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

NIH RePORTER · NIH · U54 · $64,470 · view on reporter.nih.gov ↗

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
10020815
Project number
5U54NS092091-07
Recipient
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
Principal Investigator
Michael Benatar
Activity code
U54
Funding institute
NIH
Fiscal year
2020
Award amount
$64,470
Award type
5
Project period
2014-09-30 → 2024-08-31