PURPOSE: We will provide an overview of challenges of real-world evidence (RWE) for the use in health technology assessment (HTA). We discuss the risk of different potential biases in RWE and the concept of target trial emulation to account for these biases. Three speakers will describe the concept of the target trial emulation, provide examples and challenges of applications of the target trial concept to real-world data and their acceptance in HTA agencies.

DESCRIPTION:

Health Economics and Outcomes Research is generating evidence of the value of an intervention for clinical, payer, or public health decisions using best available data. More and more real-world data are available and can be analyzed to guide such decisions. The focus of this workshop is on discussing how to gain unbiased causal RWE. We concentrate on the target trial emulation concept which provides a counterfactual framework guiding the analysis of observational data. We provide an overview, discuss case examples, and discuss potentials and challenges of the target rial concept. This workshop has four parts:

1. Felicitas Kühne will provide an overview of the target trial concept and how that concept accounts for potential biases occurring in RWE.

2. A speaker that is still to be determined will discuss potentials, expectations, and challenges following of the target trial concept in registry planning and analyses.

3. Uwe Siebert will present case examples of target trial emulations and challenges in the HTA process.

4. We will actively engage participants in the discussion and use polling to collect the audience’s view on discussed issues.