COMMUNICATIONS

CTSA PROGRAM UPDATE

July 13, 2018

CTSA PROGRAM PI MEETINGS

The next CTSA Program PI Meeting is scheduled for July 25, 2018 at 2:00 p.m. ET. If you’re interested in registering for the meeting, click on this link and complete the brief registration form. Once completed, a confirmation message will be sent to you with a dedicated URL to connect you to the series of calls. You will also have the opportunity to add these calls to your calendar from the confirmation message. To access previous meeting materials such as presentations and recordings, visit the Principal Investigators Group page on the CLIC website.

If you have a topic that you’d like to suggest for discussion in furture meetings, please use the CLIC Suggestion Box and select “PI Meeting Topics.” The Suggestion Box can also be used to suggest topics for the Steering Committee, the CTSA Program Meetings, Consortium Activities or other.

CTSA PROGRAM WOW! FACTOR STORY SUBMISSIONS

NCATS has revamped their ‘Success Story’ submission form: the new and improved ‘WOW! Factor’ form allows hubs to easily share stories that illustrate how the CTSA Program is helping improve translational science and public health, in their communities and beyond. Selected information from the submission may be further developed into future NCATS and/or CLIC communications. Your CTSA Program Officer may contact you for additional information.

You can access this submission form by logging into the CLIC website and clicking Send a CTSA Program WOW! Factor Story to NCATS (this link may not work if you are not logged in).

Hubs can still submit ‘Consortium News’ stories via the CLIC website. These are ‘everyday’ news stories/hub updates to be highlighted as a blurb on the CLIC site and potentially on the CLIC Twitter.

Questions?  Contact Clare Schmitt

CLIC UPDATES

UN-MEETING REQUEST FOR APPLICATIONS

On June 2, CLIC hosted the CTSA Program’s first ‘Un-Meeting,’ focused on addressing the opioid crisis through translational science and research. More than 100 attendees from across the country participated in this dynamic and untraditional event, aimed at fostering new collaborations and promoting team science. In the coming months, CLIC will open a request for applications to CTSA Program hubs interested in hosting their own Un-Meeting on a topic of their choice. The selected application will receive funds to support the meeting, along with planning guidance and materials. More details on the application process will be shared as they become available.

To learn more about the Un-Meeting concept, check out the brief video in this tweet. You can also read a recap of June’s event in this blog, which links to meeting materials and presentations.

CLIC WEBSITE UPDATES

New Surveys Page  

The CTSA Program supports high quality translational and clinical research locally, regionally and nationally. Surveys are one way to efficiently conduct research and collect pertinent information. In an effort to consolidate CTSA Program-related surveys and their respective results, CLIC has created a Surveys page, which houses CLIC-distributed survey summaries and results all in one place.

The page can be accessed by visiting the Tools & Resources page and clicking on CLIC-Distributed Surveys. Please note that much of the content within this page requires you to login first to access.

New Communications Group Page

In order to better support CTSA Program hub communicators, CLIC has developed a Communications Group page on the CLIC website. This page houses various items for members of the communications group – a Communications Toolkit, Meeting Information, a communications-specific FAQ and a communications-specific forum (which is coming soon). This page will evolve and grow as we continue to gain an understanding of what communicators find most useful.

The page can be accessed by visiting the Groups page and clicking on Communications. Please note that many of the resources within this page requires you to login first to access.

COMMON METRICS UPDATES

COMING SOON! COMMON METRICS HUB-SPECIFIC REPORT

On July 31, hubs will receive their individual report on data submitted in 2017. The hub PI, Evaluator, and Administrator will receive the report.

The report will include quantitative and qualitative analyses of the first three metrics. The hub specific comparisons to the rest of the consortium present your Common Metrics team(s) and internal stakeholders new opportunities to engage in discussions regarding ways to improve local data, potential best practices, creation of cross-hub learning collaborations, and much more.

The CLIC Common Metrics team looks forward to working with you to improve the future metric data collection and reporting. This is the first hub specific metrics report, and we look forward to feedback to improve future analyses and visualizations to enhance their usefulness for the hubs.

