Steering Committee Pods

Overview

CTSA Program Pods are designed to facilitate bidirectional communication between NCATS and the CTSA Program Steering Committee (SC), collectively “CTSA Program leadership,” and the local CTSA Program hubs.

A “Pod” is a subgroup of CTSA hub PIs that is led by a current member of the CTSA Steering Committee who is designated the “Pod Lead.” Pods meet regularly to review updates from the SC, discuss issues raised by the local hubs, and provide an opportunity for the CTSA community to raise other topics to CTSA Program leadership through Pod Submissions.

Please view the Pod Assignments for the current Pod structure and the Pod Quick Reference Guide for more information about Pod activities.

Pod Submissions

The Pod Submission Form is one of the main channels for Pod communication with CTSA Program leadership. Following each Pod meeting, the Pod Lead submits meeting notes and any feedback or questions raised by Pod members.

Pod submissions are posted on the CLIC website and are reviewed by the Steering Committee on a monthly basis. Where applicable, Pod submissions may be appended to reference meeting notes, webinars, or other communications relevant to the submitted feedback.

For detailed information on how to submit Pod feedback, please refer to the Pod Submissions SOP.

Please note: Pods formerly submitted reports through the CLIC Suggestion Box. This communication channel is still open for general feedback from the CTSA community. All Pod-related submissions should now be submitted through the form linked on this page.


 

Pod Submissions

Pod Meeting Date

January 24, 2022

Pod Lead

Olveen Carrasquillo

Summary Report

Yes

Feedback

No

Form Submission Date: February 28, 2022

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Date

January 26, 2022

Pod Lead

Duane Mitchell

Summary Report

Yes

Feedback

No

Form Submission Date: March 02, 2022

Pod Meeting Summary Report

Summary Report: Our CTSA Pod discussed meeting format and objectives going forward and agreed upon continued monthly engagement with updates on CTSA Steering Committee information and prospectively planned discussion forums to exchange information, ideas, and best practices amongst the Pod Hubs. Dissemination of the SC slides and minutes accessible through the CLIC website to Pod members ahead of the meeting for discussion was deemed useful and a Microsoft Teams group for the CTSA Pod was established for materials generated during Pod meeting and/or discussed to be archived. A discussion on the new CTSA UM1, K12, and T32 grants was held and some expressed concern that the changes to the grant mechanism would negatively impact the current number of KL and TL scholars supported at some CTSA Hubs. It was felt that querying our Pod sites for the impact of the changes on supported scholars would be useful to tabulate and communicate to the steering committee. UF-FSU Hub has collected information from the sites for discussion at subsequent Pod meeting and then submission of information to the steering committee and NCATS for feedback. Topics for future Pod meetings will be selected to allow for invitation of other members from the CTSAs that may contribute to discussion and/or benefit from being included in the information disseminated at the Pod meeting.

Pod Meeting Date

February 22, 2022

Pod Lead

Olveen Carrasquillo

Summary Report

Yes

Feedback

Yes

Form Submission Date: February 28, 2022

Pod Meeting Summary Report

Summary Report File:

Feedback - Idea Sharing

Idea Sharing Feedback: Suggestions from the Pod:
• Central repository of survey results for CTSAs to be able to access
• Central repository of Working Group products/outcomes
• Central repository of CTSA products/outcomes/findings – for other CTSAs to leverage and fulfill promise of consortium; hard to know who to reach out to when a CTSA is tackling a problem; instead of reinventing the wheel, better to reach out to peers – but how to find?
• How to join working groups? Solicitations for participants are not sent out; “how to” join these groups is an opaque process
• “Key words” or indexing of discussion forums or some other way to search through them; very helpful information that is not easy to sift through
• Branding is an issue. With no standard branding, it is hard for others to identify when a CTSA has been involved in an outcome/solution; people don’t know what the CTSAs have done.

Pod Meeting Date

February 28, 2022

Pod Lead

Ruth O'Hara

Summary Report

No

Feedback

Yes

Form Submission Date: March 14, 2022

Feedback - Response to Request for Information

Request for Information Response: Here is the feedback from the Stanford Hub in response to a request for information

Q1: April 22 In-Person SC Meeting Topics

How we are defining the Science of Translation?
Discussion of the expanding role of community engagement in CTSAs.
How to enhance and collaborate around DEI efforts.
Discussion of the vision for informatics across CTSAs.

