CTSA PROGRAM UPDATE

May 12, 2017

CTSA PROGRAM PI WEBINAR

NEW FORMAT!

The CTSA Program PI webinar formerly called the “CTSA Program Steering Committee w/PIs” call held on the 4^th Wednesday of the month from 2:00 – 3:00 ET has been restructured based on feedback from the hubs. The monthly webinar will feature a 30 minute presentation on NCATS updates and a 30 minute presentation on a demonstration/dissemination project by a hub.

If your hub is interested in presenting a demonstration/dissemination project, please send Samantha Jonson a 1 page abstract along with polling questions, discussion questions and/or other innovative methods for consortia interaction. The project should be broadly applicable to translational science in scope and have the potential for success with input, feedback and exposure from the consortium.

Abstracts will be reviewed by the CTSA Program Steering Committee on a rolling basis.

MAY 24 PRESENTATION: BUILDING A DRUG REPURPOSING NETWORK FOR THE CTSA PROGRAM CONSORTIUM

Drs. Richard Larson and Larry Sklar (University of New Mexico) will present an update to the Drug Rescue, Repurposing, and Repositioning Network (DR3N) which was established to accelerate and facilitate advancement of new treatments to clinical proof of concept studies. They would like to identify: 1) interested users and collaborators and 2) a common process for the CTSA Program network to engage with this resource.

The purpose of this network is to promote inter‐institutional collaboration across the CTSA Program network by funding innovative, translational research projects that involve two or more CTSA Program hubs. The CTSA Program hubs of the University of New Mexico Health Sciences Center (UNM HSC) in partnership with University of Kansas Medical Center (KUMC) and University of North Carolina (UNC) will facilitate collaborative investigations and team science throughout the CTSA Program network. DR3N will provide resources to new therapeutic concepts for existing drugs to new clinical research collaboration and trials. Specific project paths include entry of drugs via rescue, repurposing, or repositioning approaches with a common endpoint to clinical proof of concept trials. Collaborative DR3N projects will leverage resources at CTSA Program hubs to support rapid translation of new therapeutic concepts.

This presentation was originally showcased at the 2016 Fall CTSA Program in-person meeting in Chicago, Illinois.  NCATS looks forward to hearing about the progress made with the network and is excited to be part of the interactive discussion on the CTSA Program PI call! Check out their 2016 Fall CTSA Program meeting presentation slides for more information.

Questions?  Contact Samantha Jonson.

SMART IRB:  SPREAD THE WORD!

WHAT DO I NEED TO KNOW?

Funded by NCATS, SMART IRB is designed to streamline the IRB ethical review process for multisite studies involving as few as two sites to over one hundred. With SMART IRB, institutions can agree to allow one institution to become the reviewing IRB for a study, while the other institutions “rely” on that IRB’s oversight, from initial review to study closeout. SMART IRB is poised to support a wide range of collaborative research across the nation, and is freely available to all users. Just under 200 institutions have joined SMART IRB as of May 12, 2017.

SMART IRB, which stands for the “Streamlined, Multisite, Accelerated Resources for Trials,” is the result of many years of collaboration among CTSA Program hubs and the adoption of concepts that had appeared in several regional reliance models. In July 2016, Harvard Catalyst, the University of Wisconsin ICTR, and Dartmouth Synergy began working on what has become the SMART IRB Master Common Reciprocal Institutional Review Board Authorization Agreement (known as the SMART IRB Agreement).

ARE THERE IMPORTANT DATES TO KEEP IN MIND?

May 4, 2017: While institutions have already begun using the SMART IRB Agreement to enable single IRB review for their studies, SMART IRB launched the online reliance system, providing Participating Institutions and their investigators with a centralized system to request, track, and document reliance arrangements. During the month of May, there are also several opportunities to attend two important webinars: Getting started with SMART IRB and Implementing the SMART IRB Agreement.

September 25, 2017: The date that the NIH Single IRB Review Policy goes into effect. Starting September 25, any institution engaged in federally-funded multisite research must use a single IRB. SMART IRB facilitates this process, so it’s important for institutions to join now to start implementing this platform for their studies.

WHAT CAN CTSA PROGRAM HUBS DO?

Help spread the word. SMART IRB is a significant achievement for the CTSA Program, as nearly 200 institutions have signed on so far, including all the CTSA Program hubs. There are still hundreds more across the U.S. to sign on in the future.