REMINDER: 2017 COMMON METRICS DATA SUBMISSION

Your final date to submit 2017 hub data values and updated Turn-the-Curve (TTC) plans is  August 30, 2018. This involves updating your hubs Common Metric values through 2017 and modifying, as needed, your TTC plans for the first three metrics: Careers in Clinical and Translational Research, IRB Duration, and Pilot Funding and Publications. Updating your TTC plan includes describing any changes to underlying factors, the progress you have made by implementing selected strategies, and the results of any additional measures you are using to track progress with these strategies. As in the past, work with your teams (evaluator, content expert(s), data support person, others as warranted) and, as always, assistance is available from our Common Metrics team at common_metrics@clic-ctsa.org.

INFORMATICS METRIC UPDATE

The CLIC Common Metrics Implementation team is on schedule for a September 2018 roll out of the Informatics Common Metric (ICM). In response to feedback from the pilot, CLIC will be releasing an ICM Team Formation Guide during the month of July. This document will provide guidance drawn from the experience of the pilot sites about configuring your ICM team prior to the September launch. Also on deck for release this summer are resources for an Overview of Informatics; an Overview of Results Based Accountability and TTC Planning; and Informatics and RBA/TTC Planning: Bringing it All Together. We are excited to support the Consortium through a smooth roll-out of this new metric!

MEDIAN ACCRUAL METRIC

Eight CTSA Program hubs volunteered to Pilot Test the Accrual Metric between August and December 2017. The Tufts CTSI coordinated the Pilot Test process, assessing the feasibility of collecting the data elements included in the accrual metric, and has provided the first version of the report including recommendations to consider. The Accrual Metric development working group, which consists of Evaluators, Administrators, and PIs from various Hubs, has reviewed the recommendations. The working group will revise the Operational Guidelines to reflect the feasibility Pilot Test experiences and recommendations.

Questions?  Contact CLIC Common Metrics implementation team.

DOMAIN TASK FORCE (DTF) UPDATES

YOUR FEEDBACK REQUESTED – DTF STRUCTURE SURVEY

We Want Your Feedback on the Domain Task Forces!
The NCATS CTSA Program Steering Committee Working Group on the Doman Task Force (DTF) would like your feedback on the DTF structure. Your participation is extremely vital as NCATS will incorporate your feedback and make changes to the DTFs to help enhance and improve operations.  Please check your email inbox for your individually tailored email invitation! The brief questionnaire closes on Monday, July 16, 2018. If you did not receive an invitation and would like to participate, please contact clic@clic-ctsa.org for a personalized link.  Please note that some DTF participants who have provided CLIC with more than one email address may have received survey requests to these individual emails. We request that each DTF participant complete the survey once.  If you’ve already completed this survey, thank you! You may disregard any future reminder emails.

Please see the tentative timeline of CTSA Program Steering Committee activities below.  CTSA Program consortium members will have the ability to provide input on any revisions to the structure at the in-person CTSA Program meeting in October!

COLLABORATION & ENGAGEMENT DTF

On June 19, the Dissemination, Implementation, and Knowledge Transfer Working Group presented a webinar titled Dissemination and Implementation Science: What is it and why is it critical to Translational Science? You can view a recording of the webinar here.

METHODS & PROCESSES DTF

The Institutional Readiness for Team Science Working Group has finalized the Great CTSA Program Team Science Contest and will be presenting to the CTSA Program Steering Committee for approval.

Promotion and Tenure Document Data Coding Manuscript:

• Analysis has been completed and they are in the early stages of writing an initial draft

WORKFORCE DEVELOPMENT DTF

Meetings & Events

The next Workforce Development full DTF meeting is scheduled Wednesday, August 8, 2018, 3:00-4:00 p.m. and the agenda includes the following:
At the face-to-face meeting in April, attendees strongly indicated that future efforts should focus on best practices for robust and meaningful data collection on trainees and demonstrating impact of training programs. We will begin a discussion of this topic at the August full DTF meeting, with the anticipation of forming a work group of interested DTF members.

