Post on 29-May-2020
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
Agenda
• Incidence and causes of delays
• Quan8fying the cost of delays
• An8cipa8ng the impact of pa8ent centric ini8a8ves on reducing the cost of delays
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
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
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)
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
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
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
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
Assessing the Impact of Pa8ent Centric Ini8a8ves
Engagement Objec8ve
1. Improved Feasibility 2. Enhanced Convenience 3. Greater Relevance 4. Higher Ownership and Par8cipa8on
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
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
Ken Getz Director, Sponsored Research Programs, Associate Professor
Tuks CSDD, Tuks School of Medicine 617-‐636-‐3487, Kenneth.getz@tuks.edu
Q&A and Thank You!