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Following on from part 1 of this webinar series, Ergomed’s Head of RWE and Late Phase Division, Dr Alex Artyomenko plus PrimeVigilance’s Senior Vice President and Head of Pharmacoepidemiology and Risk Management, Dr Michael Forstner and Senior Director Pharmacoepidemiology, Maartje Smulders will discuss real-world research designs, methodological challenges and solutions together with several real-world study case examples.
Randomised controlled trials (RCTs) remain the gold standard for establishing the causal relationship between medication treatment and outcomes.
However, for some clinical questions, RCTs may be unethical, infeasible, too costly, and/or lack generalisability beyond a very narrow population only. In these cases, alternative study designs are crucial for supplementing the evidence from RCTs and providing the required information on the comparative effectiveness and safety of medications.
Pragmatic studies and observational studies collecting and/or assessing real-world data (RWD) can supplement the evidence from RCTs and provide the required information on the comparative effectiveness and safety of medications. However, concerns about the validity of real-world studies continue to detract from their utility for decision-making.
In this webinar, we will summarise key considerations – study design, methodological approach and tools – which stakeholders should consider when designing or evaluating real-world studies. All portrayed along with practical case examples of studies.
We will be discussing:
The webinar will be followed by a Q&A session where you will be able to ask questions and receive direct feedback on key areas of uncertainty.