Steering Committee Pods

Pod Meeting Summary Report

Summary Report File:

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 Summary Report

Summary Report File:

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.

Pod Meeting Summary Report

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

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Pod Meeting Summary Report

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Pod Meeting Summary Report

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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?

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.

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 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

Pod Meeting Summary Report

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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 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.

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 Summary Report

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Pod Meeting Summary Report

Summary Report: Dr. Kurilla attended this Pod meeting session. The meeting discussion focused on three main areas:
• CTSA FOA and funding: The Pod continues to advocate for collaborative communication around the CTSA FOA. The Pod is particularly concerned about the nuance between "translational science" and "translational research" and suggests that more education be provided to the PI's, CTSA Program hubs, and the reviewers to ensure adequate working knowledge. The Pod also advocated for clearer language in FOA regarding institutional commitments. Finally, the Pod advocated for clear criteria and transparent policy on cost extensions and for 100% coverage during such extensions when criteria are met.
• Common CTSA goals: The Pod continues to encourage NCATS to consider different models for communication and collaboration (looking at others including CDC networks) and establishment of cross-cutting goals that can enable the consortium and NCATS to collaborate and be seen as a leader during a time of disruption including the appointment of a new Director of NIH, ARPA-H, clinical trials re-inventions and diversity and equity in clinical research .
• Building trust and increasing opportunities for communication: The Pod supports NCATS in continuing to create more open frameworks for discussion and collaboration and to engage in open discussion and provide evidence whenever possible to validate the rationale for decisions that impact the consortium (e.g., new CTSA goals, pivot to translational science priorities, funding tiers and cost extensions, and launching/containing initiatives like TIN and N3C etc.).

Pod Meeting Summary Report

Summary Report: Meeting Summary Report:
1. NYU hub presented a research opportunity from a CTSA supplement for their hub for the pod to consider. RFA distributed to pod.
2. Discussed the TL1 William Schnaper Visiting Scientist Program
3. Reminded team to send visually compelling images to NCATS
4. CTSA Fall meeting reminders for hub - themes discussed
5. Planning for Mike Kurilla to join our pod meeting in July
6. Discussion of topics for new potential Working Groups:
- Generalizable roadblocks in translational science
- Next phase of work to improve study start-up
- Data harmonization across electronic health records

Pod Meeting Summary Report

Summary Report: • Announcements/updates/reminders
o CTSA Fall meeting – Nov 1-2, 2022 – Reminder that Karen Johnston & Tesheia Johnson from our pod are on the planning committee!
 Theme: Achieving health equity through the science of translation
 Poster session theme: Achieving health equity through the science of translation
 Registration is now open on the CLIC site!
o DEIA survey is due from all sites on Aug 29
o Please see attached the CCTS letter to NCATS re new FOA and the compiled comments from sites who shared feedback after the first cycle submissions. PLEASE review and bring your comments/questions to our August meeting!
• Time with Mike Kurilla (questions and Mike’s response)

1. Does NCATS have plans to improve the single IRB and SMART Contracts process in a uniform way to accomplish the goal of reducing turnaround time to activate sites in multi-center studies?
a. NIH Clinical Center is now able to use SMART IRB
b. Version 3.0 will accommodate the Veterans Administration and the DOD
c. A more integrated system is the next step – uncertain about when this will be implemented.

2. Are there plans for an integrated, federated data warehouse that enables multi-center research across health systems that utilize different EMR platforms? Other countries with national EMR platforms can easily conduct large pragmatic effectiveness registry-based trials.
a. There are plans – not ready for public discussion
b. Future plans are for consortium wide system that will be informed by lessons learned from N3C to harmonize the diverse/disparate electronic health record data from across the country
c. NIH now feels that both the federated and tenant models have value and we need back-end systems that will allow for both approaches
d. Notion of a large scale synthetic dataset….could we create this to represent the entire country and make that available to the public. N3C has allowed us to validate some synthetic data. Advantage of synthetic dataset includes that there is no privacy risk.

