TRCC Patient and Investigator Pools Workgroup November Status Report

1. TRCC Patient and Investigator Pools Workgroup November Status Report

2. Investigator and Patient Pools Workgroup John Roache Joe McCormick Deborah Mote Kim Medellin Dan Karp Mike Fallon Kathy Franco Mary Weyant Blair Holbein Adrianne Rhea Don Powell Bill Calhoun Kristin Parks

3. Key Initiative #1: Create master list of clinical trial investigators/ research specialties Intent (why): Promote trials & network investigators • Knowledge of local Investigator and Patient Resources is Important • Established research groups have group databases and CRU’s generally can list their investigators, but no CTSA has ready access to institutional lists, or databases. • Most CTSA’s believe they could create a list or obtain the information through a laborious manual process, but no such list exists now; • A ready and accessible database would be helpful • …but, • Velos may (or may not) be the solution, some years down the road; • Not clear that IT resources are available or that effort/expense justifies the need.

4. Key Initiative #1: Create master list of clinical trial investigators/ research specialties Intent (why): Promote trials & network investigators • Knowledge of local Investigator and Patient Resources is Important • Established research groups have group databases and CRU’s generally can list their investigators, but no CTSA has ready access to institutional lists, or databases. • Most CTSA’s believe they could create a list or obtain the information through a laborious manual process, but no such list exists now; • A ready and accessible database would be helpful • …but, • Velos may (or may not) be the solution, some years down the road; • Not clear that IT resources are available or that effort/expense justifies the need. ACTION ITEM(S): • The Group will assure that single “Points of Contact” are available and identifiable so that collaborative Network Trials are facilitated. • Work towards growing and maintaining lists of trials Investigators and Patient Pools and implement VELOS in ways to support this automatically.

5. Key Initiative #2: Identify & support a multi-site NIH/ Federal trial within the TRCC Network Intent (why): Support a network trial Study 1: Neurological Emergencies Treatment Trials (NETT) Sponsor: NIH/NETT PI: Elizabeth Jones (UT-H) Co.I. (Sites): Mileski/Powell (UTMB) Study 2: Genetic Risks for Bicuspid Aortic Valve Disease Sponsor: IIMS-KL2 PI: Siddharth Prakash (UT-H) Co.I. (Sites): Bethea (UTSW), Fujise (UTMB) Study 3: Non-Alcoholic Steatohepititis (NASH) Trial Sponsor: UTMB funds PI: Abate (UTMB) Co.I. (Sites): Fallon (UT-H), others?

6. Key Initiative #2: Identify & support a multi-site NIH/ Federal trial within the TRCC Network Intent (why): Support a network trial Study 1: Neurological Emergencies Treatment Trials (NETT) Sponsor: NIH/NETT PI: Elizabeth Jones (UT-H) Co.I. (Sites): Mileski/Powell (UTMB) Study 2: Genetic Risks for Bicuspid Aortic Valve Disease Sponsor: IIMS-KL2 PI: Siddharth Prakash (UT-H) Co.I. (Sites): Bethea (UTSW), Fujise (UTMB) Study 3: Non-Alcoholic Steatohepititis (NASH) Trial Sponsor: UTMB funds PI: Abate (UTMB) Co.I. (Sites): Fallon (UT-H), others?

7. Key Initiative #3: Define standardized trial metrics Intent (why): Track performance in a standardized way across TRCC NIH Sponsored Trial Metrics • # of grants 1st submitted • % funded on 1st submission • # of grants resubmitted (2nd submission) • % funded on 2nd submission • % requiring 2nd submission • # Days from JIT to NOGA • # Days from initial IRB submission for review to IRB Final Approval • # Days from IRB Final Approval to first patient visit • # Days from IRB Approval to any other final institutional approvals • # Days from 1st patient visit to last patient visit • % patient enrollment/accrual goal • # Publications • % First/Last Authored

8. INDUSTRY METRICS • # CDA's submitted • # CDA's approved • # CTA / Contracts Submitted • # CTA / Contracts Approved • % Contracts finally Approved • # Days for CDA approval from Sponsor to OSP • # Days from initial OSP submission to Final CTA Approval • # Days from initial IRB submission for review to IRB Final Approval • # Days from IRB Final Approval to Final Sponsor Approval to enroll pts • # Days from Sponsor Approval to 1st patient visit • # Days from IRB Approval to any other final institutional approvals • # Days from 1st patient visit to last patient visit • % patient enrollment/accrual goal • # Publications • % First/Last Authored

