Best-practices and guidance on the communication of RWE - Annick Moon
3:30 PM - 4:10 PM
Randomized controlled trials are reported in a clinical study report (CSR) that follows regulatory guidelines and provides the data in a standard format. The resulting publication should be an overview of the CSR, with the data communicated according to CONSORT. However, study reports for RWE don’t follow a standard format, meaning that each publication presents novel challenges for the writer. This presentation will explore RWE reporting and discuss how to develop publications for observational studies.
Thomas Wagner, Merck KGaA, Darmstadt, Germany
RWE research does not only differ regarding the objectives of the research and study methodology from classical clinical research, also the way how results should be reported needs to be adjusted to the different content and audience for RWE results.
• Choice of communication instruments
• Using specific RWE nomenclature, not mimicking RCT language
• Targeting RWE specific journals and congresses
• Presenting methodology and results in an appropriate way
• Communicate the value and quality of RWE research
• Tailoring the documents to the respective audience (e.g. clinicians, payers, regulators, patients)
The presentation will give a first introduction about the specifics of writing for RWE studies based on non-interventional studies and database driven research.