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Michael G. Kurilla M.D., Ph.D.

NCATS Director of Clinical Innovation

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2019 Fall CTSA Program Meeting Decompression

By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation

October 11, 2019

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

 

This Mike's Blog was featured in October 2019's Ansible. Subscribe to receive upcoming Ansible newsletters.