Real-world evidence should be incorporated throughout all the product’s lifecycle to ensure a significant value during its launch and commercialization. An integrated patient-centric perspective among different stakeholders and a focus on continuous evidence generation is the way forward for the life science industry.
This course will provide methods and hints to successfully:
identify and prioritize the different RWE needs throughout the product lifecycle
apply the observational approach to evaluate “unmet needs” during the clinical development as well as the impact of the drug utilization in the real-world (i.e. patient’s perceptions, effectiveness, safety and benefit in diverse environments and specific patients’ subset)
adopt a multidisciplinary approach to design optimized RWE projects that combine multiple stakeholders needs (i.e. Medical Affairs, Market Access and Clinical Development) to generate clinical evidence aligned with the product strategy and its lifecycle stage
understanding the methodology behind complex statistical methods used for RWE in published scientific papers.
1. Current scenario: introduction to Real World Evidence
2. A practical taxonomy of observational research
3. RWE strategy and study designs
4. Statistics for RWE: sample size and bias
5. Methods for retrospective research
6. Best practices for publishing observational studies
7. Understanding propensity score and its uses in RWE generation
8. Lies, damned lies and… propensity score: controversies
9. Case studies and new applications in RWE
The course is for professionals working in Medical Affairs, Market Access, Drug Development/Clinical Research, Real World Evidence generation, HEOR of pharmaceutical and biotech companies willing to promote, design and manage Real World Evidence project to generate evidence and support the product value.
Some familiarity with biomedical research/drug development is recommended.
Interactive training with practical approach and Q&A sessions.
Statistician and Real World Evidence expert, with a passion for innovation and creativity. Senior consultant with 30+ years’ experience in the pharmaceutical and healthcare sector, providing statistical, scientific and strategic support to leading multinational companies and scientific organizations. Scientific facilitator and trained business coach following the international standards of ICF (International Coach Federation).
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