Comparisons of competing interventions are essential to determine value of medicines, both from clinical and societal perspectives. With head-to-head studies rare, HTA bodies rely on NMA techniques to derive the necessary estimates and incorporate them into cost-effectiveness models. The use of RWD for head-to-head comparison purposes was often challenged due to data limitations and difficulty to draw causal conclusions.
Recently, several research projects have already successfully replicated the results of clinical trials using RWD approaches and recently several life sciences companies supported their regulatory submissions with findings from RWD studies.
Following the well-attended introduction to this series, this second webinar, which will focus on using the approach of emulating target trials to develop head to head comparisons using RWD, continues our investigation of the topic of how to best design and execute these studies, depending on the research questions. This approach can be considered when:
- Generating efficacy or safety evidence for conditional regulatory approval or post-market assessment
- Providing a comparison when network meta analysis is not possible
- Expanding the scope of a randomized trial
- Refining aspects of an existing treatment protocol
- Enabling a comparison to identifying optimal treatment regimes
The specific objectives of this webinar are to:
- Briefly outline the concept of head to head comparison using RWD
- Outline the design of the cardiovascular pilot investigation, including:
- Research question(s) to be addressed
- Specification of the target trial
- Emulation of the target trial
Discuss the data requirements and the data source to be used in the pilot investigation with the focus on how to assess if data are sufficient for the purposes of trial emulation.