CTSA PI and SC Call - May 28, 2014

For June 4th CTSI Executive Committee Meeting

Transcript

1. The National Center for Advancing Translational Sciences CTSA PI and Steering Committee Update MAY 28, 2014 2-3 PM EST
2. Agenda 2 1. Introduction (Nora Disis) 2. NCATS Update (Petra Kaufmann) - 5 minutes 3. CTSA PI-SC Retreat Planning Committee Bruce Blazar, Bob Kimberly Co-Chairs (5 minutes presentation plus 10 minutes discussion) 4. Network Projects Pipeline (Nora Disis)  IRB Reliance (3 minutes) John Clore, Alan Green Question IRB Reliance (5 minutes)  Accrual to Clinical Trials (ACT) (3 minutes) Bob Toto, Steve Reis, Lee Nadler Question Accrual to Clinical Trials (5 minutes)  Site Personnel Qualification (3 minutes) Rick Barohn, Tom Shanley Questions Site Personnel Qualification (5 minutes) 5. General Questions and Discussion
3. Clinical and Translational Science Awards NCATS Division of Clinical Innovation • Support a national consortium of outstanding medical research institutions that have created academic homes for translational research • Build on the existing local strength at the CTSAs and work together as a network to improve the way clinical and translational research is conducted nationwide  Clinical trials, including some funded by the NIH, increasingly move outside the US.  Addressing this crisis nationally will increase local research opportunities. • Accelerate the path from discovery to health • Provide innovative training for clinical and translational researchers 3
4. Evolution of the CTSA Program • June 2013 IOM report finds CTSA program  a worthwhile investment that has resulted in the successful establishment of academic focal points for translational and clinical research  a program that would benefit from a variety of revisions • May 2014 NCATS Advisory Council Working Group  Develop meaningful, measurable goals and outcomes for the CTSA program that address the recommendations of the IOM report, and;  Speak to critical issues and opportunities across the full spectrum of clinical and translational sciences. 4 http://www.ncats.nih.gov/about/ncats-council/wgs/ctsa-iom/ctsa-iom.html
5. Development of Strategic Goals WG Focus Areas  Strategic Goal Recommendations • Training and education • Collaboration and partnerships • Community engagement of all stakeholders • Academic environment for translational science • Translational science across the lifespan and unique populations • Formalize and standardize evaluation processes • Advance innovation in education and training programs • Ensure community engagement in all phases of research • Strengthen clinical and translational science relevant to child health IOM Report Recommendations WG Focus Areas Strategic Goal Recommendations • Workforce Development • Collaboration and Engagement • Integration • Methods, and Processes 5
6. Strategic Goal: Workforce Development The translational science workforce has the skills and knowledge necessary to advance translation of discoveries • For research staff at all levels, provide training that is harmonized across studies and CTSA sites (GCP). • For K scholars, provide innovative curricula that include a focus on non-traditional study areas such as regulatory science or entrepreneurship, and that offer “mini sabbaticals” in academia or industry to enrich the training experience. • In graduate training programs, focus on methodological rigor and transparency in reporting to enhance the validity and reproducibility of pre-clinical research. • Create an environment where team science and translational science is a viable career path, for example by adjusting promotion criteria to meet the needs of today. 6
7. Strategic Goal: Collaboration/Engagement Engaging stakeholder communities across the translational spectrum  Include patients  early on in the concept development to make sure we answer questions that matter to patients  in protocol development to make sure that the plan is feasible in terms of participant burden  in considering risk/benefit relationships and in developing consent language  in considering endpoints to make sure that what is measures matters to them  in developing communication plans to make sure messages reach relevant communities  Include all relevant stakeholders in the health care delivery system (e.g. hospitals, office-based clinicians)  Promote partnerships with industry and non-profit organizations  Identify and disseminate successful collaboration models 7
8. Strategic Goal: Integration • Consider the entire lifespan in translational research  Pediatric populations  Elderly populations • Promote the study of population difference in disease progression and treatment response • Support implementation science  Across the lifespan  Across all populations, especially those experiencing health disparities 8
9. Strategic Goal: Processes/Methods • Use innovations in data and privacy technology to accelerate translation of science  Research-friendly consent forms  Data standards  Cohort identification • Identify key roadblocks to minimize inefficiencies  Building network capacity  Streamlining IRB, contracting, training and site qualification • Adherence to high quality methods and processes 9