3. The TL1 Directors are concerned that the new CSTA FOA will have the unintended consequence of reducing the number of CTSA trainees who are under-represented in science for a variety of reasons as already spelled out in the TL1 Executive Committee letter dated December 17,2021 (address to Drs Joni Rutter and Michael Kurilla). Would a drop of 20% or more in the number of graduate students and postdoctoral fellows who are underrepresented in science (by the NIH definition) cause NCATS to re-evaluate the decision to split the integrated TL1 funding mechanism into 3 separate T32s applications?
a. Development of the new FOA included a landscape analysis of the number of slots - NIh tried to keep the overall slot number the same.
b. Trying to get more consistency across the K and T programs. NIH wants to prevent one off small programs – tightening the overall program.
c. NIH believes that Reviews will be more rigorous with the FOAs separate.
d. Comment from our pod: Writing an institutional T for 2 slots is quite onerous. Poor return on investment for small hubs. Mike indicated that they will look at this after initial reviews (fall 2023) so that they can get feedback from reviewers.

4. How will the feedback from the early hubs who have experience with the new FOAs be considered by NCATS?
a. NCATS received written feedback – sharing with all – do not expect to provide any written response.
b. Waiting for first review – they want feedback from reviewers….do plan to meet with reviewers after first cycle and incorporate their feedback.
c. Carefully selected the UM1 funding code – has been a good code across NIH – and may offer timesavings for NIH during award time
d. NIH wants to see how well the K and Ts will be integrated and NIH recognizes that there may need to be adjustments after this.

Mike offered that ARPA-H is often a question he is asked – and he has no information yet on this to share.
NCATS will keep us informed as this develops.

Pod Meeting Summary Report

Summary Report: • Dr. Reilly shared updates with the Pod from the June and July Steering Committee meetings
• The Pod reviewed aspects of the clinical trials task force and upcoming JCTS thematic issues, as well as the DEIA task force report and survey. The Pod was supportive of submitting articles for the special JCTS theme issue. For the DEIA survey, the Pod recommends improvements to reduce the ambiguity of survey questions, if the survey is administered again in the future.
• The Pod was pleased to hear about Joni Rutter's proposal to have bidirectional discussions with Principal Investigators on clinical and translational science and the new "tea time" quarterly sessions. The PIs are encouraged by this but expressed some wariness and a strong request and hope that it is framed in a manner that leads to more collaborative opportunities for priorities discussed and agreed upon between the PIs and NCATS for the CTSA Program and beyond.
• This stimulated further discussion within the Pod on the best mechanisms for collaborations between NCATS and the PIs, their CTSA hubs and institutions, and how best to enhance communication within the network also. Its expected that these ongoing discussions will continue to produce ideas that will be shared

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Summary Report

Summary Report: POD discussion of July CTSA Steering Committee meeting
 Impactful Clinical Trials
• The Pod discussed “word choice” – “impactful” vs “informative”
 seems an evolutionary change in word choice in which terms may be related but not completely synonymous
 impactful can imply more population effect (efficacy + reach)
 clarity of intent would be helpful
• JCTS Call for Manuscripts for Themed Issue on Innovations for Enhancing the Informativeness and Quality of Clinical Trials
 Potential Topics:
• Strategies to enhance the quality of clinical trials
• Strategies to optimize diversity in clinical trial design
• Contributions of implementation science toward optimizing clinical trial design
• Lessons learned from adaptive and real-world clinical trial designs during COVID-19
• Enhancing clinical trial design through cohort exploration in electronic health care systems
• Benefits of clinical trial management systems
• Educational approaches for clinical trial design
• Optimizing clinical trials for the digital age
• Institutional responsibilities and best practices for conducting clinical trials
 Manuscripts may be submitted for peer review in any of the Journal’s article types
• Types: https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science/information/instructions-contributors#journalstyle
 Enhancing Communication between CTSA Hubs and NCATS
• Joni Rutter has expressed her eagerness to find effective ways to ensure bidirectional communication between NCATS and CTSA Hubs and to develop new approaches and/or refine existing modes
 Strive for more real give and take
 Seek a format that balances size of group and feasibility
 Leverage the tremendous and deep expertise among CTSA PD/PIs and Senior Administrators as thought leaders and as a brain trust in clinical & translational science
• Our CTSA Pod is interested in understanding:
 What does Dr. Rutter want to know? What key issues is Dr. Rutter managing or deliberating?
• What does she want now which Hubs might help with?
 Is there an opportunity to better understand the process of providing feedback? What happens with suggestions offerred? What steps can be taken to demonstrate CTSAs have been heard?
 Collaboration & Engagement EC Update
• Consideration of the recent National Academy of Science Perspectives paper, entitled “Assessing Meaningful Community Engagement: A Conceptual Model to Advance Health Equity through Transformed Systems for Health”
• ACTS is also considering a new special interest group on justice, equity, diversity and inclusion (JEDI) to address research design/conduct and workforce development (building on BERD JEDI working group)

