“Generating Credible RWE to Affect Decision Making” is the topic at this evening’s MAPS APAC Virtual Summit. The key note speaker, Brian Bradbury, is discussing the emerging RWE landscape.
Population data are foundational for helping to understand the distribution and determinants of disease.
Real World Data is derived from a variety of sources eg connected devices, medical imaging, clinical text, social media, literature, genomics, patient reported outcomes, clinical studies, pharmacy, medical claims, electronic medical records, disease and product registries.
Real World Evidence is clinical evidence regarding the usage and potential benefits or risks, of a medical product derived from analysis of RWD.
RWE provides an important complement to the evidence gleaned from randomised trials, because populations studies in controlled trials tend to be homogenous and often different from those observed in clinical practice.
RWE has been used by regulatory agencies to evaluate the safety of medicines.
There is increasing openness by global regulators to use of RWD/RWE to support regulatory submissions.
There are emerging standards and best practices for the use of RWE to support (regulatory) decision-making.
The guiding principles for generating RWE include:
Understanding the strengths and limitations of your data.
Conducting feasibility analyses.
Comprehensive designing then analysing
Developing research protocols to govern research
Conducting sensitivity/bias analyses to test robustness of findings.
Acceptance of RWE by stakeholders across the healthcare ecosystem continues to mature.
RWE-based approached can reliably address a wide range of healthcare questions.
Generating credible RWE requires a principled and transparent approach to study design and analysis.
High quality, fit-for-purpose RWE can help inform on the benefits and risks of therapeutic interventions.
Victoria Elegant, Vice President, Region Head Amgen
Alan McDougall, Vice President and Head of Medical Affairs,
International Markets and Greater China at Astellas Europe
Brian Bradbury, Vice President, Center for Observational
Research at Amgen
HPG (Healthcare Professionals Group)
Sydney (02) 8877 8777
Melbourne (03) 9938 7100
#MedicalAffairs #MSL #RWE #RealWorldEvidence #drugdevelopment #pharmaceuticals #biotechnology