Feedback -

Request for Information Response:

Pod Meeting Date

March 02, 2022

Pod Lead

David McPherson

Summary Report

No

Feedback

Yes

Form Submission Date: March 11, 2022

Feedback - Question

Question: What is the role of the TINs going forward? Further guidance more than 1 line in FOA

Would you like a response from NCATS? Yes

Pod Meeting Date

March 09, 2022

Pod Lead

Muredach Reilly

Summary Report

Yes

Feedback

Yes

Form Submission Date: March 14, 2022

Pod Meeting Summary Report

Summary Report: ○ Date of Pod Meeting: 3/9/2022, 11:00am
○ Pod Lead Name: Muredach Reilly
○ Pod meeting summary:
§ The Pod led by Muredach Reilly at Columbia University's CTSA Program hub met on Wednesday, March 9, 2022.

The Pod discussed the following:
1) New CTSA FOA
1) The Pod reviewed and shared challenges in responding to new CTSA UM1 FOA focused on clinical and translational science concepts. The Pod is interested in hearing from others on their writing challenges and lessons learned in real-time.
2) The Pod would like the Steering Committee to address the need for more discussion about the disruption that CTSA hubs who are applying to the first due date of the new FOA are experiencing. This includes the potential for bridge funding and if there will be any further changes to the FOA or due dates.
3) This will also be submitted as a question to the Steering Committee.

2) Consortium governance structures
1) The Pod discussed how different governance models for the CTSA Program may improve integration across the consortium. The Enterprise Committees and Working Groups are often siloed and not fully integrated across the consortium and more effective models should be considered.
2) This will also be submitted as an idea sharing with the Steering Committee.

3) DEI Task Force
1) The DEI task force should remain consortium-wide and not become an Enterprise Committee or Working Group.
2) This will also be submitted as an idea sharing with the Steering Committee.

4) Discussion on common cross-consortium ideas
1) Education and training is one common cross-consortium idea that the Pod universally thought that all hubs will strongly support. Developing a consortium-wide mechanism to share materials and best practices in education and training is needed.
2) The Pod discussed other common cross-consortium ideas including the development of maturity models for DEI, clinical trials, and informatics and data harmonization.
3) This will also be submitted as an idea sharing with the Steering Committee.

5) Fall Program meeting
1) The Pod discussed the Fall Program meeting and identified the following themes:
1) Common consortium initiatives and ideas including education and training, and aspects of DEI
2) Discussion about what will replace CLIC and CD2H and the transition plan, including what do hubs and the consortium need and want in those areas
3) New models for bottom-up and top-down consortium initiatives, ideas and efforts
2) The Pod identified the following dates to avoid:
1) October 19-23 (Infectious Disease), November 1-6 (Kidney), November 5-7 (AHA)
3) This will also be submitted as a response to request for information to the Steering Committee.

Feedback - Question

Question: 1) New CTSA FOA
1) The Pod reviewed and shared challenges in responding to new CTSA UM1 FOA focused on clinical and translational science concepts. The Pod is interested in hearing from others on their writing challenges and lessons learned in real-time.
2) The Pod would like the Steering Committee to address the need for more discussion about the disruption that CTSA hubs who are applying to the first due date of the new FOA are experiencing. This includes the potential for bridge funding and if there will be any further changes to the FOA or due dates.

Would you like a response from NCATS? Yes

Feedback - Idea Sharing

Idea Sharing Feedback: Consortium governance structures: The Pod discussed how different governance models for the CTSA Program may improve integration across the consortium. The Enterprise Committees and Working Groups are often siloed and not fully integrated across the consortium and more effective models should be considered.

Feedback - Idea Sharing

Idea Sharing Feedback: DEI Task Force: The DEI task force should remain consortium-wide and not become an Enterprise Committee or Working Group.

