Real-world data (RWD) and Real-world evidence (RWE) are buzz words within biopharma, medical device and clinical research organizations. The recently issued FDA’s Real-World Evidence Program Framework further contributed to broaden the interest in RWE well beyond Heath Economics and Outcomes Research (HEOR) and Epidemiology professionals.
However, one of the key pre-requisites of the RWE is to share a common understanding of the terminology. Furthermore, the importance of understanding the variety of methodological approaches and what they entail is sometimes underestimated. RWE refers to data extracted from very diverse sources such as electronic health records (EHRs), claims and administrative data, disease or drugs registries, Patients Reported Outcomes (PROs), prospective observational studies, data collected via wearable devices and so on. These alternative sources of data may be complementary (and not competitive) ways to the knowledge acquired through traditional clinical trials and can be considered as an additional source to overcome the well-known limitations of clinical programs (e.g. generalizability).
In this introduction to the Epiforum 2019 meeting, we will go beyond the buzz words and describe the objective of the meting i.e. how RWD can provide decision-makers with supporting evidence to inform decision on therapeutics development, comparative effectiveness, outcomes research, impact on health care systems of new therapies, health care quality, safety, patients adherence and preferences, etc.
This short introduction to the meeting will help in clarifying important notions and definitions and willprovide a framework to the following presentations.
Michele Intorcia is currently Health Economics Outcomes Research (HEOR) CoE Head at Vifor Pharma. He holds a Master Degree from London School of Economics in International Health Policy and worked in Public Health and Academia. With 15 years experience in the Pharmaceutical Industry he formerly worked for Bristol Myers Squibb and Amgen. He focuses on the evidence generation and pharmacoeconomics strategy to secure access and reimbursement for innovative drugs.