1
Activating & Opening
Oncology Clinical Trials:
A Process & Timing Study
David M. Dilts, PhD, MBA
Director & Professor, E...
2
Thank you to the study sites
3
Method
Part I: Process Mapping
• Extensive visits at each site to document processes, loops and decisions:
• Say…..: Wha...
31.6 ft x 3.5 ft in 8pt font
37.1 ft x 3.5 ft in 8pt font
CCC-1
CCC-2
Detailed Process Maps
4
5
Process Counts
Comprehensive Cancer Centers
CCC-1* CCC-2 CCC-3 CCC-4
Process Steps 117 374 345
…Working Steps 64 292 272...
6
Activation & Opening Time Phase III
Cooperative Group Trials
@ Cooperative Groups and Comprehensive Cancer Centers (CCC)...
7
Days from Concept to Open
Investigator Initiated Trials (IIT)
Comprehensive
Cancer Center
n Median Min Max
CCC-1 37 211 ...
8
Total Processes to Open a
Cooperative Group Study
Cooperative Group Processes
Median: 116 to 252 days*
Range: 21-836 day...
9
Example Of The Flow: E1301
Concept Review
Days
Protocol Review
Days
Total Days
Study Chair 49 122 171
Cooperative Group ...
10
0
200
400
600
800
1000
1200
1400
1600
1800
2000
Study
TotalDays Time From Concept Receipt to Activation
Phase III Thera...
11
Actual Accrual Per Trial Ranges
Comprehensive Cancer Centers
Accrual Per
Trial
CCC-1 CCC-2 CCC-3 CCC-4
0 20.6% 25.7% 27...
ECOG Phase III Accrual Performance
•All phase III studies activated and closed to accrual between 1/2000 – 7/2006
•Color C...
13
Initial Quick-Fix
Recommendations
• Immediately start collecting & analyzing data
• “Just Say No”
• Eliminate “entitlem...
Current
Simulation
Cooperative
Group
Improvement
CTEP
Improvements
CTEP and
Cooperative
Group
Improvements
Description As-...
15
Initial Long Term
Recommendations
• Start with a clean sheet of paper
• Develop and utilize standards
• i.e., vary in c...
16
Next Steps
• NCI intramural clinical trials program being studied
• CTAC Working Group forming
– Results have been pres...
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  1. 1. 1 Activating & Opening Oncology Clinical Trials: A Process & Timing Study David M. Dilts, PhD, MBA Director & Professor, Engineering Management Program, School of Engineering Professor, Owen Graduate School of Management Co-Director, Center for Management Research in Healthcare (cMRHc.org) Alan B. Sandler, MD Associate Professor of Medicine, Division of Hematology/Oncology Medical Director, Thoracic Oncology Program Director, Vanderbilt-Ingram Cancer Center Affiliates Network Co-Director, Center for Management Research in Healthcare (cMRHc.org)
  2. 2. 2 Thank you to the study sites
  3. 3. 3 Method Part I: Process Mapping • Extensive visits at each site to document processes, loops and decisions: • Say…..: What they say they do • Should: What policies and procedures say they should do • Do…...: What study chart reviews show they actually do • Creation of process map Part II: Process Timing • Identify calendar time for total process and major steps, and potential influencers of the time Part III: Accrual Data • Investigate actual accrual results of the studies • Dilts DM and Sandler AB (2006) “The Invisible Barriers to Opening Clinical Trials, J Clinical Oncology, 24(28): 4545-52 • Dilts DM, Sandler AB et al. (2006) “Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B,” J Clinical Oncology, 24(28): 4553-57.