At the August meeting we will hear from:

• Workforce Development Lead Team: “Face to Face Meeting Feedback”
• Barry Coller, PI Rockefeller: “Lessons Learned from the Graduate Tracking Survey System (GTSS) over 10 years”
• Jason Owen-Smith, Executive Director Institute for Research on Innovation and Science (IRIS): “Using IRIS to analyze the impact of translational science training”
• IGNITE Presentations: To engage the entire DTF, we are putting out a new call for IGNITE presentations to start with this August meeting. Please submit 1 – 2 slides to share best practices from your Hub, particularly those that focus on innovative or effective methods for collecting metrics and displaying outcomes of translational research training. Please submit by Wednesday, July 16. The IGNITE presentations will begin with the August meeting, as time permits, and continue during our full DTF meetings
• Workforce Development Lead Team: “Wrap up and Next Steps”

Working Group: Harmonizing Competencies
The Harmonizing Competency/Personalized Pathways Working Group is currently working on manuscript preparation. The manuscript will report the results of the survey that asked respondents how they interpret and use CTSA Program Core Competencies when advising learners across clinical/translational researcher phenotypes. The group presented a poster on this work at the recent ACTS meeting last April. There was active discussion and interest in learning how CTSA Program educators define the knowledge, skills and abilities important for clinical/translational researchers, and use this information to help learners design personalized training pathways.

UPDATES FROM OTHER CTSA PROGRAM INITIATIVES

ACCRUAL TO CLINICAL TRIALS (ACT) NETWORK

The ACT Network held its first breakout session at the i2b2 tranSMART Harvard Symposium on June 28. The six hour session included conversations lead by the SHRINE, i2b2, and ontology teams to review the current network status, discuss best practices, and prepare for the future of participant identification. Current, onboarding and new ACT sites were in attendance (over 40 participants from among the 48 ACT CTSA Program institutions) and added to lively conversation around site related issues and overarching challenges across the network. Session recordings will be available here in the coming weeks. In addition, two ACT Network sites have officially launched to local end users. More sites are slated to launch throughout the summer and we’ll soon start to onboard the next wave of sites to the network.

For general information on the ACT Network, you can reference our new website. If you are interested in registering for the ACT monthly newsletter, please sign up here.

TRIAL INNOVATION NETWORK (TIN)

Have you logged into your Trial Innovation Network dashboard? As a member of your Trial Innovation Network Liaison Team, you have access to view your Network study activities including proposal submission status and EHR Cohort Assessment requests. New features and enhanced functionality continue to improve the Network dashboards. Check back for updates. To access your Network dashboard, visit www.trialinnovationnetwork.org and select the ‘Network Login’ button. If this is your first time accessing Network dashboards, please select ‘Create A Profile’ and complete the registration steps.

The TIN continues to accept investigator proposals for multi-center clinical trials and studies. Visit our website to learn more about the proposal process, see upcoming webinars, and search our Recruitment & Retention toolkit. For the latest updates from the TIN, sign up for our monthly newsletter.

Upcoming Webinars 

The Trial Innovation Network Toolkit Overview Collaboration Webinar is taking place on July 18, 2018 at 12:00 p.m. ET. This webinar will include an overview of the resources available on the Trial Innovation Network Toolkit. From study design to participant recruitment and engagement, the Trial Innovation Network offers many self-service tools and resources to help investigators throughout the entire life cycle of their projects. Click here to register.

The Patient, Provider, Public Working Group Open Forum is taking place on July 19, 2018 at 2:00 p.m. Consuelo H. Wilkins, MD, MSCI, will describe the framework for stakeholder engagement within the Network. The framework will define engagement principles, outline the emerging stakeholder engagement plan and define engagement pathways for those who are interested in connecting with patients, providers and the general public. Click here to register.

IRB RELIANCE EXCHANGE (IREx)

IREx now offers a Status Summary dashboard to help Coordinating Centers (CC) and Lead Study Teams (LST) track the progress of their study sites while they complete the steps in the single IRB (sIRB) review process. These steps require actions from both the site’s study team and their human research protection program (HRPP) or IRB office, all of which are tracked on the Status Summary dashboard. While tracking a site’s progress, CCs and LSTs can use IREx to send reminders to the site PI and coordinators about any remaining steps. IREx also sends notifications to the CC or LST as sites complete the required sIRB steps.

RECRUITMENT INNOVATION CENTER (RIC)

The RIC is currently working to connect research participants and investigators by developing innovative platforms with user friendly interfaces to engage potential participants at the site level. Read more about our newest application, Trials Today, to help facilitate this effort below:

Trials Today Localized

Since its launch in March 2015, Trials Today has facilitated more than 275,000 searches and has been used in all 50 states in the US. Recently, the team increased integration between Trials Today and ResearchMatch, so that volunteers see Trials Today studies of relevance to their self-reported characteristics interest directly within their own dashboard in ResearchMatch. Additional enhancements are also in progress.

