Anyone who has worked in a clinical setting knows that wounds, from burns to ulcers to injuries, are painful, disrupt lives, and often are difficult to treat (needless to say, carry a significant cost burden to our health spend). To find the treatments that will make a difference, small to large medical device manufacturers and pharmaceutical companies spend millions of dollars on research and development yearly.
It’s not always easy. Research into wound care can be problematic, with issues ranging from difficulties in patient recruitment and engagement to multiple complications encountered during the trial period.
Times are changing. We’re beginning to find ways to meet those challenges. Some of the more promising trends on the horizon are the use of digital technology and the adoption of virtual, decentralized clinical trials.
Benefits of Virtual Clinical Trials
There are many benefits to virtual trials incorporating digital tools. They include:
- Ensuring important research continues as patients don’t need to travel as frequently to an offsite facility to be assessed or receive their treatment.
- Creating efficiencies and managing costs by significantly reducing the need for cumbersome and repetitive paperwork such as filling out forms, scanning and faxing reports and charts, etc.
- Enabling providers and trial administrators to see images of wounds in real-time and provide rapid feedback. This provides greater control and monitoring of the wound and ensures better efficiencies and more optimal care.
- Reducing participation drop-outs and keeping patients more engaged, empowered and involved through education, reminders and ongoing contact with clinicians.
- Facilitating the participation of a more diverse population that better reflect the current state of affairs in the market.
On-Demand Webinar: Virtual Clinical Trials: How Digital Tools Facilitate Wound Care Research During COVID-19
A Better Way
While the benefits of virtual trials are clear to see, setting one up isn’t simply a matter of a smartphone camera and internet connection. Traditional wound care research is a time-consuming process, taking up to two years or more. Often, after the time and effort spent on the initial trial startup, patients will drop out, requiring the recruitment process to begin anew.
There’s a better way. It begins by ensuring the right providers and participants are targeted from day one. Historically, one of the most relevant populations for wound care research – patients in long-term care (LTC) and skilled nursing facilities (SNF) – are overlooked. However, advancements in telehealth are showing researchers that this population can and should be targeted for wound healing research.
Whether on a laptop, tablet, or smartphone, specialized wound care apps enable providers to take an image of a wound, send it to the trial administrator, and get real-time feedback on whether or not the patient meets study criteria through a streamlined screening process
Targeting the Right Doctors and Patients
Over the past few years, Tissue Analytics has conducted studies with this population, leading to important insights as to its benefits and the steps to take to ensure an effective clinical trial. LTCs and SNFs often welcome the opportunity to participate in clinical trials. They typically operate on thin margins. Their leadership and providers welcome programs that will enable them to provide better care to patients and generate an important new revenue stream for their organizations.
Additionally, targeting an outpatient population also helps ensure the most qualified providers are part of the clinical trial. Physicians and nurses working at outpatient wound care centers understand wound care. They can readily identify potential patients. Data from specialized electronic medical records (EMRs), such as Net Health® Wound Care (formerly WoundExpert®), further enable rapid identification of providers and patients and aid in data gathering and dissemination. This can present a significant advantage in identifying the right facilities which are currently addressing the desired populations for an effective and successful recruitment and trial timeline.
Once the location and providers are finalized, it’s time to recruit participants. Here’s where digital technology comes into play. Whether on a laptop, tablet, or smartphone, specialized wound care apps enable providers to take an image of a wound, send it to the trial administrator, and get real-time feedback on whether or not the patient meets study criteria through a streamlined screening process. If so, the digital tool can also be used to obtain and document consent electronically to swiftly onboard the patient into the trial.
If the trial participant is in an LTC or SNF, nurses and caregivers can take weekly images to record progress remotely from the bedside. In home care settings, the patient, caregiver, or family member can take the image with a simple app on their cell phone, all while maintaining compliance with HIPAA, GDPR and CFR Part 11.
Embracing the New
The use of virtual clinical trials and digital tools marks the beginning of a new era. One with the promise of faster outcomes, a more efficient trial process, and the ability to better target providers and patients. The potential of virtual trials has not been lost on the FDA. They are now actively supporting efforts to increase the use of virtual clinical trials, especially those that show real-world data.
The next few years and beyond will bring exciting innovations from virtual trials and digital technologies. However, their true value is in the ability to bring the products to the marketplace that will improve the quality of life for millions of patients and even save lives.
Tissue Analytics is one of the pioneers in the use of digital technologies and virtual clinical trials. To find out more, email ClinicalResearch@TissueAnalytics.com or call (800) 411-6281.
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