ACTION:
• See the JCTS Themed Issue Invitation Here (and attached): https://www.cambridge.org/core/services/aop-file-manager/file/62d80d3db904740dc062ff38/1072-JCTS-qualityoftrials.pdf
o Submissions due no later than January 31, 2023.
• Our Pod appreciated Mike Kurilla’s participation in our June meeting and hopes that there will be additional opportunities for Pod discussions with Rutter and Kurilla together.
• Please find the NAM article, attached
Other Topics
 Trial Innovation Network
• Program will be sustained, but some of the leading R2D2 sites may change effective 7/1/23 (proposals under review now).
• Data on the progress of the TIN, TIC & RIC are being compiled now (due in September and November)
• Documentation and instructions on how to navigate tools and sites during this transition phase will be forthcoming
 NCATS Reorganization
• In June, NCATS presented to the Steering Committee a new org chart reflecting changes in division structure, creation of new roles
ACTION:
• Regarding NCATS reorg, our Pod would like to resubmit our previously requested clarification by NCATS of the i) charge of each major subunit, ii) responsibilities of team members (so we know who to contact for what), and iii) recruitment plans for vacancies
Reminders
 CTSA FOA Technical Webinar (Oct 12, 1pm ET): https://grants.nih.gov/grants/guide/notice-files/NOT-TR-22-034.html
 CTSA Steering Committee DEIA Task Force: Phase I Survey Deadline August 31, 2022
• Word document link: https://rochester.app.box.com/s/vo84nqrcswv2f96famg7h6tsz5apghtl
• Survey Link sent to your attention on Friday July 8 from surveys@clic-ctsa.org
 CTSA Steering Committee is receptive to Working Group Proposals, Submit Here: https://clic-ctsa.org/groups/working-groups-proposal-information
 New link for CTSA Program Webinars: Register Here: CTSA Program Webinars – July 2022 – June 2023 Series
 November CTSA PI Meeting, Registration Open: https://clic-ctsa.org/form/2022-fall-ctsa-program-meeting-r

Pod Meeting Summary Report

Summary Report: Pod Lead: Ruth O'Hara, Stanford
Pod Membership: Stanford, Medical College of Wisconsin, UCI, UCLA, UCSD, USC,
Meeting Dates: June 27th, July 25th and August 22nd.

Issues of Concern to the Pod:
1. Members of our Pod expressed concern about the distinctions in the FOA among translational research, translational science, and the Science of Translation. Pod members expressed concern that these definitions risk placing false distinctions among these components of the translational research chain.
2. Pod members were concerned about the implications of these distinctions for the CTSA review process under the new FOA.
3. Pod members also had concerns regarding how the distinction between clinical trials and human studies that are not clinical trials will be made for RC2 applications. The FOA specifies that RC2s proposing a NIH defined clinical trial will be considered nonresponsive and not reviewed.