We have an unprecedented opportunity to impact patient health by collaborating on a scale previously unimaginable. This platform will accelerate the launch of clinical trials by removing redundancies and other communications’ hurdles, while ensuring a high level of protection for research participants.

TO HELP SPREAD THE WORD YOU CAN:

Share information with your investigators, including our website, the recent NIH press release, and this brief animation video. As of May 4, let your investigators know they can use the SMART IRB online reliance system to request single IRB review for their studies.

Download a SMART IRB “badge” for your CTSA Program hub website.

Help us sign on your partners and collaborators by sharing contact information for IRB offices or institutional officials using this form.

WHO IS SMART IRB INTENDED FOR?

SMART IRB is used by investigators and IRBs and institutions:

Investigators can request and obtain single IRB review for their multisite studies; view the decision-making process in an accessible, easy-to-use online format; and track arrangements for their studies in one place.

IRBs and Institutions can use the SMART IRB Agreement and SOPs to enable single IRB review. The online reliance system makes it easy to track and document reliance arrangements and local context issues for each study, connect with the appropriate contact at each study site, and store and access reliance arrangements in one centralized place. The system guides institution users through a transparent decision-making process, making it clear when action is required.

Note: All Participating Institutions must designate and register a Reliance POC in order to be listed in the Online Reliance System; if your institution has not yet registered a Reliance POC, please contact us.

WHERE DO INVESTIGATORS AND IRBS GO FOR HELP?
Investigators should contact their SMART IRB point of contact (POC) to discuss using SMART IRB for their studies. For technical questions on the new online reliance system, please email SMART IRB.

IRBs and Institutions that have already joined can request a consultation to receive expert advice on serving as a Reviewing or Relying IRB. Institutions that have not yet joined, can contact an ambassador for help with this process. They can also check out our Resources page, and request help with any issue via email. 

Questions?  Contact help@smartirb.org.

COMMON METRICS

UPDATED DRIVER DIAGRAM AND CHANGE PACKAGE FOR CAREERS METRICS NOW AVAILABLE

The Tufts Common Metrics Implementation team has completed new versions of the Change Package and Driver diagram for the Careers metrics for use by all hubs. The new versions include drivers and example strategies to help meet the aim of increasing the number of women and under-represented persons in clinical and translational research. Download the Common Metrics Careers in CTR Change Package (Version 2) and Careers in CTR Driver Diagram (Version 2) now!

Questions? Contact Samantha Jonson.

NCATS + ELI LILLY EXTERNSHIP OPPORTUNITY

ROUND 2 DEADLINE EXTENDED TO MAY 15!

This is an opportunity for an externship in clinical and translational sciences at Eli Lilly and Company for scholars, trainees and investigators who are supported by the National Center for Advancing Translational Sciences (NCATS) – CTSA Program. The externship at Eli Lilly, a large pharmaceutical company, will support the training and education of participants in techniques and principles needed for translational research. Education and training will be team oriented, and in areas of mutual interest for the trainee/scholar and Eli Lilly. Scientific, theoretical and practical knowledge will include an appreciation of translational and commercialization challenges in developing and bringing a biotechnology or pharmaceutical product to patients.

This externship opportunity is open to CTSA Program trainees, scholars or investigators supported by CTSA Program hub award funds. The deadline was extended to May 15, so please do not miss out on this exciting opportunity!  For more information, please visit the NCATS website.

Questions?  Contact Joan Nagel.

ANNOUNCEMENTS 

REQUEST FOR INFORMATION (RFI): INVITATION TO COMMENT ON INCLUSION IN CLINICAL RESEARCH ACROSS THE LIFESPAN (NOT-OD-17-059)

In response to scientific need and a congressional mandate in the 21st Century Cures Act (P.L. 114-255), the National Institutes of Health (NIH) is convening a workshop of experts on the appropriate inclusion of pediatric and older populations in research studies involving human subjects.  A workshop will be held on June 1-2, 2017, to bring together experts in clinical research to discuss augmenting participation of these populations in NIH-funded clinical studies. The workshop will be videocast so that any interested individuals may view the presentations and reports. In addition, the NIH is publishing a Notice (NOT-OD-17-059) to solicit input from the wider scientific community and welcomes comments from the public concerning inclusion in research.

Questions? Visit NOT-OD-17-059 or contact Lisa Kaeser.

H NCATS: Improving Health Through Smarter Science

Connect with us!: https://ncats.nih.gov/connect