Notice of Change to FOA PAR-19-100: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Exploratory Collaborative Innovation Awards (R21 Clinical Trial Optional)

Notice Number: NOT-TR-19-017

Key Dates
Release Date: March 14, 2019

Related Announcements
PAR-19-100

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

Please note the following changes:

Currently Reads:

 Part 1. Overview Information

Funding Opportunity Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public.  This funding opportunity announcement (FOA) will support investigators from two or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further dissemination within outside the CTSA Program consortium if appropriate.

Key Dates

Application Due Date(s)

March 8, 2019, July 11, 2019, November 9, 2019, March 8, 2020, July 11, 2020, November 9, 2020, March 8, 2021, July 11, 2021, November 9, 2021, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public. This funding opportunity announcement (FOA) will support investigators from two or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further dissemination  outside the CTSA Program consortium if appropriate.  

Background 

Translating biomedical discoveries into clinical applications is essential to improving human health. It is also a complex process with high costs and substantial failure rates.  These failures can result in delays of years or decades before improved patient outcomes result from discoveries in biomedical research. Under NCATS’ leadership, the CTSA Program supports a national consortium of medical research institutions — called hubs that work together to improve the translational research process to get more treatments to more patients more quickly.  The hubs collaborate locally, regionally, and nationally to catalyze innovation in training, research tools and processes.

The overall purpose of the CTSA program is to deliver scientific and systems change that solve the many outstanding problems limiting the efficiency, effectiveness, and reach of clinical translational research, and thus get more treatments to more patients more quickly across the country.  To do that, the program focuses on widely appreciated systematic barriers including (exemplary only; not intended to be exhaustive or exclusive):

  • Data interoperability
  • Biomarker qualification process
  • Regulatory science
  • Clinical trial networks
  • Patient recruitment
  • Electronic Health Records for research
  • Harmonized IRBs
  • Clinical diagnostic criteria
  • Clinical outcome criteria (e.g., PROs)
  • Adaptive clinical trial designs
  • Shortening time of intervention adoption
  • Methods to better measure impact on health (or lack thereof)
  • Data transparency/release
  • Integration of project management
  • Incentives/credit for team science
  • Incentives/credit for health improvements
  • Education/Training (scientific and cultural)
  • Collaborative structures

Innovations in these and related areas will be catalytic to translational efficiency and the development and delivery of interventions that improve the health of individuals and communities.  It is not expected that every hub should have the expertise or capability to address all of these issues, but the aggregate program can and should.  Beyond these strategic focus areas, this FOA defines domains of activity for the CTSA Program hubs that are intended to advance progress in these areas broadly, as well as a set of standards and resources that should be available at each hub to allow it to serve as a leading center for translational innovation and facilitate collaboration among the hubs. The academic health centers that make up the CTSA Program are referred to as “hubs” to indicate their central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers.  An important operational principle of all NCATS programs, including the CTSA Program, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations.  Depending on the problem being addressed, CTSA Program hubs are expected to develop and demonstrate solutions to translational roadblocks individually, as groups of hubs, and on a national level.

‘Translation’ is defined by NCATS as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public – from diagnostics and therapeutics to medical procedures and behavioral changes.  ‘Translational research’ is defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease.  ‘Translational science’ is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.  Translational research focuses on the specific case of a target or disease, whereas translational science is focused on the general case that applies to any target or disease.  Its focus areas are the common causes of inefficiency and failure in translational research projects (for example, incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability and ineffective clinical trial recruitment).  As these causes are the same across targets, diseases and therapeutic areas, advances in translational science will increase the efficiency and effectiveness of translational research in all therapeutic areas.  Like any other science, translational science seeks to elucidate general operative principles in order to transform translation from an empirical, phenomenological process into a predictive science.

Every stage of the translational process, from target validation through intervention development to public health benefit assessment, is currently fraught with inefficiency and in need of bold, new, innovative solutions.  Thus, there is a corresponding need for bold, new, innovative experimental approaches to identifying such solutions. NCATS' catalysis of the development, demonstration, and dissemination of innovations across the spectrum of translational science will advance its mission to transform the effectiveness of translation of discoveries from the laboratory, clinic, and community into tangible benefits to human health.  

Individual CTSA Program hubs, and groups of hubs, have developed and demonstrated the utility of innovations that improve the efficiency and effectiveness of many aspects of translational research and training.  The diversity of CTSA Program hubs, and their multiplicity nationwide, suggests that fostering cross-CTSA Program innovation development and implementation could transform the nation's translational effectiveness in unprecedented ways.  This FOA therefore seeks to encourage all CTSA Program hubs to collaboratively conceptualize, develop, and implement multi-site innovative experimental approaches that overcome translational barriers in science, operations, and training. 

We expect that, collectively, the projects funded under this FOA will have a transformative impact on the nation's translational science enterprise.

Revised to Read:

Part 1. Overview Information

Funding Opportunity Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public.  This funding opportunity announcement (FOA) will support investigators from three or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further disseminationwithin and outside the CTSA Program consortium if appropriate.

