RWD vs. RWE

REAL-WORLD DATA VS. REAL-WORLD EVIDENCE

In 2016, the Food and Drug Administration (FDA) passed the 21st Century Cures Act in effort to incorporate more patient perspectives and expand the approved types of data that can be used to support regulatory drug development decisions. The Cures Act is a step towards improving the FDA’s capability to streamline clinical trial designs and clinical outcome assessments, which includes the use of real-world data and evidence.

The FDA defines real-world data* (RWD) as “the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” This can include data from the following sources:

  • Electronic health records
  • Insurance billing and claims
  • Product and disease registries
  • Patient-generated data (e.g. patient-reported outcome measures or surveys)
  • Biometric monitoring devices (e.g. mobile phones or watches)

The Cures Act additionally provides guidance on the use of real-world evidence* (RWE), which states it is “the clinical evidence regarding the usage and potential benefits/risks of a medical product derived from the analysis of RWD.” RWE is essentially the analytical data which details the use, potential benefits, or risks of a drug obtained from non-traditional clinical trials such as:

  • Randomized controlled trials, or RCTs (including large simple trials and pragmatic trials)
  • Observational studies (prospective and/or retrospective)

With the use of RWE, the FDA has better understandings on how to best design and operate clinical trials/studies in healthcare settings to resolve unanswered questions and improve treatments. 

TARGET has redefined what’s possible in generating and analyzing real-world data and evidence.

Contact us to learn more about TARGET’s solution and how we can fulfill your RWE needs!

HOW IS TARGET RELATED TO RWD AND RWE?

TARGET is an innovative healthcare data company that generates regulatory grade, real-world clinical data and evidence.  We are redefining the access and utilization of RWD/RWE solutions by creating fit for purpose data to suit any needs.

Our company was built on a core platform solution that includes an in-depth real-world database of 5+ years of collected patient data, encompassing a multitude of diseases, that healthcare industry partners can query at any time for in depth analyses through a full-service subscription. TARGET also provides custom project support to help answer any questions you may have that requires high quality data sets, regardless of therapeutic area.

Healthcare industry partners can utilize the TARGET platform to fulfill post-marketing commitments, pediatric data requirements, evaluate underrepresented populations, and more. TARGET’s data management and analyses are hosted in-house, which means partners eliminate the operational hassle and long-term costs of developing or maintaining a disease registry and accessing claims databases.

Further, TARGET actively seeks and discusses publication topics with each disease-specific steering committees, including partners, to publish relevant disease findings based on data obtained from TARGET cohort registries.

TARGET’s real-world database has been used to support protocol designs, site selection, inclusion/exclusion criteria, the natural history of disease progression, and identification of disease biomarkers. With an extensive database and proven track record, TARGET has additionally built custom RWD/RWE solutions based specifically for our partner’s needs and/or timely projects.

 

*Source: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence

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