Feedback - Idea Sharing

Idea Sharing Feedback: Discussion on common cross-consortium ideas: Education and training is one common cross-consortium idea that the Pod universally thought that all hubs will strongly support. Developing a consortium-wide mechanism to share materials and best practices in education and training is needed. The Pod discussed other common cross-consortium ideas including the development of maturity models for DEI, clinical trials, and informatics and data harmonization.

Feedback - Response to Request for Information

Request for Information Response: Fall Program meeting
1) The Pod discussed the Fall Program meeting and identified the following themes: Common consortium initiatives and ideas including education and training, and aspects of DEI; Discussion about what will replace CLIC and CD2H and the transition plan, including what do hubs and the consortium need and want in those areas; New models for bottom-up and top-down consortium initiatives, ideas and efforts
2) The Pod identified the following dates to avoid: October 19-23 (Infectious Disease), November 1-6 (Kidney), November 5-7 (AHA)

Pod Meeting Date

March 13, 2022

Pod Lead

Cynthia Morris

Summary Report

Yes

Feedback

No

Form Submission Date: March 14, 2022

Pod Meeting Summary Report

Summary Report: I was at study section that day and asked for a report (attached).

Summary Report File:

Pod Meeting Date

March 21, 2022

Pod Lead

Robert Kimberly

Summary Report

Yes

Feedback

No

Form Submission Date: March 24, 2022

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Date

March 22, 2022

Pod Lead

Olveen Carrasquillo/ University of Miami

Summary Report

Yes

Feedback

No

Form Submission Date: March 23, 2022

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Date

March 22, 2022

Pod Lead

Karen Johnston

Summary Report

Yes

Feedback

Yes

Form Submission Date: March 22, 2022

Pod Meeting Summary Report

Summary Report: 1. Big picture concepts that the CTSA consortium should tackle: a.) study start-up efficiencies (SMART IRB and SMART contracts - revisit and improve as needed); b) harmonization of big data - next steps (ACT/N3C - large harmonized datasets - what have we learned?; c) siteless clinical trials - recruiting/data capture straight from the community; d) follow up on TIN/RIC/TIC - next steps for support of multi-center clinical trials for the consortium
2. Nomination of Michael Holinstat, PhD (University of Michigan) for the planning committee for the CTSA Fall meeting
3. Our POD expressed desire to hear more feedback about the overall impact (not just anecdotal stories) about the CTSA wide programs and initiatives (such as TIN, SMART IRB, N3C, ACT, etc). Can we see investment and impact data?

Feedback - Question

Question: Our POD expressed desire to hear more feedback about the overall impact (not just anecdotal stories) about the CTSA wide programs and initiatives (such as TIN, SMART IRB, N3C, ACT, etc). Can we see investment and impact data?

Would you like a response from NCATS? Yes

Pod Meeting Date

April 05, 2022

Pod Lead

Muredach Reilly

Summary Report

Yes

Feedback

Yes

Form Submission Date: April 11, 2022

Pod Meeting Summary Report

Summary Report: o The Pod led by Muredach Reilly at Columbia University's CTSA Program hub met on Tuesday, April 5, 2022. The Pod discussed the following:
o CTSA FOA budget changes [idea sharing and request for response]
 Within the Pod, one of the hubs was very negatively impacted by the new FOA budget tier structure. This hub is a small sized hub that serves a largely minority population. This disruption and the funding budget process overall requires more discussion with NCATS on how the tiers are determined. The Pod strongly supports further revision and improvement of the funding tiers and CTSA program funding.
o Advancing clinical research [idea sharing]
 In context of NIH and NCATS transitions and deficiencies in CTS infrastructure exposed by COVID-19 pandemic, the Pod discussed opportunities for improved national models of CTS infrastructure, collaboration, innovation, communication and governance – and the need for dialog between NIH/NCATS and CTSA hub institutions and the CTSA network on these issues.
 Further, this dialog should engage the deans and senior leaders at each CTSA institution to become part of a larger discussion (e.g., with NAM, AACP, NIH etc) to reimage the national clinical and translational research mission and infrastructure.
o Open meeting of NCATS leadership and CTSA PIs [request for response]
 The Pod discussed the commitments made by NCATS to engage in an open dialog between NCATS leadership and CTSA PIs on addressing challenges and concerns of CTSA hub institutions and leaders. The Pod members are interested in such a meeting, particularly if it has an open constructive agenda, and would be willing to travel to attend in person. The Pod requests a response from NCATS on when such meetings will be held, e.g., at the upcoming spring CTSA Program meeting April 22-23 and also at the fall meeting.
o NCATS CTSA goals [request for response]
 The Pod noted that the CTSA Program goals were updated on the NCATS website to reflect the new RFA/FOA. However, this was not widely communicated to the CTSA consortium or discussed at the steering committee level. The Pod requests a response from NCATS as to whether there will be a broader discussion about these goal changes.

