On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, respectively) released a “discussion draft” of bipartisan legislation—the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”)—which contains notable provisions related to digital health.
Real World Evidence
Reps. DeGette and Upton Release Highly-Anticipated “Cures 2.0” Draft
On June 22, 2021, Congressional leaders Diana DeGette (D-DO) and Fred Upton (R-MI) released a bipartisan follow-up to the 2016 21st Century Cures Act. “Cures 2.0”—a “discussion draft” at this stage—is intended to build upon the Cures Act. The draft lays out several notable policies related to digital health, real-world data/evidence (RWD/E), and…
FDA Announces Public Workshop on Using Randomized Clinical Trials to Generate Real-World Evidence
Today, FDA published a notice in the Federal Register announcing a public workshop on July 11-12 entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” This workshop builds on FDA’s ongoing efforts to implement the Real-World Evidence (RWE) Framework published in December 2018, which we previously discussed in this post.
EMA publishes “A Common Data Model for Europe? – Why? Which? How?” Workshop Report
On 8 October, the European Medicines Agency (EMA) published a report (available here) setting out the progress it has made towards applying a common data model (CDM) in Europe. The EMA defines a CDM as “a mechanism by which raw data are standardized to a common structure, format and terminology independently from any particular study in order to allow a combined analysis across several databases/datasets”. The report follows an EMA-hosted workshop in December 2017 to examine the opportunities and challenges of developing a CDM.
The report acknowledges that the use of ‘Real World Data’ (RWD) (data relating to patient health status or delivery of health care data that is routinely collected from sources other than clinical trials) has become an increasingly common source of evidence to support drug development and regulatory decision making for human medical use in Europe. However, Europe currently has no pan-European data network, despite the wealth of data generated through various national healthcare systems that provide access for all. Many multi-database studies currently performed are typically slow and still allow for substantial variability in the conduct of studies. Further, there are a growing number of innovative products that no longer align with customary drug development pathways. This may create uncertainty in their data packages required for authorization, and subsequent tension between facilitating earlier access for patients with limited treatment options against the requirement for proactive robust pharmacovigilance of medicines for wider clinical use across the product life cycle (the existing EMA Patient Registry Initiative addresses this need in part).
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