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Dear Reader,

State-of-the-Art for Team Science

Last month, Michigan State University hosted the 10th International Science of Team Science conference. The conference provided an opportunity for Team Science researchers and practitioners to share evidence and best practices through oral sessions, posters, and other forums. The meeting also encouraged collaborations among individuals representing international and national institutions.  

Team Science is a growing approach defined as collaborative efforts addressing scientific challenges that leverage the strengths and expertise of multiple professionals trained in disparate fields. Some of the benefits derived by a Team Science approach include facilitating reach and adoption, increasing efficiency, and increasing productivity. At the same time, Team Science can address scientific/medical problems that are beyond the reach of a single investigator as well as generate in the process, new methodologies, approaches, and insights that allow previously unknown problems to be recognized and become tractable. In clinical and translational science, teams are essential for progress. The NCATS CTSA Program encourages interdisciplinary teams to tackle many of the barriers impeding translational science. The goal of interdisciplinary teams working together is to build upon the expertise and diverse viewpoints and philosophies held by different scientific disciplines to address important research questions, maximize efficiency in the research process, and achieve greater health impact. More than simply collaboration, Team Science recognizes, appreciates, and understands those factors that interfere with effective teams such as distinct language or jargon and theoretical underpinnings that differ across disparate scientific disciplines in order to achieve significant productivity.  

On the other hand, the Hollywood version of a scientist generally presents a socially awkward individual ensconced in a sub-sub-basement, scribbling hieroglyphics on a chalkboard and then rushing to the lab bench, mixing two brightly colored test-tubes, and shouting ‘Eureka’ (although perhaps Game of Thrones may offer a more realistic metaphor at many institutions) and the next day some child who had been near death is discharged from an adjacent hospital. I am particularly fond of ‘Star Trek’ where all alien diseases present as facial blotches and ‘Bones’ squirts something into a petri dish, sees something dissolve through the microscope, and then injects it into the patient after which the facial blotches immediately resolve and then everyone gets the treatment (unfortunately, the FDA did not make it to the 23rd century).

Ironically within the academic scientific and medical communities, the cinematic representation of a scientist still seems to dominate among institutional senior leadership as individual and independent contributions have been the predominant means by which scientists are recognized (in the form of tenure and promotion) for their scientific accomplishments. While recognition of team science contributions is slowly percolating through the system, our ability to address many aspects of improving translational science is hampered by this slow uptake.  

With the recent formal establishment of the International Network for the Science of Team Science (INSciTS) as a professional organization, a forum has been created for people to share the latest evidence for what works in team science and collaborate with one another to advance the Science of Team Science Field.   For information about future Science of Team Science conferences or membership go to https://www.inscits.org/.  We anticipate that this will catalyze much needed advances in team science and influence promotion and tenure policies at institutions invested in clinical and translational science.

Deep thought of the day:
I am always doing what I cannot do yet, in order to learn how to do it.
-  Vincent Van Gogh

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

THE SPOTLIGHT


When Definitions Matter: NCATS Support of Phase III Clinical Trials

When Definitions Matter: NCATS Support of Phase III Clinical Trials

During our May CTSA Program Webinar we presented specific language regarding limitations around the types of clinical trials (CTs) that NCATS is allowed to fund. The current Public Health Service (PHS) Act states: “The Center may develop and provide infrastructure and resources for all phases of clinical trials research. Except as provided in paragraph (2), the Center may support clinical trials only through the end of phase IIB.”

The referenced exception relates to therapies that are being developed for a rare disease or condition, for which NCATS is allowed to fund Phase III CTs provided certain conditions are met prior to award, including: 1) giving more than 120 day public notice of NCATS’ intent to fund the Phase III CT for a rare disease or condition; 2) no public or private organization provides a written credible intent to NCATS that the organization has timely plans to conduct Phase III CTs of a similar nature; and, 3) the development of the therapy does not increase the government’s liability beyond the award value.

