Pharma Advances recently published “Expert opinion on Real-World Evidence (RWE) in drug development and usage” co-authored by Dr. Luca Pani, VP Regulatory Strategy and Market Access Innovation at VeraSci. This article presents the Italian Society of Pharmacology’s expert opinion on RWE as a technical-scientific reference for institutions, the scientific community, health care professionals, and pharmaceutical companies.
Randomized clinical trials are the gold standard for assessing the safety and efficacy of treatments. Still, they come with limitations that make their results difficult to generalize to the entire treatment population. RWE, information collected through routine clinical practice, offers opportunities in both the pre-marketing and post-marketing phases to provide valuable information. In the pre-marketing phase, RWE can provide insight into disease burden and unmet medical needs. In the post marketing phase, RWE can contribute to comparative effectiveness research, drug safety information, and more. RWE also has the potential to play an important role in innovative pricing and reimbursement models. Read the full article here.