clinical course, physiologic testing results, medication exposure, and outcomes.

Why is linking biospecimens to clinical data important in this program?

The combined resource is intended to accelerate biomarker discovery and validation by making it easier to connect biologic signals with clinical phenotypes. This may support identifying gastroparesis subtypes and understanding which subtypes respond differently to therapies.

What types of biomarkers does the FOA suggest could be enabled by the repository?

The FOA notes the repository is intended to accelerate discovery and validation of biomarkers that could be useful for risk stratification (identifying patients more likely to have severe disease or worse outcomes) and for earlier detection.

Does the FOA mention any specific ongoing study the consortium will build upon?

Yes. The FOA explicitly notes that the consortium will build on the ongoing Pathological Basis of gastroparesis study.

What is the scientific emphasis of building on the Pathological Basis of gastroparesis study?

The emphasis is on better defining underlying tissue- and cellular-level changes associated with gastroparesis, strengthening the pathological and biologic foundation of the consortium's work.

How does this FOA aim to move the field forward scientifically?

By strengthening pathological and biologic foundations and linking biospecimens to deep clinical data, the program aims to move beyond symptom-based descriptions toward clearer disease mechanisms, which can support targeted therapy development and improved clinical trial design.

What is the award ceiling mentioned for this opportunity?

The listing provides an award ceiling of $250,000.

What is the CFDA number and general research category for this opportunity?

The activity is health-related research under CFDA 93.847 and is categorized as discretionary funding.

When was the application closing date for this announcement?

The original closing date for applications was December 16, 2020.

When was this announcement created?

The creation date listed is September 24, 2020.

Does the timing information suggest this is tied to a specific historical application cycle?

Yes. The dates provided (creation date September 24, 2020 and closing date December 16, 2020) indicate this specific announcement reflects a defined historical application cycle.

In one sentence, how should this opportunity be understood overall?

It is continued support for an established national clinical research infrastructure focused on gastroparesis, preserving and extending existing cohorts (including a pediatric/adolescent registry), enabling multi-site clinical trials and ancillary studies, and creating shared annotated biospecimen resources linked to deep clinical data to accelerate mechanistic and therapeutic progress.