Building upon this infrastructure, Trials Today Localized is a Vanderbilt hosted platform that allows partner institutions the ability to quickly adopt a custom branded trial listing service that pulls in clinical trials only related to their institution, providing a simple and easy way for the public to search trials related to their local healthcare institution. Currently, nine institutions have gone live with their own Trials Today Localized instance, and approximately 20 more institutions are in earlier stages of development.

Please contact Douglas Conway if you have questions or if your institution wants to explore use of this tool.

NATIONAL CENTER FOR DATA TO HEALTH (CD2H)

Join the Live CD2H Show & Tell on Friday, July 27 

The CD2H Data Workgroup will showcase projects currently underway at the first ever CD2H Show & Tell. The event is open to all from the CTSA Program community and those who join are encouraged to join the conversation and offer input and feedback. Register now for the Friday, July 27th webinar from 11am to noon PT.

The Latest CD2H News Delivered to You 

Sign up now for the CD2H monthly newsletter to stay up to date with the latest developments from CD2H as we work to support and accelerate collaboration and innovation across the CTSA Program informatics ecosystem. The first CD2H newsletter will be arriving in your inbox in August. Follow the latest from CD2H on Twitter at @data2health for regular updates, news and events.

ANNOUNCEMENTS

RARE DISEASES CLINICAL RESEARCH NETWORK (RDCRN) & DATA MANAGEMENT AND COORDINATING CENTER (DMCC) 

The Office of Rare Diseases Research at NCATS, in partnership with NCI, NIAMS, NIAID, NIDDK, NICHD, NINDS, NIDCR and NHLBI announced two funding opportunities to support collaborative clinical research on rare diseases through the Rare Diseases Clinical Research Consortia (RDCRC) and a Data Management and Coordinating Center (DMCC); both funding opportunities have a deadline of October 9, 2018.

The purpose of the RDCRN is to advance the diagnosis, management, and treatment of rare diseases with a focus on clinical trial readiness. Each RDCRC will promote highly collaborative, multi-site, patient-centric, translational and clinical research with the intent of addressing unmet clinical trial readiness needs.

The DMCC will facilitate and support the activities of each Rare Diseases Clinical Research Consortium (RDCRC) along with trans-network activities that broadly facilitate the advancement of rare disease research via four Cores: 1) Administrative; 2) Data Management; 3) Clinical Research and; 4) Engagement and Dissemination.

FOA Number RDCRN: RFA-TR-18-020
FOA Number DMCC: RFA-TR-18-021

Questions?  Contact Tiina Urv, PhD.

GUIDELINES FOR PRIOR APPROVAL OF PLANNED RESEARCH INVOLVING VERTEBRATE ANIMALS

New studies involving animal subjects that were not reviewed in the competing application must be submitted for prior approval. Requests for prior approval of planned research involving vertebrate animals conducted through NCATS UL1 pilot projects, KL2 scholar projects, and TL1 projects (if the protocol is not covered under the mentor’s grant) must be submitted in writing to NCATS no later than 30 days before the proposed implementation of research involving live vertebrate animals. As part of NIH efforts to comply with 21st Century Cures requirements to enhance accountability and transparency in NIH clinical research, NIH has developed a new Human Subjects System (HSS), which consolidates human subjects and clinical trial information in once place.

CTSA Program Instructions for Submitting Prior Approval Requests for Live Vertebrate Animals Research.

For more information Click Here

Questions? Contact your Program Official

DEVELOPMENT OF MEDICATIONS TO PREVENT AND TREAT OPIOID USE DISORDERS AND OVERDOSE (UG3/UH3)

The purpose of this Funding Opportunity Announcement is to support the discovery and development of medications to prevent and treat opioid use disorders (OUD) and overdose.

Under the Help to End Addiction Long-term (HEAL) Initiative, NIDA has been allocated funds to support medications development to prevent and treat opioid use disorders and overdose. NIDA is currently accepting grant applications for up to $3 million dollars per year (or more with prior NIDA approval) for up to five years under the RFA DA-19-002. This RFA is designed to review and fund grant application in an expedited fashion with a rolling acceptance of applications and expedited review by NIDA Council.

