# Clinical Research in ALS & Related Disorders for Therapeutic Development (CReATe) - Pilot Core

> **NIH NIH U54** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2021 · $156,570

## Abstract

Project Summary / Abstract
The CReATe Pilot Core will be responsible for identifying and supporting the most promising clinical/
translational science that is relevant to clinical trial readiness for ALS and related disorders. Investigators
whose pilot projects are funded through this mechanism will become active members of the CReATe
Consortium. Historically, our efforts have focused on biomarker development and validation, which will remain
a high priority in our renewal cycle. We will continue to leverage partnerships with patient advocacy groups and
other stakeholders to enhance the productivity of the CReATe Pilot Core. Specifically, the Pilot Core will be
responsible for: (a) soliciting collaborative funding opportunities from patient advocacy groups and other
strategic partners; (b) developing a request for applications (RFA) for broad public release on an annual basis;
(c) convening an independent review committee that includes both members of CReATe (who are intimately
aware of CReATe infrastructure and resources that could benefit pilot projects) and external, independent
members; (d) working with awardees to enable access to CReATe resources; (e) securing necessary
regulatory approvals (including NIH approval for “delayed onset studies”); and (f) working with awardees to
help ensure that mutually agreed upon project milestones are met. The Pilot Core will identify and select for
funding the pilot projects that are relevant to the overall goals of CReATe, of the highest scientific merit, and
with the greatest potential to impact clinical trial readiness or to improve diagnosis and treatment of patients
with ALS or a related disorder. Metrics for the success of the CReATe Pilot Core will include: (1) number of
additional pilot projects that CReATe is able to support each year through partnership funding; (2) diversity of
projects supported (i.e. we aim to support pilot projects that are relevant to the full spectrum of diseases
studied by CReATe); (3) scientific productivity (progress towards clinical trial readiness or improved
diagnosis/management of ALS and related disorders), presentations, publications, and grants emanating from
the pilot project support; and (4) the extent to which pilot projects advance into larger scale projects that build
upon the work completed during the pilot stage of funding.

## Key facts

- **NIH application ID:** 10242885
- **Project number:** 5U54NS092091-08
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** Michael Benatar
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $156,570
- **Award type:** 5
- **Project period:** 2014-09-30 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10242885

## Citation

> US National Institutes of Health, RePORTER application 10242885, Clinical Research in ALS & Related Disorders for Therapeutic Development (CReATe) - Pilot Core (5U54NS092091-08). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10242885. Licensed CC0.

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