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# How to Expand RWE in Drug Decisions: Study
- URL: https://www.fdaweb.com/how-to-expand-rwe-in-drug-decisions-study/
- Published: 2019-08-22T12:00:00.000Z
- Updated: 2026-09-15T01:45:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144827

The Bipartisan Policy Center, which includes former FDA commissioners **Robert Califf**, **Andrew von Eschenbach**, and **Mark McClellan** on its leadership team, has issued a report with recommendations for expanding the use of real-world evidence (RWE) in regulatory and value-based payment decision-making for drugs and biologics. In an introduction to the [report](https://bipartisanpolicy.org/wp-content/uploads/2019/08/Health%5FInnovation%5FReal-World%5FEvidence%5FReport%5FR04.pdf?ref=fdaweb.com), the three say that significant progress already has been made in creating a framework for use of RWE in regulatory decision-making, but there is more work to do. “This report examines both the progress so far and the barriers we must address if we are to meaningfully expand the role of real-world data and evidence to inform the discovery, development, and delivery of new therapies for patients, provide high-quality evidence about risks and benefits in practice, and inform which therapies are best for which patients,” they write.

The report’s recommendations are: 

- assure adequate funding of RWE activities;
- improve regulatory clarity;
- improve access to data;
- improve reliability and relevance of data;
- leverage technology to gain input directly from patients;
- expand efforts to leverage artificial intelligence;
- accelerate pilots and demonstration projects for new data sources and additional medical products;
- assure privacy and confidentiality;
- advance innovative, new models of drug development;
- address regulatory barriers;
- expand the Centers for Medicare and Medicaid Services workforce to support evaluation of new emerging therapies; and
- promote cooperation and collaboration.

Under each of the 12 recommendations is one or more implementation steps.

“We are living in an age of remarkable scientific progress,” the former commissioners conclude. “We owe it to the patients we serve to support that progress by continually examining and improving our processes to deliver new, effective therapies to them as fast as safely possible. We believe the recommendations in this report are important steps toward reaching that critical goal.”