FOA Number: RFA-DA-19-002

Questions?  Contact Dr. Iván Montoya

ADMINISTRATIVE SUPPLEMENTS FOR DOWN SYNDROME

Two new notices have been published for Down Syndrome research. The purpose of NOT-OD-18-194 is to solicit administrative supplement applications to existing awards that are currently NOT focused on Down syndrome research in order to accelerate scientific progress to meet new NIH Down syndrome research objectives (see notice links below).

The purpose of NOT-OD-18-195 is to solicit administrative supplement applications to existing awards that are currently focused on Down syndrome research in order to accelerate scientific progress to meet new NIH Down syndrome research objectives (see notice links below).

Notice Numbers: NOT-OD-18-194; NOT-OD-18-195

Questions?  Contact Erica Rosemond, PhD 

CHANGE IN RECEIPT DATE FOR DIVERSITY AND RE-ENTRY SUPPLEMENTS

Applications may be submitted at any time up to November 1 each calendar year for consideration for funding in the current fiscal year, which always ends on September 30. Applications received after November 1 will be processed and considered for funding in the following fiscal year. Applications will be evaluated, and decisions will be made within two to three months of receipt, but funding decisions can be influenced and delayed by other factors, including the availability of funds. Therefore, potential applicants are advised to consult first with the NCATS program official (PO) assigned to the linked grant and with the relevant NCATS scientific contact prior to submission of a request for a supplement application.

For more information Click Here

Questions?  Contact Erica Rosemond, PhD

NOTICES OF INTENT TO PUBLISH FOAS FOR A CLINICAL TRIALS NETWORK ON PAIN RESEARCH

As part of the HEAL (Helping to End Addiction Long-term) Initiative, NIH will support research on how chronic pain develops and on new treatments to alleviate chronic pain. HEAL will develop a data sharing collaborative, new biomarkers for pain, and a clinical trials network for testing new pain therapies. NINDS has released Notices of Intent to Publish Funding Opportunity Announcements to support a Clinical Trials Network on Pain Research. The notices provide initial information intended to allow potential applicants sufficient time to develop collaborations and project proposals.

Notice Numbers: NOT-NS-18-069; NOT-NS-18-057; NOT-NS-18-058 

Questions?  Contact Jeremy Brown, MD

COLLABORATIVE INNOVATION AWARDS (CCIAs)

NCATS has issued two notices (NOT-TR-18-023 and NOT-TR-18-024) to change the Key Dates in the Collaborative Innovation Award, Clinical and Translational Science Award (CTSA) Program (U01) PAR-18-244 and the Limited Competition: Exploratory CTSA Collaborative Innovation Awards (R21) PAR-18-245.

Questions?  Contact Philip J. Brooks, Ph.D.

NIBIB SUPPLEMENTS TO NCATS CTSA PROGRAMS TO SUPPORT NIBIB TRANSLATIONAL RESEARCH SCHOLARS

The purpose of this administrative supplement is to facilitate translational research partnerships between junior researchers with quantitative backgrounds (in engineering or computational or physical sciences) and junior clinician-scientists from active CTSA Program institutions (PAR-15-304, PAR-18-464).

FOA Number:  PA-18-851

Questions?  Contact Zeynep Erim, Ph.D.

MEETINGS & EVENTS

UPCOMING CONSORTIUM EVENTS

CTSA Program hubs can find information about meetings, events, conferences, and/or items relevant to the CTSA Program and the advancement of translational science on the events page on the CLIC website. If you would like to showcase an event, please fill out the event form (login required) on the CLIC website.

Once you host an event, if you would like your presentations uploaded for viewing on the archived CLIC events page, please submit a PDF version of your event presentations to the email below.

Questions?  Contact help@clic-ctsa.org

UPCOMING NCATS MEETINGS

*CLIC will post meeting summaries from the S/C calls onto the CLIC-CTSA Program websiteand continue to circulate monthly CTSA Program newsletters with important project-level updates and consortium activities.

**To add the PI Meeting to your calendar: Please make sure that once you submit the completed registration form, choose “add to calendar” on the Registration Approval page OR in the Confirmation email that you receive, then open and save the downloaded calendar file.

You can find this or any of the past CTSA Program Updates on the CLIC Newsletters page or on the CTSA Program Communications page.