Feedback - Response to Request for Information

Request for Information Response: o CTSA FOA budget changes
 Within the Pod, one of the hubs was very negatively impacted by the new FOA budget tier structure. This hub is a small sized hub that serves a largely minority population. This disruption and the funding budget process overall requires more discussion with NCATS on how the tiers are determined. The Pod strongly supports further revision and improvement of the funding tiers and CTSA program funding.

Feedback - Idea Sharing

Idea Sharing Feedback: o Advancing clinical research
 In context of NIH and NCATS transitions and deficiencies in CTS infrastructure exposed by COVID-19 pandemic, the Pod discussed opportunities for improved national models of CTS infrastructure, collaboration, innovation, communication and governance – and the need for dialog between NIH/NCATS and CTSA hub institutions and the CTSA network on these issues.
 Further, this dialog should engage the deans and senior leaders at each CTSA institution to become part of a larger discussion (e.g., with NAM, AACP, NIH etc) to reimage the national clinical and translational research mission and infrastructure.

Feedback - Response to Request for Information

Request for Information Response: o Open meeting of NCATS leadership and CTSA PIs
 The Pod discussed the commitments made by NCATS to engage in an open dialog between NCATS leadership and CTSA PIs on addressing challenges and concerns of CTSA hub institutions and leaders. The Pod members are interested in such a meeting, particularly if it has an open constructive agenda, and would be willing to travel to attend in person. The Pod requests a response from NCATS on when such meetings will be held, e.g., at the upcoming spring CTSA Program meeting April 22-23 and also at the fall meeting.

Feedback - Response to Request for Information

Request for Information Response: o NCATS CTSA goals
 The Pod noted that the CTSA Program goals were updated on the NCATS website to reflect the new RFA/FOA. However, this was not widely communicated to the CTSA consortium or discussed at the steering committee level. The Pod requests a response from NCATS as to whether there will be a broader discussion about these goal changes.

Pod Meeting Date

April 11, 2022

Pod Lead

Cynthia Morris

Summary Report

Yes

Feedback

No

Form Submission Date: April 18, 2022

Pod Meeting Summary Report

Summary Report: We had sparse attendance due to travel. There were three important points raised in discussion.
1. ECs in general are seen as an excellent way to for community within the consortium. However it was questioned if they are driving any new actions. There was some disagreement noted as some ECs have very different objectives. As an example, workforce EC prioritizes sharing innovative solutions among the consortium and less so common initiatives. However there have been 2 collaborative NIH grants and 3 active work groups generated in the past 5 years. Informatics EC prioritizes creating innovative solutions collaboratively and have work groups to carry out the effort.
2. Entire cohort moves slowly and deliberately.....adoption of sIRB, QI/QC. Working groups could be a place to grow those ideas although not all groups have done it effectively. THis will be very hard post-CLIC which has done an excellent job promoting activities such as Insight to Inspire. Keeping a way to grow consortium efforts is of prime importance but is difficult as we do not really assemble as PI cohort with discussion and subsequent action.
3. Finally, there was emphasis from two sites in the cohort about the prime importance of building and maintaining trust of the hubs with the SC, as well as hub and NCATS. Two examples were cited. For any upcoming special JCTS issue, open this to the consortium for contribution, including the potential for new ideas, not ideas filtered through the SC or a select group of editors formed from the SC. The process for the COVID issue still leaves a bad taste for some hub members who felt left out. The second example focused on the fall meeting and greater opportunities to assemble, discuss as a consortium.
3.
2.