Which Phase III Definition? So here is where definitions matter. The PHS Act does not define what qualifies as a Phase III clinical trial. To align with the intent of the PHS Act, the NCATS Policy uses the 21 CFR definition of a Phase III CT. This means that the clinical trial must be in support of the clinical development of an FDA-regulated product. The 21 CFR definition is what NCATS uses to decide whether or not we are allowed to fund certain CTs.  

In addition to our 2018 Notice to the Guide (NOT-TR-18-025), moving forward we will include the policy language in all future NCATS’ funding opportunities & Notices of Award. We are developing additional processes for early identification of potential 21 CFR-defined Phase III CTs to ensure that we comply with our PHS mandate. In addition, institutions and principal investigators are encouraged to discuss with their NCATS Program Officer any potential 21 CFR-defined Phase III CTs to be proposed and/or changes to planned Phase II CTs.

We hope this provides additional clarification on NCATS’ policy regarding clinical trial support and the definitions we are using.

For any questions, please contact your Program Officer.

WHAT'S NEW


Register now for the 2019 Fall CTSA Program Meeting!

Register now for the 2019  Fall CTSA Program Meeting!

The Fall CTSA Program Meeting will take place Thursday and Friday Sept. 26-27, 2019 at the Hyatt Regency Crystal City at Reagan National Airport. The meeting will focus on priority areas and opportunities for the consortium members to share best practices. The CTSA Program Steering Committee and Administrators Meeting will be held Thursday, with the kick off of the Fall Program Meeting with a hub Poster Session at 6 p.m. that evening. The full day CTSA Program Meeting will be held on Friday.

NEW Registration Process:

  • Registration for the meeting and Poster Session is easier than ever with the CLIC website!
  • You will need to be logged into your CLIC account to register (if you do not have a log-in, you can find out how to do so here). 
  • In addition to auto-filling your registration form with information from your account, these changes will allow you to confirm registration, edit registration details directly from your account, and resend the meeting confirmation letter. 

HEAL Initiative: Announcement of Collaboration Opportunities for Developing Drugs and Human Cell-Based Testing Platforms for Pain, Addiction and Overdose

HEAL Initiative: Announcement of Collaboration Opportunities for Developing Drugs and Human Cell-Based Testing Platforms for Pain, Addiction and Overdose

As part of the NIH HEAL initiative, NCATS continues its efforts for developing drugs and human cell-based testing platforms for pain, addiction and overdose complements the target identification, animal model efficacy testing, and human clinical network expertise of other laboratories to enable the development of new experimental therapeutics through drug screening in human-based, physiologically relevant in vitro systems, high efficiency chemical synthesis of new compounds, and IND enabling studies.

For more information about this notice please follow NOT-TR-19-018.

NCATS CTSA Program Support for Conferences and Scientific Meetings (R13/U13)

NCATS CTSA Program Support for Conferences and Scientific Meetings (R13/U13)

The purpose of the NIH Research Conference Grant (R13) is to support high-quality scientific conferences that are relevant to the NIH's mission and to public health. A conference is defined as a symposium, seminar, workshop, or any other organized and formal meeting, whether conducted face-to-face or virtually where individuals assemble. The primary purpose of the conference should be to exchange technical information and views, or explore or clarify a defined subject, problem, or area of knowledge.

NCATS Areas of Interest include scientific conferences or workshops consistent with its mission of advancing translational sciences through development, improvement or innovation in cross-cutting or generalizable approaches to basic, translational or clinical scientific research. In addition, CTSA Program Areas of Interest include activities within the scope of the CTSA Program and are responsive to one of the CTSA Program Strategic Goals. CTSA Program Conference Grants are single year awards for up to $25,000. Standard receipt dates apply:  April 12, Aug. 12, Dec. 2. A ‘Request to Submit’ letter is required at least 6 weeks before the targeted submission date and addressed to: ncatsreferral@mail.nih.gov.

For more information please contact Dr. Mary Purucker, M.D., Ph.D., Director, CTSA Program hubs at Mary.Purucker@nih.gov or click "Learn more" below.

 

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