Notice Number: NOT-TR-18-013

Key Dates
Release Date: January 16, 2018

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is make modifications for PAR-18-244 "Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program (U01 Clinical Trial Optional)" for March 8, 2018 and subsequent due dates, to expand the list of high priority translational research opportunities to conduct novel clinical research studies intended to develop and test models of care for Opioid Use Disorders within medical settings including primary care, emergency departments, and neo-natal units.

In addition, this research provides the opportunity to explore many translational science barriers: how to recruit and retain difficult to reach populations, harnessing technology to simultaneously deliver effective care and facilitate the conduct of research, and integrating research into the workflow of busy clinical settings, etc.

Partnerships between CTSA Program hubs and affiliates in rural areas of the country most impacted by the opioid epidemic including the North East, the Appalachian Region, and New Mexico, as well as partnerships with NIDA Clinical Trials Network Nodes (https://www.drugabuse.gov/about-nida/organization/cctn/ctn/network-organization/nodes) in these regions are of strong programmatic interest.

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

Specific Objectives

Language Currently Reads:

• Some examples of such opportunities include but are not limited to:
• Development and implementation of innovative community engagement methods and technologies that demonstrably increase the efficiency and effectiveness of intervention development and deployment, and measurement of their effects on improving health outcomes.  Community engagement should be defined broadly to include local and distributed, physical and virtual communities.  Research aimed at engaging minority, vulnerable, or other understudied populations in translational research is one area of particular interest.
• Improving the consent process, for example simplifying and reducing the length of the consent forms without sacrificing content; ensuring that the consent form is commensurate with potential participants’ needs and is culturally sensitive; making the consent process more user-friendly through the use of visual aids or recorded video; in multi-site research, providing similar information across investigators and sites.
• Educating and training the translational research workforce through collaborative initiatives across multiple CTSA hubs that leverage local strengths, using innovative features such as shared, online resources, individualized training with focus on competencies rather than degrees, training in multi-disciplinary team science, regulatory science, entrepreneurship and experiential learning experiences, for example through externships in industry, regulatory agencies, or nonprofit organizations.
• Developing mechanisms for CTSA-catalyzed networks to identify and fast-track particularly promising translational research projects, thereby reducing the time required for intervention development or demonstration of unfeasibility.
• Adapting technology and methodology that are shown to be successful in other domains to address challenges in clinical and translational research.
• Fostering innovative multi-disciplinary collaborations that bring together new types of teams to solve particular clinical and translational research problems.
• Innovative clinical research studies or trials that use mobile technology and web- or phone- based communication to obtain information such as patient reported outcomes and remote biological measures. 
• Innovative clinical research designs, such as adaptive designs, serial “n of 1” design, or other approaches to small populations, which could overcome some of the challenges in evaluating interventions.
• Innovative approaches to the implementation of precision medicine
• Innovative methodologies that address translational research roadblocks specific to pediatric, geriatric, or other populations throughout the lifespan - e.g., new ways to develop outcome measures or validate biomarkers relevant to those populations, and enhancing lifestage-specific investigator training. 

Language Revised to Read:

• Some examples of such opportunities include but are not limited to:
• Development and implementation of innovative community engagement methods and technologies that demonstrably increase the efficiency and effectiveness of intervention development and deployment, and measurement of their effects on improving health outcomes.  Community engagement should be defined broadly to include local and distributed, physical and virtual communities.  Research aimed at engaging minority, vulnerable, or other understudied populations in translational research is one area of particular interest.
• Improving the consent process, for example simplifying and reducing the length of the consent forms without sacrificing content; ensuring that the consent form is commensurate with potential participants’ needs and is culturally sensitive; making the consent process more user-friendly through the use of visual aids or recorded video; in multi-site research, providing similar information across investigators and sites.
• Educating and training the translational research workforce through collaborative initiatives across multiple CTSA hubs that leverage local strengths, using innovative features such as shared, online resources, individualized training with focus on competencies rather than degrees, training in multi-disciplinary team science, regulatory science, entrepreneurship and experiential learning experiences, for example through externships in industry, regulatory agencies, or nonprofit organizations.
• Developing mechanisms for CTSA-catalyzed networks to identify and fast-track particularly promising translational research projects, thereby reducing the time required for intervention development or demonstration of unfeasibility.
• Adapting technology and methodology that are shown to be successful in other domains to address challenges in clinical and translational research.
• Fostering innovative multi-disciplinary collaborations that bring together new types of teams to solve particular clinical and translational research problems.
• Innovative clinical research studies or trials that use mobile technology and web- or phone- based communication to obtain information such as patient reported outcomes and remote biological measures. 
• Innovative clinical research designs, such as adaptive designs, serial “n of 1” design, or other approaches to small populations, which could overcome some of the challenges in evaluating interventions.
• Innovative approaches to the implementation of precision medicine
• Innovative methodologies that address translational research roadblocks specific to pediatric, geriatric, or other populations throughout the lifespan - e.g., new ways to develop outcome measures or validate biomarkers relevant to those populations, and enhancing lifestage-specific investigator training. 

• Some examples of research opportunities include but are not limited to:

• Development and testing of innovative engagement methods, technologies, and approaches to efficiently and effectively engage individuals with Opioid Use Disorders in research and clinical care and simultaneously develop effective models of care delivered within medical settings of interest
• Innovative clinical research studies or trials that develop and test mobile technology, web- or phone-based communication, and other technology devices and platforms to deliver and support the treatment of Opioid Use Disorders and to help prevent opioid overdoses.
• Developing and testing innovative incentives and approaches to foster multi-disciplinary collaboration and the creation of new clinical and research teams to deliver care to individuals with Opioid Use Disorders
• Innovative approaches to implementing, sustaining, and paying for effective interventions (medications and behavioral therapies) to address Opioid Use Disorders within medical settings of interest
• Innovative approaches to incentivize and engage clinicians in clinical research on models of care that are effective in screening and managing Opioid Use Disorders in medical settings of interest

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Philip J. Brooks, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-443-0513
Email: [email protected]