TheCostofClinicalTrialDelaysOverallDrugDevelopmentDuraons...

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!