10. Conclusions • The CTSA program has created academic homes for translational and clinical research and training • Adding network capacity to this local strength maximizes the value of the CTSAs for translational research nationwide • Our shared goal is to bring discoveries to patients and communities faster • Building on the existing strength at the CTSAs, NCATS will implement the recommended changes  with advice from the Council Working Group  and with input from CTSA investigators 10
11. CTSA PI MEETING BRUCE BLAZAR, ROBERT KIMBERLY Planning Committee: Bruce Blazar, co-chair Bob Kimberly, co-chair Lee Nadler Kathleen Brady Nora Disis Gordon Bernard Petra Kaufmann 11
12. CTSA PI Meeting July 8, 2014, Bethesda MD (Hyatt) 7:30 AM Coffee 8-10:00 AM Session 1: NCATS and CTSA dialogue: Structure and process 8-8:40 AM Austin, 8:40-9.10AM Kaufmann, 9:10-10:10 Q&A (Moderator: Disis) 10:10-10:30 AM Break 10:30-12 noon Session 2: Building network capacity – current projects IRB Agreements, Participant Accrual, Master Contracts, Site Qualification (Moderators: Disis and Kaufmann) 12-12:30 PM Lunch 12:30-3:00 PM Session 3: New Ideas for CTSA Network 12:30-12:45PM Overview (Blazar and Kimberly) 12:45-3:00 PM Presentation of Ideas for Network (5 ideas, 10 minutes each plus 5 minutes Q&A, moderated by Blazar and Kimberly) 3:00-3:30 PM Wrap up Q&A with Steering Committee, Adjourn 3:00 PM 12
13. Process • Submit Network Ideas  Simple form for 250 word abstracts  Page 1 with investigator information (lead and team)  Page 2 without names, just description of the project • Criteria  Strengthens CTSA capacity as a network  Improves quality and/or accelerates progress in the national translational research enterprise  Implements IOM recommendations  Builds on existing effort at ≥ 1 of the CTSAs  Success can be defined and measured 13
14. Timelines May 28, 2014 PI and Steering Committee Call Bruce Blazar to introduce plans to PI’s and receive feedback Early June Solicit abstracts with CTSA network ideas Mid June Abstracts (de-identified) are shared with CTSA investigators for ranking preferences June 20, 2014 • Steering Committee and Meeting Planning Committee select 3-5 projects for presentation based on ranking • Presenters are notified July 8, 2014 Presentations at PI Meeting in Bethesda 14
15. TOWARD A NATIONAL IRB SYSTEM ALAN GREEN AND JOHN CLORE 15
16. May 21, 2014, face-to-face meeting in Chicago 16 • PARTICIPANTS: CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE-CTSC: Philip Cola DARTMOUTH SYNERGY: Alan Green, MD, Sheila Noone, PhD HARVARD CATALYST: Lee Nadler, MD, Barbara Bierer, MD, Sabune Winkler, JD, Doug MacFadden, MF NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS): Elaine Collier, MD, Petra Kaufmann, MD, MSc UNIVERSITY OF CALIFORNIA BIOMEDICAL RESEARCH ACCELERATION, INTEGRATION & DEVELOPMENT: Eric Mah, Rachael Sak, RN,MPH, Kent Anderson, MS UC DAVIS: Deborah Diercks, MD,MSc The UNIVERSITY OF NEW MEXICO: Michael Briggs, Corey Ford, MD, PhD, Emily Ringo UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH: Nicelle Cobb, PhD, Marc Drezner,MD, Carol Pech, PhD UT SOUTHWESTERN: Lindsey Cowell, Ph.D., Diane Sheppard, RN, Angela Wishon, JD VANDERBILT UNIVERSITY: Gordon Bernard, MD, Terri Edwards, Emily Sheffer, MPA VIRGINIA COMMONWEALTH UNIVERSITY: John Clore, MD, MS • Discussed pros/cons of existing models: Commercial IRB; IRB Share; Central IRB; IRB Reliance • Developed consensus to use IRB Reliance as overarching national model • Discussed regional vs. national strategy • Submit administrative supplement to NCATS for support of Year 1 activities (June, 2014) • Executive Committee: PIs of primary regional sites  Harmonization Subcommittee – create national IRB reliance agreement model  Informatics Resource Subcommittee – propose informatics structure to support national IRB reliance model  Implementation Subcommittee – develop/monitor roll-out plan • Preliminary Implementation Strategy:  Build intra-regional agreements toward a national IRB network utilizing national IRB reliance language  Any expansion of regional consortia utilizing national IRB agreement language  Launch a multi-site (> 10 sites) clinical study by end of Year 1  Design sustainability model going forward
17. ACCRUAL TO CLINICAL TRIALS (ACT) STEVEN REIS, ROBERT TOTO, LEE NADLER, GARY FIRESTEIN 17
18. CTSA Accrual to Clinical Trials (ACT) • Face-to-face meeting in Chicago on April 21, 2014 • Goal is to create a federated network of sites to improve participant accrual into clinical trials • Stage I: Create capacity at multiple sites to explore cohorts leveraging electronic health records (EHR) • Stage II: create approaches to contacting patients eligible for trial enrollment • Stage III: Tools for patients and providers to identify trials 18
19. SITE AND PERSONNEL QUALIFICATION RICHARD BAROHN AND THOMAS SHANLEY 19
20. Site and Personnel Qualification • Accelerate site initiation by harmonizing procedures across sites. • Provide web-based, user-friendly systems for sponsors to gather basic facts on site qualification. • Harmonize research personnel training and qualification across CTSA sites, starting with GCP. • Harmonize basic start-up and site SOPs. • Standardize CTSA scientific reviews of projects to enhance quality. 20
21. Q & A OPEN DISCUSSION 21