- Stuart McCully, PhD,,Vice President, Late Stage Support Services, inVentiv Health
- Florian Eichmann, PhD, Principal, Scientific Affairs and Real World Evidence, Late Stage, inVentiv Health
- What do we mean by ‘Real World Evidence’?
- Understand RWE needs of Late Stage stakeholders
- Understand why stakeholders are asking for pragmatic approaches and why they are still rarely performed
- Understand internal / external validity and efficacy vs. effectiveness
- Discuss nuances of pragmatic approaches such as cluster randomization, community based designs, or stepped wedge approaches
- Learn about the regulatory considerations when planning and conducting pragmatic studies
- Understand analytic considerations for evidence validity in pragmatic designs, versus non-interventional approaches using analytic techniques such as regression methods, propensity score matching, instrumental variables.