Solutions and Additional Information Requested:
1. Regarding the implications of distinctions among TR, TS, and SoT, for the review process, we invited Mike Kurilla to join our Pod for an excellent discussion of this issue. Mike Kurilla followed up with his September Blog on "Divining the Venn Diagram of Translational Research versus Translational Science." This provided considerable assurance, but some felt more needed to be done.
2. Pod members aim to draft a manuscript tackling the nosology of TR, TS, and SoT, that reflects the evolution and maturing of this field. Investigators at our Hubs will be invited to contribute, and we are delighted to extend this invite more broadly.
3. With respect to clinical trial determination, as with Human Subjects research, the Clinical Trial determination is entered by the applicant. NIH provides tools for applicants to assist in making the determination whether or not a study meets the NIH definition of a clinical trial. Reviewers confirm whether that determination is correct or not, and are provided with these definitions in the review pre-review orientation. Applicants are also encouraged to consult with Program Officials at NCATS on whether their study meets the definition of a clinical trial or not before submission.

Pod Meeting Summary Report

Summary Report: Discussion:
1. Follow up on Mike Kurilla visit in July. Pod members appreciated time with Dr. Kurilla.
2. DEIA survey discussion - Pod members are working on surveys. Expressed concerns about survey design, privacy issues, federal and local regulations regarding asking for the information from hub team members, and discrepancies in data collection methods (HR feed versus confidential surveys distributed by hub). The group expects there may be a substantial non-response or "prefer not to answer" rate due to these issues.
3. Discussion of the compiled CTSA FOA comments. Pod members appreciate the efforts of the teams who contributed to the document to offer their perspectives. These comments were viewed as helpful and were validated by pod members own experience. The pod would like to hear NCATS response to the comments. The pod specifically asked about whether there are plans to combine the T32s into a single application.

Pod Meeting Summary Report

Summary Report: POD report. August 23
1) We did not meet in July so provided summary of the last three CTSA SC meetings
2) Presented tea-time with Joni- Feedback as follows:
Great NCATS is thinking of doing this but some concerns about including institutional leader
• Institutional leaders may not have time to be at 90-minute meeting
• If want engage these leaders should be something succinct and well-focused
• It may back-fire to ask leaders to be at 90-minute meeting esp with 122 people, they may not be engaged well at such a venue
• CTSI PIs are often the institutional leaders on CTS/CTR and the ones whom often know most about it. Usually the senior institutional leader defer to CTSA PI on all things CTS/CTR related
• Consider smaller sessions say tea-time with Joni at POD groups
Other Items:
3) We discussed agenda for next month’s meeting with M. Kurilla- topics include discussion around FOA and review process, limited number UL1 diversity supplements,
4) Reminded group about DEIA survey – some discussion of challenges I presented my perspective as part of DEIA EC
5) Questions raised around ACT network and CD2H. How will they intersect? concerns about funding- “we all want help and be good stewards but to what extent will this be an unfunded mandate”

Pod Meeting Summary Report

Summary Report:  The Pod discussed the materials and discussion from the recent Steering Committee meetings and plans/content for Fall CTSA meeting in DC.
 The Pod discussed the shared experience of some hubs who have applied to the CTSA Program under the new FOA, including a discussion on Element E clinical/translational projects and shared ideas.
 The Pod continues to discuss ways to increase cross consortium PI/institution interactions and collaborations and in particular how ACTS can be a convener and forum for bringing together the national clinical and translational research leaders and community around ideas for harmonized work at large scale, and there are opportunities to further leverage those connections.

