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Dear Reader,

2019 Fall CTSA Program Meeting Decompression

Probably the biggest takeaway from the recent annual program meeting is that there simply isn’t enough time. However, we believe our goals for great presentations, lively discussions, and new collaborations were met.  You, the CTSA community, and our many partners from NIH, FDA, PCORI, IDeA CTRs, and USDA delivered. 

I’ll use the term “wicked problems” rather than the largely discussed “big hairy problems” to describe the major issues facing translational science. “A wicked problem is a problem that is difficult or impossible to solve because of incomplete, contradictory, and changing requirements that are often difficult to recognize.” The meeting certainly highlighted a plethora of wicked problems in achieving translation science’s goal of ‘delivering more treatments to more people, more quickly.’’

Translational research and drug discovery process inefficiencies: Improving the efficiency of the translational research processes requires a systematic and collaborative approach. The idea is to take early discoveries and therapies to communities faster while maintaining the highest quality and safety standards. From streamlining multi-site IRB processes, to accurately mining EHR data for participant eligibility, to improved multicenter research strategies, to sharing/testing tools in an accessible cloud environment; we discussed CTSA Program resources and tools available to our community of investigators/teams, including SMART IRB, IREx, ACT, TIN and CD2H.

Data ecosystem, data utility and data access/sharing/reporting: Technologies such as FHIR are experiencing an unprecedented uptake. The hope is that soon we can use all the available data for both prospective and retrospective data analyses, and ultimately, in support of IND/IDE and medical software development.  This will enable more effective use of Real World Data as we generate and test hypotheses without leaving the CTSA FHIR data ecosystem.  Our partnerships with FDA and PCORI 2.0, and our own CD2H, hold the prospect that by working together, we can develop data collection, analysis and reporting standards that impact the pace of the translational science process.

Inequality of access to translational research, including access for patients in rural areas: Providing more access to translational science is also an area where the CTSA Program can provide a positive impact.  Working together with partners such as the IDeA CTR and the USDA’s Extension Services we can create synergies in telehealth and teleresearch, allowing patients in rural and remote areas contribute to the development of specifically relevant new strategies and therapies, and to benefit from them.

Translational Scientists’ Professional Development: The way we communicate, interact and collaborate is different than a decade ago.  So is the way people view their professional development and work-life balance.  As a consortium, we need to evolve with the times and technology to make sure that young professionals in the area of translational science have the tools and resources to succeed and remain engaged in this field. We all need to recognize that cohort effects contribute to optimal work/life integration and the ‘best practices’ of one generation may not be best for another.

Lastly, a special shout-out to CLIC, CTSA Program SC and all of you who worked tirelessly to make this meeting a memorable one. I’m confident that working together we can continue finding innovative solutions to help speed up translational science processes, from discovery to therapies that can benefit our patients and communities.

Final thought:

“All truth passes through three stages: First, it is ridiculed; Second, it is violently opposed; Third, it is accepted as self-evident.” – Arthur Schopenhauer

Dr. K
Michael G. Kurilla, M.D., Ph.D.
Director of the Division of Clinical Innovation, NCATS

 

THE SPOTLIGHT


We Want to Hear From You: RFI Enhancing the Clinical and Translational Science Awards (CTSA) Program NOT-TR-19-027

We are seeking comments from all stakeholder communities on how NCATS can strengthen  the Clinical and Translational Science Awards (CTSA) Program to meet its broad scientific mission to improve the efficiency and effectiveness of clinical research and translational science. Key stakeholders include academic health centers, scientific research organizations, healthcare delivery organizations, and healthcare providers; individuals involved in the translational pipeline to improve health in the community including those public and private partners who fund such research and services; those who provide education and training in the translational science process; and members of the public who are advocates, clinicians, patients, and community leaders seeking better diagnostics, treatments, preventions, cures, and overall general good health.

All comments must be submitted online.

Responses must be submitted by October 25, 2019.


