Experts with Tissue Analytics Clinical Research, a Net Health company, outlined today the trends in wound care clinical trials on the horizon for 2022. With one of the world’s largest wound care databases, a flexible electronic health record (EHR) platform used in most wound care settings, and extensive clinical trial expertise, the company is uniquely positioned to provide insight and analysis on the topic. The top trends include:
- Thorough analysis of the impact of COVID and emerging variants on wound care. Data shows that wound care visits were down for the first eight months of COVID but began to increase by the summer of 2020 and are now on track to exceed pre-pandemic levels. It’s believed that telehealth, mobile apps and innovations have helped but not thoroughly addressed reductions in wound care visits during COVID. Much more research is needed to identify areas of need and opportunity. Using its extensive database, Net Health is collaborating with its partners to identify factors influencing utilization.
- More guidance and involvement from the Food & Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS) in wound care research. Industry insiders note that increasing guidance from the FDA is overdue as the last set of standards for wound care product development was set in 2006. Over the past few years, the FDA has started to ramp up its focus on wound care. Areas of highest interest for regulators include how to better measure success in healing and how to better support patients and caregivers.
- Greater discussion around non-healing, chronic wounds. FDA guidance on the treatment of chronic wounds is needed. There is a growing recognition of the difficulties in healing chronic wounds, especially within elderly and under-served populations. The FDA can provide some much-needed insights and guidance about what they would like to see in terms of product development, focus, outcomes and more.
- More emphasis on patient and caregiver experience and needs. There is currently a disappointing lack of insights into the patients’ journey and experience with chronic wounds. Issues such as social determinants of health (SDOH), barriers to accessing technology, lack of wound education and more must be addressed to ensure patients receive optimal benefits from therapies and that all involved in the process have the information required to support care.
- Expansion of the wound care research pipeline and processes. For years, would care research has lagged far behind other diseases and conditions. However, a growing emphasis on value-based care and the desire for providers to prevent “never” events and related penalties for hospital-acquired pressure injuries (HAPIs) is spurring research into such conditions. Several leading manufacturers are ramping up research for new products signaling significant investment in this area.
- Greater emphasis on recruiting and retaining qualified trial participants. A number of publications have reported that the pandemic significantly curtained many clinical trials. Social distancing closed an estimated out of 10 study sites1, and researchers scrambled to find alternatives. The Journal Nature reported that enrollment “plummeted” at the height of the pandemic. However, decentralized trials supported by mobile digital imaging – such as those provided by Tissue Analytics – have fueled a number of new clinical trials over the past year. Early data indicates that today’s wound care trials could show significantly higher recruitment and retention levels.
- Emphasis on patient registries and real-world evidence. The expansion of mobile technologies and the need for more trials will spur more companies to develop their patient registries. By building their own list of patients to participate in trials, manufacturers can more efficiently advance research showing the efficacy of new products and collect real-world data.
- Focus on making it easier for physicians to participate in trials and report data. While manufacturers want to support programs that facilitate the collection of real-world evidence, a crucial challenge is securing the time and support of busy physicians to participate in trials. Based on its existing widely used hospital wound care platform. The Tissue Analytics Clinical Research offers an integrated solution focused on the needs of researchers, physicians and participants to make it easier to participate in trials. Physicians simply take pictures of participants’ wounds and upload them directly to the platform using the company’s easy-to-use mobile apps. Data analysis would take place on the backend, removing the time and administrative burden most clinical trials place on physicians today.
Start the New Year off on the right foot . . .
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Why New Approaches to Wound Care Clinical Trials Are Here to Stay
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1“COVID-19 and clinical trials: The Medidata perspective,” Medidata Solutions, May 2020, medidata.com