Strategic Development and Expansion of the Clinical Trials Infrastructure Lynne Chronister Assistant Vice Provost Universi...
<ul><li>Are we  </li></ul><ul><li>Missing </li></ul><ul><li>something </li></ul><ul><li>Here? </li></ul>
GOALS <ul><li>Improve the Quality of the Clinical Trials. </li></ul><ul><ul><ul><ul><ul><li>AND/OR </li></ul></ul></ul></u...
Session Objectives <ul><li>Identify Non-clinical Components Needed for Building and Sustaining a  Successful Clinical Tria...
Examples <ul><li>University of California, Davis </li></ul><ul><li>University of Washington </li></ul>
1. What Do we Need to be Successful <ul><li>Leadership </li></ul><ul><li>Infrastructure </li></ul><ul><li>Appropriate Staf...
Leadership <ul><li>One of the most critical components to enhancing or improving the clinical trials program is the commit...
Infrastructure <ul><li>Budgeting Office </li></ul><ul><li>Sponsored Programs </li></ul><ul><li>Anatomical Specimens/Human ...
Appropriate Staffing <ul><li>Clinical Trials Office? </li></ul><ul><li>Budgeting </li></ul><ul><li>Negotiations </li></ul>...
Processes <ul><li>Internal approval of clinical trials </li></ul><ul><li>Budgeting of Clinical trial costs </li></ul><ul><...
Policies and Practices <ul><li>Policy on Gifts  </li></ul><ul><li>Policy on indirect cost </li></ul><ul><li>Policy on Conf...
Standard Definitions <ul><li>What is a clinical trial? </li></ul><ul><li>“Clinical trials are voluntary research studies, ...
2. Tools we can Use to Get There <ul><li>Process Chart </li></ul><ul><li>Gap Analysis </li></ul><ul><li>Roadmap </li></ul>
Flow Diagrams <ul><li>The first step in any process is to figure out the current process and map it out thoroughly. </li><...
 
 
 
 
 
 
 
 
 
 
 
 
 
Example Other Relevant Information Program Models (website)  Target Audience for Training Is Training Required by Internal...
Gap Analysis <ul><li>An assessment tool to identify the gap between actual performance to preferred performance achievemen...
Gaps  <ul><li>Clinical Trial Model  Clinical Trial Actual   </li></ul><ul><li>30 days to complete 200 days to complete </l...
Gap Analysis <ul><li>Use visioning to identify where the group wants to be at a specific time and post on one side of the ...
Stanford Responsibility Chart
Roadmap <ul><li>In order to get where you need to know –it is much easier if you know where you are going and the route yo...
Roadmapping <ul><li>Activity  Finish Date  Responsible Party  Done </li></ul>
Contact Information <ul><li>Lynne Chronister </li></ul><ul><li>Assistant Vice Provost and </li></ul><ul><li>Director of Sp...
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Strategic Development and Expansion of the Clinical Trials Infrastructure

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The goal is to improve the quality of the clinical trials and increase the number of clinical trials.

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Strategic Development and Expansion of the Clinical Trials Infrastructure

