Regulatory bodies are increasingly considering the expanded usefulness of Real-World Data (RWD) and Real-World Evidence (RWE).
What are RWD and RWE?
There is a growing need to understand RWD and RWE due to recent trends, and scientific and analytical advances within the space.
The United States Food and Drug Administration (FDA) define RWD as:
"The data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources."
Additionally, the FDA label RWE as:
"Clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD."
The FDA’s full definitions of RWD and RWE, and a list of additional resources can be found here.
Essentially, RWD and RWE should be viewed as information and resultant analysis drawn from sources beyond orthodox Randomised Clinical Trials (RCT).
Beyond Safety Monitoring
Proponents argue RWD and RWE are useful in contexts beyond post-market safety monitoring – specifically in assessing efficacy.
In a recent article, published in Clinical Pharmacology and Therapeutics, Arlett et al. advocate for the use of RWD and RWE in assessing efficacy alongside traditional RCT.
Writing to proposed European Union (EU) priorities, Arlett et al. stress:
"[A]cknowledging different frameworks to conceptualize the challenges and opportunities of RWE, we believe the two main priorities for the European Union are to enable its use and establish its value for regulatory decision making."
From this literature, and consequent acknowledgement by the EMA, there appears to be a bright future for the use of RWD and RWE in assessing the efficacy of medical products.
As such, it is important for suppliers and manufacturers worldwide to stay informed on developments concerning RWD and RWE, and their growing role in assessing medical product efficacy.
Regardless of regulatory requirements, Komply can help you prove your product’s efficacy to relevant authorities.
Komply advises and assists clients in end-to-end quality assurance, registration, regulatory, compliance, and commercialisation matters in human and veterinary applications.
Contact us directly at info@komplyaus.com for more information.
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