COMMUNICATIONS

NIH ACHIEVES MILESTONE TO ACCELERATE MULTISITE CLINICAL STUDIES

CTSA PROGRAM PAVES WAY FOR NATIONWIDE SINGLE IRB MODEL

Read the National Institutes of Health (NIH) press release which highlights the success of the Clinical and Translational Science Awards (CTSA) Program and the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB authorization agreement.

NCATS wishes to acknowledge the hard work and skillful collaboration of our consortium to get more treatments to more patients, faster.

CTSA PROGRAM KL2 SCHOLARS

A NEW LINKEDIN PAGE FOR CTSA PROGRAM KL2 SCHOLARS

A component of the CTSA Program is the education and training of translational researchers. Most CTSA Program hubs have a KL2 program, which offers formal research training experience to scholars who already have an M.D., Ph.D., or equivalent doctoral degree.

NCATS is pleased with the success of this program, and wishes to make our larger community aware of outstanding KL2 Scholars and their recent achievements. Hence, we are starting a new LinkedIn page to feature scholars who have led innovative projects in the areas of workforce development, lifespan, methods and processes, collaboration and engagement, and informatics.

The current page features two scholars who presented their work in the KL2-Dyad panel at our Fall CTSA Program Meeting.  We will continue updating the page often, and hope it will serve as a place where scholars, mentors, and other investigators can see the different projects happening within our KL2 Program and connect with the Scholars leading them. We also welcome links to the page from current CTSA Program hub websites, social media pages and/or news articles to not only obtain a comprehensive view of the projects within our KL2 program, but also to make our larger scientific community and the general public aware of the contributions from our Scholars.

DO YOU KNOW A KL2 SCHOLAR WHO’S LEADING AN INNOVATIVE PROJECT?

Our KL2 Scholars are contributing to advancing translational medicine across all of our CTSA Program hubs. And while NCATS really wants to know about all of their projects, the breadth of the KL2 program makes it difficult for us to stay adequately informed. Hence, we are asking for your help.

We have designed a submission form where scholars, mentors, administrators or any other involved personnel from a CTSA Program hub can share innovative projects that are led by KL2 Scholars at their institution. We have proposed two simple criteria for submissions:

1. Though projects can be disease-specific, the emphasis must be on translational science and highlight advances in the scientific and operational principles of the translational process.

1. The KL2 Scholar must have led or contributed significantly to the planning, execution and reporting of the project.

We hope to review all submissions in a timely manner, and select some to post on the page and share with our broader community. NCATS thanks you for your help.

PLEASE FOLLOW THE NEW CTSA PROGRAM KL2 SCHOLARS PAGE AND SHOW YOUR SUPPORT! 

Questions?  Contact Amit Chaudhari.

COMMON METRICS UPDATE

METRICS DEVELOPMENT

The Accrual Metric Development Team and the Informatics Metric Development Team are developing their draft Operational Guideline(s) which will be presented at the in-person CTSA Program Steering Committee meeting on April 17th. NCATS will provide an update to the consortium on the Operational Guidelines following the Steering Committee meeting.

Questions?  Contact Samantha Jonson.

DOMAIN TASKFORCE (DTF) UPDATES

Workforce Development Domain Taskforce 

Harmonizing Core Competencies/Personalized Pathways Workgroup: The survey was deployed on March 10^th to map the 6 KL2 scholar phenotypes (definitions below) to several competency domains. The survey is under the stewardship of Susan Pusek (UNC), Beth Knudson (Iowa) and Rebecca Jackson (Ohio).

1. Community Engaged Researcher: Career goal is to perform research that involves a high level of collaboration between academic researchers and community partners.
2. Clinical Researcher: Career goal is to lead intervention studies and/or observational studies in the clinical setting.
3. Preclinical Bench Research Investigator: Career goal is to initiate the development of, and to provide supporting data for, the translation of scientific products toward use in a clinical setting.
4. Public Health Researcher: Career goal is to study factors and interventions that influence the health of populations that ultimately result in improved public health.
5. Data Sciences/ Analytics Researcher: Career goal is to work with large datasets to answer questions of biological/public health/policy relevance (e.g. epidemiological, “big data”).
6. Dissemination/Implementation Researcher: Career goal is to perform research to inform how to distribute, and to move efficacious health practices from clinical knowledge into routine, real-world use.

CTSA Career Sustainability Survey of KL2 Programs: The WG deployed their career sustainability survey of KL2 Programs in February 2017 with over 80% of the CTSA Program hubs completing the survey. The portal is still open for the remaining hubs with KL2 Programs to submit their response.

The Clinical Research Training for Investigators Workgroup: The WG is developing an on-line training course to build investigators’ operational knowledge and logistical skills in protocol development and implementation.  The WG has systematically organized their on-line modules according to the framework (see below).

INFORMATICS Domain Taskforce

In-person meeting: The Informatics DTF will hold an in-person members meeting on March 31^st from 8 – Noon PST in San Francisco after the AMIA Joint Summits on Translational Science Conference.  The agenda and confirmation emails will be sent to meeting attendees and speakers soon.

