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.