RE: First target18 Dec 2024 13:58
The Linkedin post refers to the appointment of Dr Mark Davies In November :
''Mark’s expertise enhances our ability to deliver critical insights, while his creative approach to solving complex drug development challenges – including the use of real-world data (RWD) – brings new opportunities for advancing innovation''
The FDA issued a release on 1st October, 2024 relating to the use of RWD. Here is an extract :-
FDA has a long history of using what we currently call real-world data (RWD) and real-world evidence (RWE) to monitor and evaluate the post market safety of approved drugs. RWE has also been used historically to support effectiveness, but on a more limited basis. Advances in the availability and analysis of RWD have increased the potential for generating robust RWE to support FDA regulatory decisions.
FDA is committed to realizing the full potential of fit-for-purpose RWD to generate RWE that will advance the development of therapeutic products and strengthen regulatory oversight of medical products across their lifecycle.
Real-world data are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. Real-world evidence is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.
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