The Role Of Patient Advocacy Organizations In Regulatory Best Practice

14 Sep 2022

The most recent FDA guidance on the use of real-world data in regulatory decision making is fundamental for patient advocacy organizations, ensuring that the FDA endorses drugs or biological products that lead to proper health outcomes without the risk of life-threatening side effects.

The ability to capture the full view of a patient’s health history, including their personal experience, is essential to improving medical outcomes and ensuring therapeutic discoveries meet patient needs. While there is a rich repository of patient information from sources like registries and electronic health records, there have been longstanding hurdles to utilizing the data to improve health outcomes, such as the lack of consistent data standards, integrated digitalization of health records, and blocking of data sharing by certain parties.

Luckily, these challenges are the focus of recent health data regulations and are being addressed with the implementation of the...