Imaging Informatics Workgroup: The Imaging WG met on March 10^th. The WG sent out a survey to all informatics representatives at each of the CTSA Program hubs. If you are interested in providing information about your institution’s imaging informatics, please contact C4.

Lifespan Domain Taskforce

In-person meeting: The in-person meeting will take place May 6, 2017 from 10- Noon PST in San Francisco. An agenda is being drafted.

Early Life Exposure Workgroup:  The WG has analyzed the Early Life Exposure Asset Survey data and is working on data dissemination.

Aging Working Group:  The WG is collaborating with Evan Hadley on the Adult and Aging Trial Innovation Center (TIC).

Single Disease Working Group: A white paper is in progress.

Collaboration/Engagement Domain Taskforce

In-person meeting: The Collaboration/Engagement DTF will hold an in-person meeting in Washington, DC on April 19, 2017 from 12:30 – 4:30 ET.

New Workgroup: The Collaboration/Engagement and Method/Processes DTFs have formed a new joint workgroup to assess the CTSA Program institutions’ strategies for engaging community stakeholder. The purpose of the workgroup is to identify key barriers and delays to research translation and demonstrate solutions as a process to improve clinical research.

Researcher Training and Education and Community Capacity Building Workgroup: The workgroup continues to refine the exclusion/inclusion criteria and categorize curricula collected for the environmental scan.

Dissemination & Implementation (D&I) Workgroup: The WG is planning to conduct a CTSA Program-wide environmental scan of the D&I resources within the consortium.

Developing Measures for Assessing and Improving Collaborations Workgroup:  The WG completed a draft summary report of published measures of research collaboration and engagement.

Methods and Processes (M/p) Domain Taskforce

In-person meeting:  The M/P DTF will meet on April 19^th from 8:00 – 11:30 ET at the Omni Shoreham Hotel, Palladium Room in Washington, DC.  Currently over 30 members have registered to attend the In Person meeting and 14 are listening in via GoToTraining.

Institutional Readiness for Team Science Workgroup: The WG is collecting promotion and tenure documents. Additionally, their poster was accepted for April 2017 ACTS Conference.

Designing and Analyzing Clinical Trials for Personalized Medicine (DACTPerM) Workgroup: The workgroup is working on a white paper.

Regulatory Science to Advance Precision Medicine (Joint Effort with Workforce Development DTF):  This workgroup held their first meeting on March 20^th.  The WG currently has members from All of Us (Precision Medicine Initiative), Methods & Processes DTF and Workforce Development DTF.

Questions? For more information on the DTFs (including points-of-contact), click here.

ANNOUNCEMENTS

HUB SPONSORED MEETINGS ON CTSA CENTRAL WEBSITE 

CTSA Program hubs can upload information about important meetings they host on the C4 Coordinating Center website, CTSA Central, in order to spread the word about sponsored conferences, activities, and/or items relevant to the CTSA Program and the advancement of translational science.  Hubs can upload conference or meeting information here.

Recent requests for addition are:

• Harvard University: “Harvard Catalyst Biostatistics Annual Symposium: p-Values, Hypothesis Testing and Reproducibility”
• The Greater LA CTSA Consortium (Southern California, UC-Irvine, and UCLA): “Regulatory Science Bootcamp Clinical Trials in “Special Populations”
• Boston University: “6th Annual Translational Science Symposium”
• University of Rochester: “Technology and Rare Neurological Diseases Symposium (TRNDS)”

Questions? Contact Colleen Lawrence.

CITSCIBIO HUB

The National Institutes of Health (NIH) Citizen Science Working Group invites you to take advantage of the Biomedical Citizen Science Hub (CitSciBio). Built on HUBzero®’s open source infrastructure, CitSciBio is a virtual collaboration space designed to help anyone interested in biomedical citizen science and crowdsourcing discover and share resources, form collaborative groups, and share expertise. It’s free, and anyone can join – those in government, academics, community partners, patients, and others.

For more information about CitSciBio, please visit website or sign up for a monthly newsletter.

Questions? Visit CitSciBio Hub Getting Started Guide and the knowledge base.

CTSA PROGRAM MEETING

SPRING 2017 CTSA PROGRAM MEETING

Updates from the Spring Meeting, including the agenda and selected speakers, were presented on the March Steering Committee and PI calls. Slides from the meeting were circulated to the CTSA Program PIs on Thursday, March 23^rd. The meeting agenda has been uploaded to the CTSA Central website.

The purpose of this meeting is to go beyond the traditional model of presentation and questions to one that emphasizes idea generation and collaboration amongst all of the attendees. Our goal is to bring together thought-leaders in translational science who can discuss approaches to catalyze grand opportunities in which the CTSA Program can have substantial impact.

Questions?  Contact Amit Chaudhari.

NIH NCATS: Improving Health Through Smarter Science

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