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Summary Report

Summary Report: Discussed the following items:
• Steering Committee is looking for new members (Self-nomination (not been on since 2016 and have 2-3 years on the grant))
• OIG report with critical information regarding ClinicalTrials.gov
• New Data Management Sharing Policy (NOT-TR-22-034)
• Further discussion on TL1s and cost vs. benefit (possible merging of T pre- and post-doc components)
• 1ST round of new CTSA FOA submissions

Pod Meeting Summary Report

Summary Report: Pod meeting summary:
1) CTSA review cycle and FOA discussion
-Concern over broad range, high (poor) scores, and non-discussed T, K, RC's and other grants. Concern over continued confusion of new FOA and disintegration of K, T and other components, as well as reviewer pool and process of the grants.
2) Uncertainty on unfunded mandates e.g., N3C and ENACT.
-Pod felt it is important for the SC to review the funding mechanisms of the hubs as well as the productivity and impact of N3C et al. [to be submitted as “Idea sharing” feedback for NCATS]
3) Discussion of the transition in coordinating centers.
-Contract received by an organization, the Pod would like to hear more on the remit, function, activities, and governance. [to be submitted as “request for response” from NCATS]

Pod Meeting Summary Report

Summary Report: 1. Review of Sept/Oct SC meeting content. Jason Umans spoke about the Visiting Scholar program briefly.
2. Discussion of ClinicalTrials.Gov and pod institutional support for resources to support investigator compliance. Best practices were shared.
3. Plan for in-person gathering of the East Coast Pod at the annual meeting
4. Cancellation of Nov and Dec meetings.

Pod Meeting Summary Report

Summary Report: 1) we met on nov 7-this was before the joni rutter announcement. The group felt that it would be helpful to have an external review of the CTSA program. The National Academy was one suggested. It was also suggested that PIs reps be included. It was also suggested that in prep for this event, the PI be asked to provide their 3 major goals for their HUB.
2) another topic discussed was the perception that the CTSA programs needs to market the programs high level achievements. some suggestions # of K scholar who have gone on to be funded, high impact clinical trials performed by CTSA consortium (w TIN, ACTS or simply many hubs as sites).
3) another issue discussed was the need to have a generalized CTSA wide dissemination approach.
4) concern was raised with the specifics of the transition from CLIC to new private business handling CLIC roles. Also some concern raised re: idea that there will be another attempt to develop metrics (now called impact). During steering committee meeting, it did not seem that the new consultant group had a feel for how and where to start.

Pod Meeting Summary Report

Summary Report: NCATS Organization
 Joni Rutter announced as formal Director of NCATS
 Proposed organizational changes (May 2022) and Org Chart (May 2022)
Health Informatics Platforms to turn Real-World Data into Real-World Evidence
 National COVID Cohort Collaborative (N3C)
o Centralized data enclave model
o 2021 Funding (from chat): NIH to Award IDIQ for NCATS Secure Scientific Platforms Environment Support for the NCATS N3C Data Enclave (COVID-19) https://www.fedhealthit.com/2021/08/nih-to-award-idiq-for-ncats-secure-scientific-platforms-environment-support-for-the-ncats-n3c-data-enclave-covid-19/
o Anticipating pilot projects by JHU & UColorado, details to be determined
o The Pod expressed concerns about
 The substantial funding needed and the risk to the CTSA Hub allocation
 The lack of a clear sustainability plan
 The challenge of institutions moving from pandemic-incentivized COVID-only to full EHR data
 The burden on Hubs to participate without funded role
 The diversion of resources away from actual research to building infrastructure

 ENACT: Translating Health Informatics Tools to Research and Clinical Decision Making
o NCATS support to become the largest federated network for EHR-based research (>140M de-identified patients) that can be accessed on desktops only by investigators at participating sites.
o Funding Mechanism: Limited Competition: CTSA Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (1U24TR004111; 5 year award)
o ACTION: Save the Dates for
 Informational Webinar:
We are writing to invite CTSA PIs and their lead administrators to attend an informational webinar on the ENACT network on December 6, 2022 from 12-1 PM ET, which can be accessed at: https://chartis.zoom.us/j/2369859742?from=addon, password 135. The webinar will present:
- ENACT Overview- scope, how it works, uses
- Plans for new functionality- data quality, interoperability, expanded ontology and, ultimately, use for clinical decision-making
- Site involvement- an invitation to inform development priorities, clarity on maintaining capacity

We plan for this webinar to be interactive, with a 15 minute presentation followed by an opportunity for discussion/Q&A.

