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February 2021

ISPCTN Communication
As a reminder, a weekly checklist comes out each Monday highlighting action items and brief updates for clinical sites. The ECHO ISPCTN monthly bulletin comes out on the first Tuesday of each month. If you are not currently receiving the weekly checklist email, please notify us at askDCOC@uams.edu.
Welcome Linda Fu, MD
NIH Project Specialist
The DCOC is happy to welcome a new NIH team member to the ECHO ISPCTN family. Dr. Fu has joined the NIH team from Children’s National as a Project Scientist. She will be working with Alan Simon to help the Network develop the ECHO ISPCTN science. Dr. Fu has extensive expertise working with under-represented communities and in vaccine uptake which both align well with many of the things being discussed within ECHO ISPCTN in Cycle 2.
ECHO ISPCTN Steering Committee 
Save the date
February Steering Committee meeting 

Monday, February 8
1:00 p.m.-2:00 p.m. Central/2:00 p.m. - 3:00 p.m. Eastern

You may have noticed a change in your calendar invitation for the February Steering Committee meeting. It was rescheduled from February 1 until February 8 to allow time for review of the next Cycle 2 Expanded Concept Proposal, Virtual visits to Reduce Asthma Morbidity (VRAM).

During the February 8 meeting, you will hear from the four primary reviewers to kick off the Steering Committee review period for this expanded concept proposal. Each site PI will receive an email prior to this meeting with the proposal, primary reviews, and review form.


Save the date
Virtual ECHO ISPCTN Steering Committee meeting
April 6-7, 2021
1:00 - 4:30 Central/2:00 - 5:30 Eastern

The next face-to-face steering committee will be held virtually using Zoom. Please take time to register your team so that the DCOC can adequately plan collaborative activities to include breakout sessions. Volunteers are needed to help plan this important agenda. If interested in participating in this effort, contact Jessica Snowden.

REGISTER YOUR TEAM


Save the date
ECHO ISPCTN Steering Committee meeting
Face-to-face
September 14-15, 2021

The DCOC is planning to host the next face-to-face, in-person ECHO ISPCTN Steering Committee meeting at the Renaissance Arlington Capital View Hotel in Arlington, VA on September 14-15. A calendar invitation will be sent to each clinical site research team this week to hold these dates.

Registration links for team registration and hotel reservations will be shared this summer. Please do not arrange travel or make hotel reservations until the DCOC confirms that this meeting will actually take place in person.


Workshop reminder
Jr. Investigator Workshop
Thursday, February 18
1:00 p.m. - 4:30 p.m. Central/2:00 p.m. - 5:30 p.m. Eastern

The DCOC will be hosting a workshop for Jr. Investigators on Thursday, February 18. Topics include writing in response to a specific RFA; designing an answerable research question; aligning your specific aims, objectives, approach, and outcomes; and a panel discussion of pilots versus multicenter trials.

If you plan to attend and do not show the workshop information on your calendar, please register and the information will be sent to you. REGISTER


ECHO ISPCTN Speakers Bureau
Action Requested

As part of the ECHO ISPCTN Branding Working Group efforts, the DCOC is updating the Speakers Bureau that will be part of the “ISPCTN Branding Toolkit”. This speakers list is an important piece of the capacity building initiative for the Network. It will create great opportunities for junior faculty to present throughout the country and for all to amplify the presence of ECHO ISPCTN.

SPEAKERS BUREAU SIGN UP
Funding Opportunities
HEAL Initiative Funding Opportunities
HEAL Initiative: Data Coordinating Center for the Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial (U24) – Data Coordinating Center
https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-21-032.html
 
HEAL Initiative: Neonatal Opioid Withdrawal Syndrome Pharmacological Treatments Comparative Effectiveness Trial - Clinical Sites (UG1) – Clinical Centers
https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-21-031.html
Trial Updates

Study enrollment update
VDORA1 Part 2 is approaching the randomization limit of 63 randomized participants. All 17 VDORA1 sites have enrolled at least one participant. Currently, there are 86 participants enrolled, 61 randomized and 1 in the run-in phase of the study. Additional potential participant screenings must be approved by VDORA1 Project Lead Kimberly Harris (krharris@uams.edu) prior to scheduling a screening visit.  