Key Dates

Application Due Date(s)

March 8, 2019, July 11, 2019, November 8, 2019, March 9, 2020, July 10, 2020, November 9, 2020, March 8, 2021, July 9, 2021, November 9, 2021, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

 

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The Clinical and Translational Science Award (CTSA) Program Collaborative Innovation Award (CCIA) supports collaborative research activities that develop innovative solutions that will improve the efficiency, quality and impact of turning laboratory, clinic and community observations into interventions that improve the health of individuals and the public. This funding opportunity announcement (FOA) will support investigators from two or more CTSA Program hub institutions (see below under Eligible Individuals) to either: 1) form new collaborations, or to 2) significantly expand the scientific scope of existing collaborations, or to 3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or disseminate a solution to a translational science problem developed at one hub to other hubs, in so doing testing its robustness to different hub environments and structures and adapting it for further dissemination  within and outside the CTSA Program consortium if appropriate.  

Background 

Translating biomedical discoveries into clinical applications is essential to improving human health. It is also a complex process with high costs and substantial failure rates.  These failures can result in delays of years or decades before improved patient outcomes result from discoveries in biomedical research. Under NCATS’ leadership, the CTSA Program supports a national consortium of medical research institutions — called hubs that work together to improve the translational research process to get more treatments to more patients more quickly.  The hubs collaborate locally, regionally, and nationally to catalyze innovation in training, research tools and processes.

The overall purpose of the CTSA program is to deliver scientific and systems change that solve the many outstanding problems limiting the efficiency, effectiveness, and reach of clinical translational research, and thus get more treatments to more patients more quickly across the country.  To do that, the program focuses on widely appreciated systematic barriers including (exemplary only; not intended to be exhaustive or exclusive):

  • Data interoperability
  • Biomarker qualification process
  • Regulatory science
  • Clinical trial networks
  • Patient recruitment
  • Electronic Health Records for research
  • Harmonized IRBs
  • Clinical diagnostic criteria
  • Clinical outcome criteria (e.g., PROs)
  • Adaptive clinical trial designs
  • Shortening time of intervention adoption
  • Methods to better measure impact on health (or lack thereof)
  • Data transparency/release
  • Integration of project management
  • Incentives/credit for team science
  • Incentives/credit for health improvements
  • Education/Training (scientific and cultural)
  • Collaborative structures

Innovations in these and related areas will be catalytic to translational efficiency and the development and delivery of interventions that improve the health of individuals and communities.  It is not expected that every hub should have the expertise or capability to address all of these issues, but the aggregate program can and should.  Beyond these strategic focus areas, this FOA defines domains of activity for the CTSA Program hubs that are intended to advance progress in these areas broadly, as well as a set of standards and resources that should be available at each hub to allow it to serve as a leading center for translational innovation and facilitate collaboration among the hubs. The academic health centers that make up the CTSA Program are referred to as “hubs” to indicate their central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers.  An important operational principle of all NCATS programs, including the CTSA Program, is to maximize impact via a catalytic approach: developing, demonstrating utility of, and then disseminating improvements in translational science and operations.  Depending on the problem being addressed, CTSA Program hubs are expected to develop and demonstrate solutions to translational roadblocks individually, as groups of hubs, and on a national level.

‘Translation’ is defined by NCATS as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public – from diagnostics and therapeutics to medical procedures and behavioral changes.  ‘Translational research’ is defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease.  ‘Translational science’ is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process.  Translational research focuses on the specific case of a target or disease, whereas translational science is focused on the general case that applies to any target or disease.  Its focus areas are the common causes of inefficiency and failure in translational research projects (for example, incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability and ineffective clinical trial recruitment).  As these causes are the same across targets, diseases and therapeutic areas, advances in translational science will increase the efficiency and effectiveness of translational research in all therapeutic areas.  Like any other science, translational science seeks to elucidate general operative principles in order to transform translation from an empirical, phenomenological process into a predictive science.

Every stage of the translational process, from target validation through intervention development to public health benefit assessment, is currently fraught with inefficiency and in need of bold, new, innovative solutions.  Thus, there is a corresponding need for bold, new, innovative experimental approaches to identifying such solutions. NCATS' catalysis of the development, demonstration, and dissemination of innovations across the spectrum of translational science will advance its mission to transform the effectiveness of translation of discoveries from the laboratory, clinic, and community into tangible benefits to human health.  

Individual CTSA Program hubs, and groups of hubs, have developed and demonstrated the utility of innovations that improve the efficiency and effectiveness of many aspects of translational research and training.  The diversity of CTSA Program hubs, and their multiplicity nationwide, suggests that fostering cross-CTSA Program innovation development and implementation could transform the nation's translational effectiveness in unprecedented ways.  This FOA therefore seeks to encourage all CTSA Program hubs to collaboratively conceptualize, develop, and implement multi-site innovative experimental approaches that overcome translational barriers in science, operations, and training. 

We expect that, collectively, the projects funded under this FOA will have a transformative impact on the nation's translational science enterprise.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

H. Timothy Hsiao, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-8928
Email: timothy.hsiao@mail.nih.gov