  4. 4. 31.6 ft x 3.5 ft in 8pt font 37.1 ft x 3.5 ft in 8pt font CCC-1 CCC-2 Detailed Process Maps 4
  5. 5. 5 Process Counts Comprehensive Cancer Centers CCC-1* CCC-2 CCC-3 CCC-4 Process Steps 117 374 345 …Working Steps 64 292 272 …Decision Points 53 61 62 …Processing Loops - 31 27 Stopping Points 19 21 11 Process Steps by Type of Trial Investigator Initiated - 180 234 NCI Initiated - 131 n/a Cooperative Group Initiated - 77 74 Industry Initiated - 144 169 ProcessCounts
  6. 6. 6 Activation & Opening Time Phase III Cooperative Group Trials @ Cooperative Groups and Comprehensive Cancer Centers (CCC) n Median Min Max CALGB 13 784 537 1130 ECOG 28 808 435 1604 CCC- 1 58 120 27 657 CCC- 2 3 252 139 315 CCC- 3 4 122 81 179 CCC- 4 178 116 21 836 • Notes: • Receipt by Group or AMC to activation or opening • Time is calendar days, not work days • These are lower bounds because only survivors were investigated • Total time to open a study is the addition of Group time + CCC time
  7. 7. 7 Days from Concept to Open Investigator Initiated Trials (IIT) Comprehensive Cancer Center n Median Min Max CCC-1 37 211 113 498 CCC-2 9 315 139 541 CCC-3 5 451 230 750 CCC-4 25 243 107 908
  8. 8. 8 Total Processes to Open a Cooperative Group Study Cooperative Group Processes Median: 116 to 252 days* Range: 21-836 days Median: 784 to 808 days* Range: 435-1604 days Comprehensive Cancer Center Processes * Depending Upon Site, based on the Phase III trials studied
  9. 9. 9 Example Of The Flow: E1301 Concept Review Days Protocol Review Days Total Days Study Chair 49 122 171 Cooperative Group 59 340 399 CTEP 98 184 282 CIRB n/a 123 123 Total 206 769 975
  10. 10. 10 0 200 400 600 800 1000 1200 1400 1600 1800 2000 Study TotalDays Time From Concept Receipt to Activation Phase III Therapeutic Studies activated through CTEP 1/2000 – 6/2007† By year 2000 2001 2002 2003 2004 2005 2006 2007
  11. 11. 11 Actual Accrual Per Trial Ranges Comprehensive Cancer Centers Accrual Per Trial CCC-1 CCC-2 CCC-3 CCC-4 0 20.6% 25.7% 27.7% 34.4% 1-4 33.0% 32.3% 30.3% 31.3% 5-10 19.3% 16.1% 22.7% 18.0% 11-15 11.0% 7.3% 8.4% 4.3% 16-20 3.7% 3.7% 3.4% 5.3% >20 12.4% 15.0% 7.6% 6.8%
  12. 12. ECOG Phase III Accrual Performance •All phase III studies activated and closed to accrual between 1/2000 – 7/2006 •Color Code: • red : studies taking greater than the median time to open • blue: studies taking less than the median time to open • gray: studies closed due to reasons other than poor accrual
  13. 13. 13 Initial Quick-Fix Recommendations • Immediately start collecting & analyzing data • “Just Say No” • Eliminate “entitlement culture” • Stop tweaking • “Two strikes and you’re out” • Say what you mean & mean what you say
  14. 14. Current Simulation Cooperative Group Improvement CTEP Improvements CTEP and Cooperative Group Improvements Description As-Is performance Improved Selective Study Criteria Improved Review Performance Simultaneous Improvments n* 99 103 108 121 mean 837.29 791.51 653.01 252.78 min 222 209.07 214.93 214.35 max 3857.89 3576.71 4292.98 311.96 st. dev 760.75 729.3 670.63 24.14 Timing Distribution * Simulation period defined over a period of 5 years (1825 Calendar Days) * Note: Axes on the Timing Distribution Graphs are different Simulation Results
  15. 15. 15 Initial Long Term Recommendations • Start with a clean sheet of paper • Develop and utilize standards • i.e., vary in critical scientific issues, not in administrative processes • Use Focused Phase III Teams
  16. 16. 16 Next Steps • NCI intramural clinical trials program being studied • CTAC Working Group forming – Results have been presented to Cancer Centers and Cooperative Groups – Collaboration and participation in the Working Group solicited • Goal – cut clinical trial activation time in half
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