 Technical Webinar:
There will be a second in-depth technical webinar for your informatics colleagues that is tentatively scheduled for December 13, 2022 from 12-1 PM ET. Invitations will be sent out in the near future.
NCATS Operational Contract - Coordination, Communication, and Operations Support (CCOS) Center
 Digital Infuzion https://www.digitalinfuzion.com/
 CLIC to be sunsetted by June 2023

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Summary Report

Summary Report: Meeting summary:
Discussed updates on ENACT, CCOS transition, new Working Groups approved, and Roundtable summary
The pod discussed having the CCOS team attend pod meeting to discuss the transition. Will invite.

Pod Meeting Summary Report

Summary Report: The Pod discussed several updates including N3C, Dr. Rutter's recent CTSA roundtable discussions, review of recent Steering Committee meetings and new members, the launch of CCOS, the Spring 2023 ACTS conference and CTSA meeting, Fall 2023 CTSA meeting planning, and stipends for TL1 trainees.

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Summary Report

Summary Report: This was our first pod meeting and topics were as follows:

1. Introductions

2. Goals of pods

3. Discussion of desired frequency of meetings (monthly)

4. Discussion of desired topics
• Discussion of new FOA and what we might expect down the road in terms of funding mechanisms
• Convening in person at TS23
• Discussion of challenges we may be facing – e.g. shift in way that partner institutions are structured in the new FOA
• Sharing information, e.g., how other hubs are structured, process by which decisions are made, strategic planning, building trust, etc.
• Each pod could provide a 10-minute overview of our CTSAs or specific topics.
• Developing the next generation of people interested in being a mid- or senior-level leader in the CTSA – succession planning.
• Developing pipeline of MD researchers
• Share Steering Committee powerpoints and touch on high points”
• When topic emerges from SC, pod members might bring in leaders in from other areas of the CTSA to discuss these topics.
• Split time at each meeting between overview of high points from SC meetings, some structured topics, and some time for unstructured discussion and SC feedback.

5. Review of powerpoints from SC meetings

January 9
• New steering committee introductions
• Responsibilities and Pod feedback process
• CTSA roundtable feedback
• FY23 omnibus – Consolidated Appropriations Act 2023

January 23
• Notification of release of information on CTSA program websites
• Pod feedback
• Fall meeting survey results
• CCOS (Coordination, Communication, and Operations Support) transition (from CLIC) timeline
• Spring meeting updates

February 13
• Advancing Dissemination and Implementation Sciences WG
• Crowd sourced agenda topics
• Fall meeting pod exercise results (suggestions for fall meeting)
• Spring meeting updates
• Fall meeting updates
• What are the programs sunsetting because of areas not funded in the new FOA?
• Discussion of in-person vs. remote work and downsides of remote work.

6. Open discussion and questions/feedback for SC
There is a disparity between growing need for infrastructure but less funding for this (Element E means that there is less funding for them) - there is only so much the sites can do to stretch the funds. Maintaining the quality of the service has become difficult as the better the service is, the more people show up for that service.

Pod Meeting Summary Report

Summary Report: 1. Discussed "crowd source" topic requests to be shared with the Steering Committee. Pod members to bring ideas to our next meeting.
2. Discussed update on spring ACTS meeting including the UL1 in-person PI networking meeting.
3. Early planning for fall 2023 CTSA meeting - shared potential dates as presented to SC.
4. CCOS leadership (Kerry James and Stephan Bour) attended meeting for brief update about the CCOS transition. Discussed website transition. Pod members expressed desire to see website mock-ups and Stephan offered to send working version after NCATS meeting this week. CCOS explained that there will be public website and private portal for CTSA hubs. Login information still in development - this is area of concern for the pod members.

