The exact dollar amount that third-party investors infuse in U.S. lawsuits every year is unknown, but conservative estimates begin around $2.3 billion, with agreement that the industry has room to grow. With the ongoing pandemic stretching litigation timelines and straining budgets, the litigation funding industry remains highly active. Despite the importance of litigation funding to all parties involved (lawyers, plaintiffs, and defendants), regulation varies by state, and litigation funders are largely left to self-regulate.
The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional.” The FOA relates to the FDA’s RWE Framework published in December 2018, and is issued “to support research projects that examine real-world data (RWD), real-world evidence (RWE), and related issues such as data analytics, the use of digital health tools, and innovative trial designs utilizing healthcare settings.”
The FOA specifically seeks the submission of proposed projects that explore the utility of RWD and RWE in the generation of evidence supporting regulatory approval of new indications of use or post-approval study requirements for approved medicines. The FDA defines RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” RWE is “clinical evidence about the use and potential benefits or risks of a medical product derived from analysis of RWD.”