AROA Biosurgery uses Net Health’s RWD to demonstrate product superiority
Over the last few years, excitement has been building about the benefits of using real-world evidence (RWE), obtained from real-world data (RWD), to demonstrate the efficacy and safety of drugs and devices. Pharmaceutical companies, device manufacturers and, most importantly, the Food and Drug Administration (FDA) are enthusiastic about the benefits of research based on RWD.
“The use of computers, mobile devices, wearables and other biosensors to gather and store huge amounts of health-related data has been rapidly accelerating,” explains FDA. “This data holds potential to allow us to better design and conduct clinical trials and studies in the health care setting to answer questions previously thought infeasible. In addition, with the development of sophisticated, new analytical capabilities, we are better able to analyze these data and apply the results of our analyses to medical product development and approval.” (1)
RCTs versus RWD studies
In the past, scientific studies were not considered credible unless they were RCTs. In a randomized controlled trial, study subjects are placed by chance into either a group that receives a particular intervention or a control group. The “control” can be the use of a standard practice, a placebo or no intervention. The results from this group are compared to the treated group to determine if positive results occur.
While RCTs reduce bias and give researchers a rigorous tool to examine cause-effect relationships between an intervention and outcome, they also present researchers with ethical and applicability issues. Furthermore, RCTs are costly, time-consuming and can be logistically complicated.
In contrast to prospectively managed and highly selective RCTs, RWD studies mine massive datasets from electronic health records (EHRs) and other sources for information about how products have been used and the results. These broad, retrospective studies reflect actual clinical situations, and they can be done for a fraction of the time and cost.
The research partnership between Net Health Data Solutions and AROA Biosurgery is a case in point. Using Net Health’s RWD, AROA researchers designed a study that showed its EndoformTM Natural soft-tissue regeneration product out-performed a frequently used collagen/ORC dressing when used in the management of diabetic foot ulcers.
AROA Case Study: The Power of RWD
AROA knew an RCT would be lengthy and expensive, and the results may not reflect the patient population treated by wound care providers, its target market. What it needed was access to a repository with data on EndoformTM Natural’s use in a wide range of clinical situations. So, it turned to Net Health Data Solutions.
What Net Health provided was a comprehensive, standardized, all-in-one database, coupled with expert consultative services to ensure that the data samples were compiled and interpreted properly. With this data and guidance, AROA was able to publish a study that showed wounds treated with Endoform Natural healed significantly faster than those treated with a collagen/ORC dressing.
The AROA study illustrates the value RWD studies hold for manufacturers, researchers and clinicians. While they won’t replace RCTs, RWD studies will be an increasingly important and influential tool because they deliver faster and more economical results, that better reflect patients treated in typical clinical situations.
Read the complete story of the Net Health-AROA research partnership and Endoform here.