Pod Meeting Date

April 25, 2022

Pod Lead

Don McClain

Summary Report

Yes

Feedback

Yes

Form Submission Date: May 06, 2022

Pod Meeting Summary Report

Summary Report: -Pod Call on 4/25 spent the majority of the time discussing the structure of working groups and the data that was presented at the Steering Committee (feedback shared in section below)
-additional time spent planning an invite for Dr. Mike Kurilla to join a future pod call; currently discussing topics that would be most valuable for when he is present and will reach out shortly

Feedback - Response to Request for Information

Request for Information Response: The below points are responses to how working groups could be improved:
-we should let the working groups mature more, and make sure they are the appropriate size to see what they can accomplish; these things take time
-should the work groups that are supposed to be carved out for the "big problems" be classified as something distinct - our recommendation "Task Force"
-Task Force could be given a certain timeline to bring results/ideas back to the steering committee
-Task Force should include administrators and evaluators (not just PIs)
-Task Force should ben solution oriented (instead of problem oriented)

Pod Meeting Date

April 26, 2022

Pod Lead

Olveen Carrasquillo/ University of Miami

Summary Report

Yes

Feedback

No

Form Submission Date: May 24, 2022

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Date

May 02, 2022

Pod Lead

Larry Sinoway

Summary Report

Yes

Feedback

No

Form Submission Date: May 05, 2022

Pod Meeting Summary Report

Summary Report: We met a week or so after the steering committee meeting. We discussed work groups-most felt they had value. Feeling was there needed to be support for these activities. This led into discussion of CLIC. Group felt that CLIC was an asset to the HUBS. Feeling was that CLIC was responsive. Specific attributes were discussed. Discussion then move to the transition to what will replace CLIC. Concerns raised that there was not a firm plan in place for CLIC replacement organization. Many felt it would be very helpful if the HUB leadership or the steering committee were able to voice their thoughts on how the new CLIC could help them advance their local and national missions.

Pod Meeting Date

May 06, 2022

Pod Lead

Muredach Reilly

Summary Report

Yes

Feedback

Yes

Form Submission Date: May 10, 2022

Pod Meeting Summary Report

Summary Report: ○ Date of Pod Meeting: 5/6/2022, 3:00pm
○ Pod Lead Name: Muredach Reilly
○ Pod meeting summary:
§ The Pod led by Muredach Reilly at Columbia University's CTSA Program hub met on Friday, May 6, 2022. The Pod discussed the following:
§ Revised CTSA goals [request for response from NCATS]
□ The Pod seeks clarification from NCATS on the revised CTSA goals and specifically whether the new goals will used as criteria to judge CTSA grant submissions. The Pod requests further advisement on goal #5, to "provide a national resource for the rapid response to urgent public health needs", in addition to general advisement on the meaning of the new goals.
§ Common CTSA goals [idea sharing]
□ The Pod continues to suggest that the consortium develops common goals across all CTSAs over the next several years including potential areas such as: a national education curriculum; innovation in the clinical trials infrastructure and networks; integration across CTSAs for a rapid response initiative to address public health crises (e.g. pandemics); and diversity, equity and inclusion (DEI) programs.
§ Invite to Dr. Kurilla to attend future Pod meeting [request for response from NCATS]
□ The Pod would like to invite Dr. Kurilla to attend a future meeting in Summer 2022. Please let us know how and when to proceed with scheduling.
§ Collaborative discussion with NCATS [idea sharing]
□ The Pod seeks continued collaborative and bi-directional discussions with the PI's, Pods, and NCATS about the new CTSA FOA and continued revisions to the FOA.

Feedback - Response to Request for Information

Request for Information Response: Revised CTSA goals: The Pod seeks clarification from NCATS on the revised CTSA goals and specifically whether the new goals will used as criteria to judge CTSA grant submissions. The Pod requests further advisement on goal #5, to "provide a national resource for the rapid response to urgent public health needs", in addition to general advisement on the meaning of the new goals.

Feedback - Idea Sharing

Idea Sharing Feedback: Common CTSA goals: The Pod continues to suggest that the consortium develops common goals across all CTSAs over the next several years including potential areas such as: a national education curriculum; innovation in the clinical trials infrastructure and networks; integration across CTSAs for a rapid response initiative to address public health crises (e.g. pandemics); and diversity, equity and inclusion (DEI) programs.

