pharmaceutical r&d process – why do clinical trials fail? erika buonansegna, phd student dtu...
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Pharmaceutical R&D Process –Why do Clinical Trials Fail?
Erika Buonansegna, PhD StudentDTU Management Engineering
Supervisors:Søren Salomo, DTU Management EngineeringAnja Maier, DTU Management EngineeringJason Li-Ying, DTU Management EngineeringCarsten Schultz, Kiel University, Germany
Collaborating partner:Medidata Solutions, Inc., New York
Idea generation and evaluation
Concept development and product
planning
Prototype development
Test of the prototype
Production and Market
Introduction
Research & Drug
Discovery
Preclinical Studies Phase I Phase II Phase III
Test of the prototype
(Cooper, 1994)
Market Approval
gate gate gategate
Clinical Trials
P.I.R
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3
Research & Drug
Discovery
Preclinical Studies Phase I Phase II Phase III
INTRO TO THE PHARMACETICAL R&D: DRUG DISCOVERY AND DEVELOPMENT PROCESS
6-7 years3-6 years 0.5-2 years
5.000-10.000 compounds
250 5 1
(Efpia, 2011)
Market Approval
Clinical Trials
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CLINICAL TRIAL NETWORK
Sponsor
Site
5
CLINICAL TRIAL NETWORK
CRO
Sponsor
Site
6
CLINICAL TRIAL NETWORK
CRO
Sponsor
Site
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• Few studies on CT failure• Little knowledge on determinants of failure in late development
stages• Search for tools to manage CTs
(Centre for Medicine Research in Kennedy, 1997) (DiMasi, 2001)
Reasons for drug failure
lack of ef-ficiency
46%
toxicity17%
commercial reasons
7%
miscellaneous7% pharma-
cokinetics7%
adverse events 16% lack of efficiency
37%
lack of safety20%
commercial reasons34%
miscellaneous9%
RESEARCH MOTIVATION
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Refine the understanding on failures in clinical trials as a late development stage.
Research Questions:(1) “What causes failure of clinical trials?”(2) “Can such causes be systematically mapped?” (3) “Does the assessment of clinical trial failures provide insights
into a more general concept of NPD failure during later stages of the development process?”
RESEARCH AIM AND QUESTIONS
Address clinical trials specificities
Expert study 17 interviews
Literature review
Conceptual framework
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METHODOLOGY
Success False-positive failures-Difficult subject recruitment for testing-Lack of experience in choosing and monitoring the partners-Lack of feasibility of the testing procedure-High demand for documentation -Many incidents while testing-Unmanageable level of portfolio complexity -Incorrect assessment of the market potential or returns
False-negative failures-Difficult subject recruitment for testing-Lack of experience in choosing and monitoring the partners-Lack of feasibility of the testing procedure-High demand for documentation -Many incidents while testing-Unmanageable level of portfolio complexity -Incorrect assessment of the market potential or returns
Inevitable failures-Toxicity-Lack of efficacy-Economics
Term
inati
on
of a
pro
ject
Potential product Not potential product
Com
pleti
on
of a
pro
ject
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CONCEPTUAL FRAMEWORK
Proactive strategies• Improving skills of the development team• Due diligence in choosing sites and subcontractors• E-recruitment tactics• Monitoring sites and subcontractors• Interim and risk analyses• Training for SAEs• Feedback from investigators
Reactive strategies• Fast reallocation of resources• Back-up candidates and parallel-track strategy• Learning-by-failing mind set
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MANAGERIAL IMPLICATIONS
• Clinical trial research – Interdependencies– Ranking according to phases– In-depth case studies
• Late development stages in other industries
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FUTURE RESEARCH
Erika BuonansegnaPhD Student
Technical University of DenmarkDTU Management EngineeringProduktionstorvet, Bygning 4262800 Kgs. LyngbyDenmarkerbou@dtu.dk
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