  1. 1. Strategic Development and Expansion of the Clinical Trials Infrastructure Lynne Chronister Assistant Vice Provost University of Washington
  2. 2. <ul><li>Are we </li></ul><ul><li>Missing </li></ul><ul><li>something </li></ul><ul><li>Here? </li></ul>
  3. 3. GOALS <ul><li>Improve the Quality of the Clinical Trials. </li></ul><ul><ul><ul><ul><ul><li>AND/OR </li></ul></ul></ul></ul></ul><ul><li>Increase the Number of Clinical Trials. </li></ul>
  4. 4. Session Objectives <ul><li>Identify Non-clinical Components Needed for Building and Sustaining a Successful Clinical Trials Program </li></ul><ul><li>Look at Tools That can be used to Reach identified Goals and Outcomes </li></ul>
  5. 5. Examples <ul><li>University of California, Davis </li></ul><ul><li>University of Washington </li></ul>
  6. 6. 1. What Do we Need to be Successful <ul><li>Leadership </li></ul><ul><li>Infrastructure </li></ul><ul><li>Appropriate Staffing </li></ul><ul><li>Effective and Efficient Processes </li></ul><ul><li>Policies and Practices </li></ul>
  7. 7. Leadership <ul><li>One of the most critical components to enhancing or improving the clinical trials program is the commitment and engagement of senior leadership. </li></ul>
  8. 8. Infrastructure <ul><li>Budgeting Office </li></ul><ul><li>Sponsored Programs </li></ul><ul><li>Anatomical Specimens/Human Tissue </li></ul><ul><li>Environmental Health/Safety </li></ul><ul><li>Compliance/IRB/Conflict of Interest/HIPAA </li></ul><ul><li>Account Payables </li></ul><ul><li>General Counsel </li></ul><ul><li>Risk Management/Insurance </li></ul><ul><li>Clinical Trials Office/Clinical Study Coordinators </li></ul><ul><li>Industry Relations </li></ul><ul><li>Medical Records(electronic record of participation) </li></ul>
  9. 9. Appropriate Staffing <ul><li>Clinical Trials Office? </li></ul><ul><li>Budgeting </li></ul><ul><li>Negotiations </li></ul><ul><li>Facilitation </li></ul><ul><li>Compliance </li></ul><ul><li>Billing </li></ul><ul><li>Regulatory </li></ul>
  10. 10. Processes <ul><li>Internal approval of clinical trials </li></ul><ul><li>Budgeting of Clinical trial costs </li></ul><ul><li>Invoicing for clinical trials </li></ul><ul><li>Ensuring no invoicing for standard of Care </li></ul><ul><li>Good Clinical Practices </li></ul><ul><li>Training: </li></ul><ul><li>Investigators </li></ul><ul><li>Coordinators </li></ul>
  11. 11. Policies and Practices <ul><li>Policy on Gifts </li></ul><ul><li>Policy on indirect cost </li></ul><ul><li>Policy on Conflict of Interest </li></ul><ul><li>Policy on who can be a “PI” </li></ul><ul><li>Policy on who can consent </li></ul><ul><li>Policy on Training </li></ul><ul><li>Policy on Data Safety and Monitoring </li></ul><ul><li>Policy on use of Residual Funds </li></ul>
  12. 12. Standard Definitions <ul><li>What is a clinical trial? </li></ul><ul><li>“Clinical trials are voluntary research studies, conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments” </li></ul><ul><li>FDA </li></ul>
  13. 13. 2. Tools we can Use to Get There <ul><li>Process Chart </li></ul><ul><li>Gap Analysis </li></ul><ul><li>Roadmap </li></ul>
  14. 14. Flow Diagrams <ul><li>The first step in any process is to figure out the current process and map it out thoroughly. </li></ul>
  15. 28. Example Other Relevant Information Program Models (website) Target Audience for Training Is Training Required by Internal Policy Is Training Currently Available and Adequate Is Training Required by External Regulations? Is there an Oversight Committee (Chair)? If so, who? Who is Accountable for Campus Enforcement and Discipline? Who is Responsible for Monitoring and Auditing Who is Accountable for Operational Compliance? What is the Applicable Current UC Policy? If it exists, does it need to be revised/updated? Is a Policy Needed or Required? Applicable Regulations, Policies, Guidelines and Accrediting Bodies/Requirements Billing human subjects/payors GRANT MANAGEMENT
  16. 29. Gap Analysis <ul><li>An assessment tool to identify the gap between actual performance to preferred performance achievements </li></ul><ul><li>Or </li></ul><ul><li>An assessment tool comparing a groups’ current activities with what they should be doing. </li></ul>
  17. 30. Gaps <ul><li>Clinical Trial Model Clinical Trial Actual </li></ul><ul><li>30 days to complete 200 days to complete </li></ul><ul><li>Concurrent IRB review Consecutive Review </li></ul><ul><li>40 days IRB turnaround 120 days turnaround </li></ul>
  18. 31. Gap Analysis <ul><li>Use visioning to identify where the group wants to be at a specific time and post on one side of the wall </li></ul><ul><li>Identify the present state and post the details on the opposite wall </li></ul><ul><li>Instruct the group to work with partners to identify the gaps </li></ul><ul><li>Share the ideas/gaps as a group and post on the wall between the other two lists </li></ul><ul><li>Reach consensus on the gaps and reassemble the whole group to hear recommendations and action plans </li></ul><ul><li>Create a means for follow-up </li></ul><ul><li>(L+M) Consulting </li></ul>
  19. 32. Stanford Responsibility Chart
  20. 33. Roadmap <ul><li>In order to get where you need to know –it is much easier if you know where you are going and the route you are taking! </li></ul>
  21. 34. Roadmapping <ul><li>Activity Finish Date Responsible Party Done </li></ul>
  22. 35. Contact Information <ul><li>Lynne Chronister </li></ul><ul><li>Assistant Vice Provost and </li></ul><ul><li>Director of Sponsored Programs </li></ul><ul><li>206-543-4043 </li></ul><ul><li>[email_address] </li></ul>

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