Feedback - Response to Request for Information

Request for Information Response: Invite to Dr. Kurilla to attend future Pod meeting: The Pod would like to invite Dr. Kurilla to attend a future meeting in Summer 2022. Please let us know how and when to proceed with scheduling.

Feedback - Idea Sharing

Idea Sharing Feedback: Collaborative discussion with NCATS: The Pod seeks continued collaborative and bi-directional discussions with the PI's, Pods, and NCATS about the new CTSA FOA and continued revisions to the FOA.

Pod Meeting Date

May 16, 2022

Pod Lead

Bob Kimberly

Summary Report

Yes

Feedback

No

Form Submission Date: May 20, 2022

Pod Meeting Summary Report

Summary Report: CTSA POD Call
Monday, May 16, 2022

Attachments:
• CTSA SC Meeting 20220509 Slides
• CTSA SC Meeting 20220422 Slides
• DEI Task Force Report
NCATS Updates
 NCATS has undergone a reorganization, leading to a new Division for Rare Diseases, 2 new Branches and 2 new sections under DCI https://ncats.nih.gov/about/center/proposed-reorganization
• Erica Rosemond will lead the CTSA Program Branch
• Salina Waddy (new hire) will lead the Clinical Affairs Branch, which will oversee programs like the TIN, TIC, RIC
• Christopher Hartshorn (new hire) will lead the Digital & Mobile Technologies Section
• Mercedes Rubio (new hire) will lead the Education & Training Section
 DCI has similarly experienced tremendous growth since 2020, including 16 new hires in various positions, doubling the staff leadership

ACTION:
• Bob Kimberly to reach out to Mike Kurilla to invite him to our June Pod call, which will be rescheduled respectful of Juneteenth
• Bob Kimberly will connect with other SC members who have previously hosted Mike Kurilla at a Pod call to understand their approach to structure and content
• The Pod welcomed greater insight to the impact of NCATS staff growth relative to the Center’s overall budget
• The Pod was eager to better understand the nature, job scope and charge of the structures and new hires, which could be an agenda topic for Mike Kurilla’s Pod visit
• The Pod expressed enthusiasm for greater transparency of the integrative strategy between NCATS Divisions (DCI, pre-CI, etc.) and accessibility to the expertise and capacity in the Preclinical Innovation Division by CTSAs
DEI Task Force
 There continues to be enthusiasm for the recommendations of the DEI Task Force
 The Pod underscored the importance of considering the resource needs to implement such strategies

ACTION:
• The DEI Task Force Report is attached for reference
Informative Clinical Trials
 Recognition of the work of the RIC in clinical trial recommendations
• RIC Publication: Cook, S., … Harris P. (2022). What we wish every investigator knew - Top 4 recruitment and retention recommendations from the Recruitment Innovation Center. Journal of Clinical and Translational Science, 1-12.
 With continued reference to a draft NASEM report, the Pod continued its discussion of clinical trial site standards.
 The Pod considered the “High Level Discussion Guide” set forth in the May 9 2022 SC slide deck (slide 8)
• The group acknowledged that one size does not fit all and that general “guidelines/best practices” might be helpful to define a shared vision that could then be considered within local context
 Absent more specific detail of such guidelines, the concept is hard to interpret
• Concern that guidelines often fall short of implementation recommendations (the “how”) and may not generalize
 Similar concern that implementation could require major expansion of scope and workforce
• Inter-CTSA collaborations represent a good place for collaboration toward uptake and refinement

ACTION
• The Pod encouraged conversation that engages broad perspectives of the CTSA Consortium (e.g., via Un-Meeting) to inform such guidelines



Pod Meeting Date

May 24, 2022

Pod Lead

Olveen Carrasquillo/ University of Miami

Summary Report

Yes

Feedback

Yes

Form Submission Date: May 24, 2022

Pod Meeting Summary Report

Summary Report File:

Feedback - Idea Sharing

Idea Sharing Feedback: General Discussion and Comments
• Funding decision turnaround times at NCATS are very challenging; very hard to stop operations quickly
• Considering different pools of CTSA submission cohorts in same pool for funding decisions is not a sound methodology