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Assessment of Risk Benefit

Assessment of Risk Benefit. Jürgen Kübler (presentor) Thorkild Nielsen (facilitator) EFSPI HSM, Berlin, 26 May 2010. Now and Tomorrow. B. B. R. R. Current Positions & Perceptions on Quantitative Benefit-Risk Assessments.

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Assessment of Risk Benefit

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  1. Assessment of Risk Benefit Jürgen Kübler (presentor) Thorkild Nielsen (facilitator) EFSPI HSM, Berlin, 26 May 2010

  2. EFSPI HSM - Benefit-Risk

  3. Now and Tomorrow... B B R R EFSPI HSM - Benefit-Risk

  4. Current Positions & Perceptionson Quantitative Benefit-Risk Assessments • …it cannot replace the rigorous assessment of efficacy and safety individuallyChuang-Stein et al, Drug Inf J 2008 • Quantitative benefit-risk assessment is not expected to replace qualitative evaluationEMEA CHMP, March 2008 • Progress in evaluating benefit:risk will be a function of how quickly the culture of quantitative safety assessment changes in the futureO’Neill, Drug Inf J 2008 EFSPI HSM - Benefit-Risk

  5. IMI Strategic Research Agenda Over 350 senior representatives of patient organisations, universities, hospitals, regulatory authorities as well as small and large biopharmaceutical companies contributed to the elaboration of the IMI Strategic Research Agenda. The IMI Strategic Research Agenda describes the bottlenecks in the biomedical research and development process as: • predicting safety, • predicting efficacy • bridging gaps in knowledge management, and • bridging gaps in education and training Links to benefit-risk assessment EFSPI HSM - Benefit-Risk

  6. Questions to be tackled • Methodological development / consensus on approaches • Population based approaches vs patient preferences • Surrogates vs clinical endpoints • Can we learn from HTA? • Preceived inbalance between efficacy and safety assessments • Can we learn form efficacy assessments • Benefit-Risk management over time EFSPI HSM - Benefit-Risk

  7. Skills Sets in Benefit-Risk • Prospective approaches in safety assessment • ‘Domain’ oriented summary of routine safety data vs. objective (medical question) driven approaches • Observational research versus interventional research • External validity & benefit-risk in ‘real world’ setting • Evidence synthesis • indirect/mixed treatment comparisons • Subgroups/subpopulations of interest • Modelling life-time benefit and harm outcomes • use of surrogate endpoint EFSPI HSM - Benefit-Risk

  8. Suggested Points for Discussion • As a statistical community, how should EFPSI or Professional statistical community engage with the IMI initiative? • How should EFPSI or Professional statistical community link with Academia? • How can EFPSI or Professional statistical community help to develop best practise? EFSPI HSM - Benefit-Risk

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