Pod Meeting Summary Report

Summary Report: After discussing the Steering Committee meetings, only a few issues were brought up by the hubs:
1. The 2024 ACTS meeting will be in Las Vegas. Does NCATS plan to hold the 2024 Spring meeting there as well?
2. Some further discussion of how NCATS views the RC2 grants would be appreciated. They were originally described as a replacement for the hubs' UL1 Special Projects, but many fewer were funded than UM1's. Has NCATS leadership changed its view of their place in the consortium?
3. Some ideas were advanced for Fall Meeting sessions:
• Translational Science vs. Translational Research
• CTSA Funded Projects/RFA Listening Sessions
• D&I
• Best Practices
• Impact

Pod Meeting Summary Report

Summary Report File:

Pod Meeting Summary Report

Summary Report: Minutes
Review of powerpoints from steering committee meetings 2/27 and 3/13
• Meeting 2/27
o Crowd-sourced agenda topics
 Exploring ways to enhance communication between NCATS, SC, and the hubs
 Steering committee meets every two weeks and prior to that, there is a co-chair meeting with Mike Kurilla to go over the agenda
 They would like feedback on particular topics that the SC should include in the agendas
 There is also a way to submit input about agenda items on the CLIC (soon to be the CCOS) website
 If there are similar or overlapping concepts proposed, those would be prioritized and may make it onto the fall or spring meetings
 It would be helpful to look at what has been proposed so far (action: Duane will send out) –clarify how many data sharing platforms will be rolled out and how these will be supported centrally, are there singular issues that the SC and the network might want to tackle at the CTSA meeting (OIG report on best practices for clinical trials and data sharing)
 Action for all Pod members: send suggestions to Jessica by email and she will submit them
 Discussion of efforts to increase bidirectional communication between Pods and NCATS

• Meeting 3/13
o One of the challenges will be to define the diagnoses when we broaden beyond COVID-19? Depends on whether the diseases are part of the CDM with clear definitions or whether they have to create a common data definition. Dx codes often need additional validation with other EHR sources. Great for high-level diagnoses or rare diseases but not as good for diseases with complex etiologies. Diagnosis codes over time are also challenging.
o How is NCATS thinking of synergies with existing large databases (e.g. with respect to Alzheimer’s) or with All of Us? Seem to be parallel activities.
o N3C was catalyzed by the urgency of COVID.
o How usable will the N3C model be? It created a complex enclave that only data scientists could navigate – don’t have broad impact for our trainees and active projects in our hubs. How could this be made more democratized and usable for the hubs that are putting significant resources into it? Is it as scalable as they hope? It is not a trivial investment by the CTSA hubs. You have to know how to use their platform – there is no downloading. All analysis happens on their platform. We will need more tools to make the resource more usable.
o Learning from other sites around best practices would be more useful than discussing the OIG report around compliance – maybe it’s more about how to support the research community – broader topic around clinical trials and best practices (reporting and compliance as a sub-bullet)

Open discussion, feedback for SC, and agenda items for next meeting
• Next meeting scheduled for April 26 – group would like to meet in person to get to know each other at the CTSA meeting the week before, and to use the April 26 meeting to debrief about the CTSA meeting
• May meeting – Duane will present a 10-minute overview of his site – focus on innovations, a specific project that might be collaborative, challenges, a project in need of input, etc.

Pod Meeting Summary Report

Summary Report: Reviewed potential crowd source topics for Steering Committee. Pod members would like to review whether there are changes in the post doctoral T32 slots for newly funded hubs.
Discussed Steering Committee topic of data platforms - and pod is enthusiastic about having N3C and ENACT leaders visit with the pod.
Discussed need for submission of new Working Group applications by March 31. Leaders from T training programs plan to submit a proposal.

Pod Meeting Summary Report

Summary Report: Our POD had an excellent discussion about N3C and Enact.
University of Kentucky
University of Alabama - Birmingham
Boston University
UT Southwestern
UT Health Science Center