Real-World Data (RWD) is having a moment. Clinical trial sponsors, investigators, regulators, and payers are embracing this powerful addition to clinical research, which offers critical insight into how patients use products in the real world.
What is RWD?
Randomized controlled trials (RCTs) remain the gold standard for evaluating the safety and efficacy of an investigational therapy. Still, the evidence derived from them does not always represent real-world settings. Studies utilizing RWD, however, can result in meaningful perspectives by minimizing the bias from narrowly defined patient populations, a foundational characteristic of RCTs.
An array of guidance from the Food and Drug Administration (FDA) describe how RWD can be used to help the agency make regulatory decisions about drug and biological products. One Draft Guidance from 2021 defined RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” These sources may include:
- Medical claims data
- Product and disease registries
- Patient-generated data, including from in home-use settings
- Data gathered from other sources that can inform on health status, such as digital health technologies
For wound care, the impact of RWD is enhanced through greater use of mobile platforms with state-of-the-art machine learning and computer vision algorithms that facilitate accurate measurement of wounds, a crucial part of wound care. The digital option dramatically improves the traditional wound measurement method of using a ruler. Data from Tissue Analytics, a Net Health company, indicate that measurement errors with its automated platform are less than 4%, as compared to 44% with rulers.1 Moreover, the data can be automatically uploaded into an electronic health record (EHR), which can become part of a vast RWD database that can be mined for retrospective clinical studies.
A Real-World Example of RWD Data: A Retrospective Case Study
An article in the August 2021 issue of International Wound Journal describes a retrospective wound care study on diabetic foot ulcer (DFU) conducted by AROA Biosurgery with its unique product, Endoform Natural™, which uses decellularized extracellular matrix technology. The company opted for this study design to harness the power of RWD to evaluate whether Endoform Natural was superior to existing collagen/oxidized regenerated cellulose (ORC) dressings for DFUs. The RWD came from the proprietary Net Health® Wound Care database representing 449 wound care centers across the United States.
The critical decision to conduct an RWD retrospective study was based on the fact that a traditional RCT would have been costly and time-consuming, while still not reflecting the patient population treated by wound care providers. Research suggests that the severity of DFUs included in RCTs is generally not representative of typical clinical practice, with 43.6% of real-world DFUs rated as severe ulcers. In contrast, many RCTs only included less severe cases.2 Also, given the exclusion criteria typical of RCTs, it is estimated that they accurately represent a mere 4% of the real-world wound population.
The Finding Today’s Researchers Need
AROA’s study demonstrated that wounds treated with Endoform Natural healed significantly faster. Time to wound closure was between 1.9 to 5.6 weeks faster in the Endoform Natural group, a reduction of 11.3% to 21.4% relative to the collagen/ORC group. The probability of wound closure also increased by between 18% to 38%.3
Findings like this are meaningful to the health care community for many reasons, including to support coverage decisions, and to develop guidelines and decision support tools for use in clinical practice.
Most importantly, data gleaned from RWD sources like EHR data provide real insights into how products will be used – and how they can best benefit – today’s patients.
Find new ways to improve your RWD
For more information on how Net Health Data Solutions can help to provide better RWD, visit our website here.
To download the AROA case study, see here
1Automated Wound Measurement Saves Time, Tissue Analytics, Lancaster General Health Innovation Center, case study. Additional information at www.tissue-analytics.com
2Fife C., Eckert K., Carter M. Publicly Reported Wound Healing Rates: The Fantasy and the Reality. Advances in Wound Care. March 2018.
3Bosque B., Frampton C., Chaffin A., et al. Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers. International Wound Journal. August 2021.