WHAT'S NEW


Seeking New Steering Committee Members

NCATS is seeking nominations for new CTSA Program Steering Committee (SC) members! A total of 7 slots are available – 5 UL1 PIs, 1 KL2 PI and 1 TL1 PI. When determining appointments, NCATS considers a balance of geography, T1-T4 focus, gender, grant period, submission explanation and diversity to name a few. If you would like to self-nominate or suggest a fellow PI, please review the eligibility criteria and submit the PI name, institution, and brief explanation (no longer than 1 paragraph) to Samantha Jonson by Friday, November 1.

Now Accepting Applications for 2020 CTSA Program Working Groups

The CTSA Program Steering Committee is now accepting proposals for new Working Groups. To submit a proposal, please log on to the CLIC website and complete this form. Groups or individuals interested in forming a Working Group are required to propose and deliver well-defined projects or deliverables that fill identified translational gaps and/or further the CTSA Program objectives in high priority areas within clinical and translational science. 

Any group or individual within the CTSA Program is eligible to submit an application for a Working Group. Working Groups that are approved by the CTSA Program Steering Committee will be supported by CLIC. The deadline to submit a proposal is Thursday, Oct. 31, 2019.

CLIC Announces NUCATS as the 2020 Un-Meeting Partner

Following a careful evaluation process, CLIC has selected its next Un-Meeting partner. Northwestern University Clinical and Translational Science Institute (NUCATS) will host an Un-Meeting on the topic of “Lifespan and Life Course Research: Integrating Strategies” in Chicago on Monday March 2, 2020. The Un-Meeting will be led by Susanna McColley, MD with support from CLIC. Please stay tuned for more details on meeting logistics and how to register. In the meantime, you can reach out to unmeetings@clic-ctsa.org with any questions.

The CTSA Program Collaborative Innovation Awards (CCIAs): Upcoming Due Date - November 8, 2019

The CCIA Program supports awardees to either: (1) form new collaborations, (2) significantly expand the scientific scope of existing collaborations, (3) engage new collaborators in pre-existing collaborations to solve a translational science problem no one hub can solve alone, or (4) disseminate a solution to a translational science problem developed at one hub to other hubs, thereby testing its robustness to different hub environments and structures and adapting it for further dissemination within and outside the CTSA Program consortium if appropriate.

For the Collaborative Innovation Award (U01 Clinical Trial Optional), an application must involve investigators who are supported by CTSA Program hub institutions from at least three different and currently funded CTSA Program hubs as of the due date of the application or alternatively, an application may involve investigators from at least two different and currently funded CTSA Program hubs (of which one must be the contact PI on the application) and one or more currently funded NIH Institutional Development Award (IDeA) Program Infrastructure for Clinical and Translational Research (IDeA-CTR) participating institution, as of the due date of the application. 

For the Exploratory Collaborative Innovation Awards (R21 Clinical Trial Optional), an application must involve investigators who are supported by CTSA Program hub institutions from at least two different and currently funded CTSA Program hubs as of the due date of the application.

Diversity and Re-Entry Research Supplements to UL1 Awards

The CTSA Program is committed to improving the diversity of the workforce and to supporting re-entry into active research careers for those individuals that have taken an eligible hiatus from research. We would like to take this opportunity to highlight some of our outstanding program awardees who, with NCATS support, have advanced their careers as translational scientists. As a reminder, CTSA Program supports Diversity and Re-Entry Research Supplements to active and eligible UL1 grants through the following funding opportunity announcements (FOAs): 

PA-18-906: Supplements to Promote Diversity in Health-Related Research

PA-18-592: Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers

Please see the NCATS specific guidance for more information. Applications are due November 1.

Request for Information (RFI): FHIR Use of the Health Level Seven International (HL7) Fast Healthcare Interoperability Resources (FHIR) for Capturing and Sharing Clinical Data for Research Purposes NOT-OD-19-150

NIH is soliciting input from all interested stakeholders, including researchers, health care providers, academic institutions, medical institutions, health IT developers, professional organizations or societies, as well as other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the view of their organization and membership as a whole.

Responses must be submitted no later than November 23, 2019.

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