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Clinical Research in ALS and Related Disorders for Therapeutic Development (CReATe)

Biomarker Development/Validation Request for Applications
The CReATe Consortium, an NIH-funded Rare Diseases Clinical Research Consortium (RDCRC), in partnership with the ALS Association, is pleased to announce this request for applications (RFA) to support the discovery and/or validation of biomarkers that are relevant to development of therapies for patients with ALS or a related disorder (including primary lateral sclerosis [PLS], hereditary spastic paraplegia [HSP], progressive muscular atrophy [PMA], multisystem proteinopathy [MSP] and frontotemporal dementia [FTD]). Proposals to develop either wet (e.g. biological-fluid based) or dry (e.g. neuroimaging, neurophysiological) biomarkers are encouraged. Investigators submitting an application in response to this RFA may also request to use biological samples collected by the CReATe consortium.

Letter of Intent:
A letter of intent is required and should take the form of a single “specific aims” page.

Full Application Materials:
Applications that are invited for full submission should include
1.    A 4-page application in which the first page describes the specific aims of the proposal. The application should address the significance, innovation, scientific approach, and aspects of the scientific environment that are relevant to the successful completion of the proposed work.
2.    A 4-page NIH style-biosketch for the principal investigator and all co-investigators.
3.    A budget and brief budget justification.
4.    Letters of support, if relevant, demonstrating the availability of required biological samples.

Applications should be submitted via email to Dr. Michael Benatar (mbenatar@med.miami.edu) as an assembled PDF.

Biological Samples:
Investigators are encouraged (but not required) to utilize existing sample collections such as those housed at the Coriell Institute (https://www.coriell.org/), NEALS Biorepository (http://www.alsconsortium.org/neals_samples.php), or CReATe (contact Dr. Michael Benatar, (mbenatar@miami.edu).

Eligibility:
Any individual with the requisite scientific training, irrespective of country of residence or origin, may submit an application in response to this RFA.

Budget:

  • A maximum of $60,000 in total costs (direct and indirect costs) for a maximum period of one year may be requested.
    • For applications funded by the ALS Association, IDCs will be limited to 10%

Review Criteria:

  • Significance. Does the study aim to develop or validate a biomarker that is relevant to therapy development for ALS, PLS, HSP, PMA, MSP and/or FTD?
  • Innovation. For discovery projects, are the aims original? For validation projects, will the proposed work advance the field in a meaningful way?
  • Approach. Are the scientific methods sound? Is the study design appropriate to the intended purpose/application of the proposed biomarker? 
  • Investigator and environment. Is the investigator appropriately trained and well suited to carry out the proposed work? Is the scientific environment appropriately supportive of the proposed work?
  • Budget. Is the budget reasonable and proportionate with respect to the proposed work?

Reporting Requirements.
Successful applicants agree to:

  • Present their work at an annual CReATe consortium meeting
  • Appropriately acknowledge funding in presentations/publications
  • Submit a final report at the end of the funding period
  • Provide annual updates to the CReATe consortium on the progress of the work funded through this RFA.

Timeline:
RFA release: May 25, 2015
Letter of intent: June 26, 2015
Invitation to submit full application: July 17, 2015
Submission of full application: August 28, 2015
Notification of award: September 25, 2015
Earliest award period may begin: October 1, 2015

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