VDORA1 Healthy Heroes 2021 Calendars were sent to each site to gift to research participants and caregivers. Participant contest winners will receive a special certificate and gift card for participating. To view the 2021 calendar click HERE.

STUDY UPDATE

Please continue to send all study questions to AskVDORA@uams.edu.

Post-intervention Phase
The iAmHealthy feasibility study will enter the post-intervention phase next week, which will run from February 8 to March 7. Of the 104 participants randomized, 99 will enter the post-intervention phase. The goal is that 75% of these participants will remain active through the post-intervention measurements.
 
All sites can start scheduling height and weight measurement appointments and shipping activity monitors. When talking to participants, please remind them that you are blinded and that the Dietetics and Nutrition Team is blinded. The Dietetics and Nutrition Team will begin contacting participants the week of February 8 to schedule the post-intervention 24-hour food recall.

For all questions regarding iAmHealthy, contact DeAnn Hubberd at DEHubberd@uams.edu
ACT NOW Current Experience Paper Review
The ECHO ISPCTN ACT NOW CE Variations paper, published in Pediatrics in December 2020, was highlighted in a Reuters article on Medscape and other sources on January 12, 2021. We’ve uploaded the PDF into the portal and also have the link here:  Site-to-Site Variation, Lack of Optimal Care for Neonatal Opioid Withdrawal (medscape.com)

Congratulations to the ACT NOW CE study team for publishing a high impact paper that continues to receive attention!
ECHO ISPCTN Publications
To access the latest ECHO ISPCTN Publications updates, click here:
PUBLICATIONS STATUS TABLE
To access the ECHO ISPCTN Manuscripts Author Roster, click here:
MANUSCRIPTS AUTHOR ROSTER
Professional Development
NIMHD Director's Seminar Series
Thursday, February 4
2:00 p.m. Eastern

“Where the Cloud Meets the Ground: Democratizing Health Data to Improve Community Health Equity” from L. Ebony Boulware, MD, MPH.  This lecture will be held virtually and can be viewed HERE
Detailed seminar information can be found at Director’s Seminar Series 


Summer Institute on Randomized Behavioral Clinical Trials
July 23, - August 1, 2021
Application deadline: February 15, 2021

The NIH Office of Behavioral and Social Sciences Research (OBSSR), in collaboration with the National Heart, Lung, and Blood Institute (NHLBI), will hold the 21st annual Summer Institute on Randomized Behavioral Clinical Trials from July 23 – August 1, 2021. The Institute will be held at the Bolger Center in Potomac, Maryland if possible, but it will be held virtually instead if the COVID-19 pandemic prevents us from meeting in person.
 
APPLICATION

NINDS Clinical Trials Methodology Course
Application deadline: February 28

The NINDS Clinical Trials Methodology Course (CTMC) is accepting applications for the 2021 cohort (virtual). The overarching goal of the CTMC is to help investigators develop scientifically rigorous, yet practical clinical trial protocols.

APPLICATION

The application submission deadline is February 28, 2021 at midnight, Pacific Time.  
Contact NINDS‐CTMC‐Info@umich.edu or William Meurer, MD, MS with any questions.  


MAGI's Spring 2021 Conference
April 26 - May 6, 2021
10:00 a.m. - 4:00 p.m. Central/11:00 a.m. - 5:00 p.m. Eastern

The conference will be fully virtual covering many topics of interest to research team members at all levels through 80+ session and eight tracks: clinical operations & project management, quality & risk management; site management; contracts; budgets & billing; regulatory compliance; management & professional skills; working; and special topics. Session recordings will be available during the conference and for the following two weeks.

REGISTER HERE


The Road to Approval of a COVID-19 Vaccine by the FDA
Presented by: Jeannette Lee, PhD 
Professor of Biostatistics UAMS
Principal Investigator for the ECHO ISPCTN DCOC
Temporary Voting Member of the Vaccine and Related Biological Products Advisory Committee of the FDA


PRESENTATION

Please feel free to share any and all professional development opportunities hosted by your institution that you feel might benefit members of the ECHO ISPCTN and help build research capacity. Send this information to AskDCOC@uams.edu.
Share the Good News from your Site!
If you have good news that you would like to share in the ECHO ISPCTN Monthly Bulletin please email AskDCOC@uams.edu
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