9. INDUSTRY METRICS • # CDA's submitted • # CDA's approved • # CTA / Contracts Submitted • # CTA / Contracts Approved • % Contracts finally Approved • # Days for CDA approval from Sponsor to OSP • # Days from initial OSP submission to Final CTA Approval • # Days from initial IRB submission for review to IRB Final Approval • # Days from IRB Final Approval to Final Sponsor Approval to enroll pts • # Days from Sponsor Approval to 1st patient visit • # Days from IRB Approval to any other final institutional approvals • # Days from 1st patient visit to last patient visit • % patient enrollment/accrual goal • # Publications • % First/Last Authored

10. Key Initiative #4: Produce list of industry master agreements for each institution Intent (why): Increase awareness of industry master agreements • Need to inform Investigators in order to take advantage • Committee #5 (Regulatory) working on issues of Master Trials Agreements (MTAs) • Offices of Sponsored Programs (OSP) at each UT-site applies MTAs • …but • Investigators unaware of MTA engage in negotiations; • Many CRO’s reject MTA’s and individually negotiate; • …and OSP’s accept. • There appear to be UT-System MTAs but also are local UT Institutional Agreements as well (i.e., the big “M” vs. the little “m”) ACTION ITEM(S): • Generate The List! …for Investigators at each CTSA Site • Gain help from UT System to “enforce” MTA’s and Sponsor/CRO compliance.

11. Key Initiative #4: Produce list of industry master agreements for each institution Intent (why): Increase awareness of industry master agreements • Need to inform Investigators in order to take advantage • Committee #5 (Regulatory) working on issues of Master Trials Agreements (MTAs) • Offices of Sponsored Programs (OSP) at each UT-site applies MTAs • …but • Investigators unaware of MTA engage in negotiations; • Many CRO’s reject MTA’s and individually negotiate; • …and OSP’s accept. • There appear to be UT-System MTAs but also are local UT Institutional Agreements as well (i.e., the big “M” vs. the little “m”) NOTE: Light at the End of the AE Tunnel ! ACTION ITEM(S): • Generate The List! …for Investigators at each CTSA Site • Gain help from UT System to “enforce” MTA’s and Sponsor/CRO compliance.

12. Key Initiative #5: Implement I2B2 use at each institution to access patient pools (for preparatory to research and recruitment) Intent (why): Enable each institution to address prep research/ study feasibility Report Summary Environment • Installed - All sites • Budgeted- 3 of 4 sites • In test- All sites • Production- 3 of 4 sites Data Source Tables • Epic- 3 of 4 sites • Axium- 2 of 4 sites Other • User Access - 3 of 4 sites • IRB Approved- 1 of 4 sites • Budget Estimate • $300k-500k or less if UTH central site and level of site skill sets • UT-Houston uses I2B2 for: • Preparatory for Research Feasibility • Patient Recruitment

13. Key Initiative #5: Implement I2B2 use at each institution to access patient pools (for preparatory to research and recruitment) Intent (why): Enable each institution to address prep research/ study feasibility Report Summary Environment • Installed - All sites • Budgeted- 3 of 4 sites • In test- All sites • Production- 3 of 4 sites Data Source Tables • Epic- 3 of 4 sites • Axium- 2 of 4 sites Other • User Access - 3 of 4 sites • IRB Approved- 1 of 4 sites • Budget Estimate • $300k-500k or less if UTH central site and level of site skill sets ACTION ITEM(S): • Each site acknowledges need for a means to search EMR for “preparatory” feasibility and for “patient recruitment”. • UT-Houston offers support for implementation of I2B2: • Sharing Best Practices; and/or • Providing Expertise and Support for using I2B2 at each site; or • Hosting an I2B2 application accessing site EMR’s • Other sites may want to use other approaches to the same problem • Will explore the use of Health Information Exchanges and/or local site Informatics approaches.

14. Key Initiative#5: Implement I2B2 use at each institution to access patient pools (for preparatory to research and recruitment) Intent (why): Enable each institution to address prep research/ study feasibility Report Summary Environment • Installed - All sites • Budgeted- 3 of 4 sites • In test- All sites • Production- 3 of 4 sites Data Source Tables • Epic- 3 of 4 sites • Axium- 2 of 4 sites Other • User Access - 3 of 4 sites • IRB Approved- 1 of 4 sites • Budget Estimate • $300k-500k or less if UTH central site and level of site skill sets ACTION ITEM(S): • Each site acknowledges need for a means to search EMR for “preparatory” feasibility and for “patient recruitment”. • UT-Houston offers support for implementation of I2B2: • Sharing Best Practices; and/or • Providing Expertise and Support for using I2B2 at each site; or • Hosting an I2B2 application accessing site EMR’s • Other sites may want to use other approaches to the same problem • Will explore the use of Health Information Exchanges and/or local site Informatics approaches.