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Pharmaceutical R&D Process – Why d o Clinical T rials F ail ?

Pharmaceutical R&D Process – Why d o Clinical T rials F ail ?. Erika Buonansegna, PhD Student DTU Management Engineering Supervisors: Søren Salomo , DTU Management Engineering Anja Maier, DTU Management Engineering Jason Li-Ying , DTU Management Engineering

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Pharmaceutical R&D Process – Why d o Clinical T rials F ail ?

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  1. Pharmaceutical R&D Process –Why do Clinical Trials Fail? Erika Buonansegna, PhD Student DTU Management Engineering Supervisors: SørenSalomo, DTU Management Engineering Anja Maier, DTU Management Engineering Jason Li-Ying, DTU Management Engineering Carsten Schultz, Kiel University, Germany Collaborating partner: Medidata Solutions, Inc., New York

  2. gate gate gate gate P.I.R Market Approval Clinical Trials 2

  3. INTRO TO THE PHARMACETICAL R&D: DRUG DISCOVERY AND DEVELOPMENT PROCESS 0.5-2 years 6-7 years 3-6 years Market Approval Clinical Trials 250 5 5.000-10.000 compounds 1 (Efpia, 2011)

  4. CLINICAL TRIAL NETWORK Sponsor Site

  5. CLINICAL TRIAL NETWORK Sponsor CRO Site

  6. CLINICAL TRIAL NETWORK Sponsor CRO Site

  7. RESEARCH MOTIVATION • Few studies on CT failure • Little knowledge on determinants of failure in late development stages • Search for tools to manage CTs Reasons for drug failure (Centre for Medicine Research in Kennedy, 1997) (DiMasi, 2001)

  8. RESEARCH AIM AND QUESTIONS Refine the understanding on failures in clinical trials as a late development stage. Research Questions: • “What causes failure of clinical trials?” • “Can such causes be systematically mapped?” • “Does the assessment of clinical trial failures provide insights into a more general concept of NPD failure during later stages of the development process?”

  9. METHODOLOGY Address clinical trials specificities Literature review Expert study 17 interviews Conceptual framework

  10. Not potential product Potential product CONCEPTUAL FRAMEWORK Completion of a project Termination of a project

  11. MANAGERIAL IMPLICATIONS 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

  12. FUTURE RESEARCH • Clinical trial research • Interdependencies • Ranking according to phases • In-depth case studies • Late development stages in other industries

  13. Erika Buonansegna PhD Student Technical University of Denmark DTU Management Engineering Produktionstorvet, Bygning 426 2800 Kgs. Lyngby Denmark erbou@dtu.dk

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