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March 2020 

REMINDER
Welcome to the first "Monthly Bulletin" from the DCOC.
As a reminder, we are piloting a weekly checklist that comes out on Friday highlighting action items and brief updates.
The monthly bulletin will come out on the second Tuesday of each month.
Important Message

from the DCOC
Coronavirus and ECHO ISPCTN activities
We are monitoring the evolving coronavirus (COVID-19) situation and its potential impact on ECHO ISPCTN activities, such as clinical trial activities and face-to-face meetings. The DCOC will update the contact Principal Investigator at each site as soon as possible via email with any changes in procedures, scheduling, or other ECHO ISPCTN activities.

Currently, the DCOC is planning to continue the planned iAmHealthy interventionist meeting in Atlanta as scheduled and will have remote access options available via GoToMeeting for attendees who are unable to travel to the meeting. We are currently proceeding with plans for the May Face-to-Face Steering Committee meeting as usual and will include remote viewing options for that meeting as well. We encourage you to work with your local institution to identify any guidelines for clinical trial activities in the setting of a respiratory pandemic and notify your DCOC site manager if you have any anticipated disruptions. Please contact Jessica Snowden (jsnowden@uams.edu) with any questions or concerns.  
ECHO ISPCTN

Steering Committee 
ECHO ISPCTN Return of Summary Results Policy
The ECHO ISCPTN Steering Committee has approved the ECHO ISPCTN Return of Summary Research Results Policy.  Thank you to the ECHO ISPCTN Stakeholder Working Group for their work on this policy.

The approved policy can be found HERE.

ACTION REQUESTED
Review and score proposals
Deadline March 20 
Steering Committee reviews and scores for the 16 brief concept proposals are due by the end of the day Friday, March 20. If you need the proposals, link to the score sheet, or scoring instructions, please email Jessica Snowden (jsnowden@uams.edu).
 
ECHO ISPCTN Steering Committee face-to-face meeting
Save the Date & Register

May 12-13, 2020
The DCOC has begun planning the next face-to-face Steering Committee Meeting scheduled for May 12-13 in Arlington, VA. Deadline to register and make your hotel reservation is Monday, April 13.

Meeting registration:
REGISTER

Hotel reservations:
RESERVATIONS
Funding Opportunity
Funding Opportunity for sites with INBRE, COBRE or IDeA-CTR grants
GRANT APPLICATION
Trial Updates

ACTION REQUESTED
At the recent VDORA1 Investigator Meeting, sites were asked to provide information about local practices regarding research in the setting of pandemic. Please provide your institutional plans for COVID 19 to the DCOC as soon as possible via email at AskVDORA@uams.edu.

VDORA1 Study Update

During part 1 of the VDORA1 Study, participants were randomized to one of four dosing regimens of vitamin D:
  • Cohort 1 – Single 50,000 IU loading dose +   6,000 IU daily
  • Cohort 2 – Single 50,000 IU loading dose + 10,000 IU daily
  • Cohort 3 – 6,000 IU daily
  • Cohort 4 – 600 IU daily
The DCOC submitted data from part 1 to the pharmacokinetic analysis team at Duke in November 2019.  The pharmacokinetic analysis team released the analytic report to the VDORA1 study team on January 29, 2020.  Based on their review of the report, the VDORA1 study team proposed that the dosing regimen that consisted of a single 50,000 IU loading dose + 8,000 IU daily be used for part 2. 

The ECHO ISPCTN Data Safety and Monitoring Board (DSMB) met on February 13, 2020 to review the recommended dose along with a data report prepared by the DCOC.  The DSMB approved of the recommended dose.  We are proposing the following dose for VDORA1 part 2, pending central IRB approval. 
  • Cohort A – Single 50,000 IU loading dose +   8,000 IU daily
  • Cohort B – 600 IU daily
VDORA1 TIMELINE - CLICK HERE

Enrollment and randomization
As of Thursday, March 5, iAmHealthy participating sites have enrolled 25 participants, with South Carolina enrolling the most participants. The goal is 28 participants/clinic during the 10 weeks of recruitment (eight weeks regular recruitment; two-week catch-up recruitment).

The DCOC biostatistical team randomized the four sites into one of two recruitment options (Consecutive and Traditional). Sites recruited using their assigned recruitment option for four weeks and then switched to the other recruitment option to recruit for another four weeks. Sites switched recruitment options on Monday, March 2, and are in the sixth week of recruitment. At the end of the eight-week recruitment period, sites will have a two-week recruitment catch-up period where they can enroll using their most successful recruitment option. Recruitment is behind the pace needed to meet the study’s enrollment goal, but during the week of February 26-March 5, iAmHealthy sites enrolled 10 participants!

Thanks to our hard-working teams in Delaware, Nebraska, South Carolina, and West Virginia for their dedication to the study.
ECHO ISPCTN Publications
To access the latest ECHO ISPCTN Publications updates, click here:
PUBLICATIONS STATUS TABLE
Professional Development Opportunities
Tackling Informed Consent 
Under the Single IRB Model
SAVE THE DATE

Wednesday, March 18, 2020
2:00 - 3:30 p.m. ET/1:00 - 2:30 CT/12:00 - 1:30 MT/11:00 a.m. - 12:00 p.m. PT
REGISTER HERE


NIH Workshop:
Developing and Validating Metrics and Measures for Stakeholder Engagement in Research

SAVE THE DATE

Wednesday, March 25, 2020
11:00 a.m. ET
REGISTER HERE
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