Date: April 22, 2013
Estimated Publication Date of Announcement: July 2013
First Estimated Application Due Date: October 2013
Earliest Estimated Award Date: June 2014
Earliest Estimated Start Date: July 2014
National Heart, Lung, and Blood Institute (NHLBI)
The National Heart, Lung, and Blood Institute intends to publish a new Funding Opportunity Announcement (FOA) that will encourage applications for research in support of development of novel point-of-care (POC) and implementation of existing technologies specifically for practical clinical applications which can guide diagnostic and therapeutic efforts in the heart, lung, blood, and sleep clinical research settings.
Among the areas of research encouraged in this initiative are evidence of the development and validation of the POC tool/technology (new or repurposed), including software development as necessary (Phase I), with subsequent feasibility testing in clinical studies (Phase II). In addition, the research should include an integrated system(s) or components that can be easily integrated into existing systems. Also, collaborative investigations combining expertise in clinical trials and regulatory requirements using POC devices in the areas of heart, lung, blood and sleep research will be encouraged and these investigators should also begin considering applying for this application.
The FOA is expected to be published in Summer 2013 with an expected application due date in Fall 2013. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
This Notice specifically encourages investigators with expertise and insights in the area of POC tools and technology that could enhance clinical trials in the area of heart, lung, blood, and sleep research to begin to consider applying for this new FOA.
This FOA will utilize the SBIR R43/R44 activity codes. It is expected that commercial POC products will be developed for use in the clinical research setting at the POC. Preliminary details of the planned FOA are provided below.
The FOA will support multidisciplinary teams/networks (i.e., from technical to clinical expertise) not only in the development of advanced technologies (e.g., bio-chips and platforms) but also in implementing existing POC products for use in heart, lung, blood, and sleep clinical research.
Applicants should describe technical approaches and POC
methodologies, specify how they will achieve the proposed clinical objectives,
and include details on quality control and assurance, including standards for
handling samples being tested by a device. Once the POC tool/technology/test
has been developed and validated, investigators will
be expected to test the feasibility of their product in heart, lung, blood, and sleep clinical studies.
Applicants will be advised to consider carefully the context in which their tools or technologies will be used to enhance clinical trials in the area of heart, lung, blood, or sleep research and the interoperability with existing health information technology systems. It is important to show early involvement of the FDA in regards to the design of a trial especially for a comparative trial.
Ideally, applications will include a bioinformatics and/or wireless technological component to link the POC-derived test data with other relevant patient data (e.g. data in Electronic Health Records).
The technologies developed with funding through the FOA are expected to be integrated systems or, if they are novel components, be easily integrated into existing systems. Proposed tools or technologies should interoperate and communicate with existing health information technology systems as appropriate. Some other technical features that are expected are the following: reliability, robustness, safety, simplicity, reliance on the appropriate baseline information, inclusion of software to support decision-making, and consideration of power consumption. Proposed tools and technologies should incorporate existing standards and consider regulatory requirements where appropriate. In addition, global health concerns, improved access to underserved areas, and cost-effectiveness should be highlighted.
APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.
Please direct all inquiries to:
Erin Iturriaga, RN, BS
National Heart, Lung and Blood Institute
6701 Rockledge Drive, MSC 7956
Bethesda, MD 20892