> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Report Recommends ‘Real World’ Evidence Programs for FDA
- URL: https://www.fdaweb.com/report-recommends-real-world-evidence-programs-for-fda/
- Published: 2016-06-24T12:00:00.000Z
- Updated: 2026-09-14T21:11:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136043

The Bipartisan Policy Center has issued a [new report](http://cdn.bipartisanpolicy.org/wp-content/uploads/2016/06/BPC-Health-Innovation-Safe-Effective-Cures.pdf?ref=fdaweb.com) on “Using Real-World Evidence to Accelerate Safe and Effective Cures” that offers recommendations for FDA to help advance medical innovation. “Real-world evidence can play a significant role in modernizing the drug approval process in the United States,” the report says. “The increase in the amount of electronic data available, combined with scientific advances resulting in more personalized and more complex drug regimens, demand a new, modernized approach that spans the entire drug life-cycle. Implementing the steps outlined in this report will enable the United States to make significant progress in leveraging real-world evidence to help get safe and effective drugs to market faster and more cost-efficiently.”

Using data from the actual experience of patients during real-world situations — in addition to traditional data obtained from randomized controlled trials — will advance drug safety and effectiveness in a wider population, the report notes. Real-world data are available through electronic medical records, claims databases, laboratory and pharmacy systems, registries, and patient health-monitoring devices.

The report recommends that FDA develop formal guidance on the use of real-world evidence to help its regulatory decision-making, including the circumstances where such data could be used, the types of real-world data, methods, and the levels of evidence that would be acceptable for use in regulatory review and decision-making. It also says the agency should establish a program to promote sharing and methods evaluation for real-world evidence for regulatory decision-making. “The FDA should invite a broad spectrum of researchers who are active in the generation and use of real-world evidence and methods development, as well as leaders who rely upon such real-world evidence — including regulators and payers — to participate in this program,” it says.

In addition, the report recommends that FDA develop a new program to develop and test a new adaptive pathway approach to expand the capacity for drug development under a real world evidence scenario. Such a program should have the following key attributes: 

- Iterative phases of development, beginning with initial marketing authorization to a restricted patient population, then expanding to wider populations based on risk-benefit ratios;
- Gathering evidence through close-monitoring and other real-world evidence, to supplement randomized trials; and
- Early stakeholder involvement for those who have a role in determining patient access to a drug, including industry, payers, regulators, clinicians, and patients.