TheCostofClinicalTrialDelaysOverallDrugDevelopmentDuraons...
Transcript of TheCostofClinicalTrialDelaysOverallDrugDevelopmentDuraons...
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The Cost of Clinical Trial Delays
Ken Getz Director, Sponsored Research Programs, Associate Professor
Tu<s CSDD, Tu<s University School of Medicine
January 2015
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Agenda
• Incidence and causes of delays
• Quan8fying the cost of delays
• An8cipa8ng the impact of pa8ent centric ini8a8ves on reducing the cost of delays
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Overall Drug Development Dura8ons (Cycle Time in Years from IND Approval to NDA Approval)
6.3 6.8 7.2 5.9 6.0 6.1 6.3 6.8 6.7
2.9 2.6 2
1.4 1.2 1.75 1.6 1.5 1.4
87-‐89 90-‐92 93-‐95 96-‐98 99-‐01 02-‐04 05-‐07 08-‐10 11-‐13
Mean Clinical Time Mean Approval Time
Source: Tufts, CSDD
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Actual Enrollment Timelines Typically Double Planned Timelines
116.0%
113.0%
99.0%
95.0%
71.0%
94.0%
CNS
Endocrine/Metabolic
Cardiovascular
Respiratory
Oncology
OVERALL
Planned Actual
Source: Tu<s CSDD, 2012
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Inves8ga8ve Site Enrollment Achievement
Fail to Enroll a Single Pa8ent 11%
Under Enroll 37%
Meet Enrollment Targets 39%
Well Exceed Enrollment Targets
13%
Source: Tu<s CSDD, 2012
(N= 15,965 sites par8cipa8ng in 153 global phase II and III clinical trials)
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Increasing Protocol Complexity
A Typical Phase III Protocol 2002 2012
Scien8fic Total Number of Endpoints 7 13
Total Number of Procedures 106 167
Propor8on of Procedures that are ‘Non Core’ 18% 31%
Total Number of Eligibility Criteria 31 50
Opera8ng Total Number of Countries 11 34
Total Number of Inves8ga8ve sites 124 196
Source: Tufts CSDD
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Delays Associated with Complexity (All TAs, Phases II-‐III)
Most Complex Protocols
Study volunteer screen to comple8on rate -‐50%
Time from Protocol Ready to FPFV (median) +12%
Time from Protocol Ready to LPLV (median) +73%
Number of Amendments +68%
Source: Tufts CSDD, 2013 7
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Capitalized Cost to Develop an Approved New Drug has More than Doubled
$1,044
$2,558
2003 2013
($US millions expressed in 2013 dollars)
Source: Tu<s CSDD
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Peeling Apart Direct and Capitalized Costs
DIRECT COSTS CAPITALIZED COSTS Difference
Basic Research through Preclinical
$237 million $358 million 51%
Clinical through Regulatory Approval
$474 million $560 million 18%
Allocated Failures $684 million $1.6 billion 134%
TOTAL per APPROVED DRUG $1.4 billion $2.6 billion
Source: Tu<s CSDD
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Assessing the Impact of Pa8ent Centric Ini8a8ves
Engagement Objec8ve
1. Improved Feasibility 2. Enhanced Convenience 3. Greater Relevance 4. Higher Ownership and Par8cipa8on
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The Impact of Pa8ent Centric Ini8a8ves
Engagement Objec8ve
Outcome
Feasibility Speed and Efficiency; Success Rates
Convenience Speed and Efficiency
Relevance Speed and Efficiency; Success Rates
Ownership and Par8cipa8on
Speed and Efficiency
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Quan8fying Impact (Savings on Capitalized Costs in 2013 $s)
Level of Improvement Cycle Time Success Rate
5% $102 million $153 million
10% $250 million $384 million
25% $390 million $486 million
Source: Tu<s CSDD
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Ken Getz Director, Sponsored Research Programs, Associate Professor
Tuks CSDD, Tuks School of Medicine 617-‐636-‐3487, [email protected]
Q&A and Thank You!