One of the many things interrupted by COVID-19 has been Clinical Trials.1 And that is deeply impacting the healthcare system, from researchers to physicians to patients. Clinical research is vital to finding new ways to treat illness and disease and to ensure that patients have access to the best possible treatments for their conditions.
Recently, Net Health hosted a webinar with Thomas E. Serena, MD, founder and medical director of the Serena Group, and Nico O’Kuinghttons, vice president of Business Development for Clinical Trials for Tissue Analytics, a Net Health company, to explore this very topic. More specifically, how the current pandemic affects critical wound care research and how digital tools can be used to ensure this research continues.
Introducing Virtual Clinical Trials
The Serena Group is a global healthcare company with expertise in wound care research. Combined with Tissue Analytics’ mobile wound and skin imaging and predictive analytics solutions, the two companies are at the forefront of the emerging virtual clinical trials marketplace.
A virtual trial, or decentralized clinical trial, is defined as a clinical research study, in which one or all of the trial participants’ visits do not occur in a traditional office setting, such as a clinic or hospital. Most virtual trials incorporate remote monitoring technology and are performed in the home via telehealth, with some conducted in hospitals, clinics, or nursing facilities.
Goals and Benefits of Virtual Trials
The goal of virtual trials is to remove barriers and provide greater access to potential trial participants. They offer a number of other benefits as well, including:
- Greater convenience for research participants as they don’t have to travel to the wound clinic for a clinician to monitor their status and gather research data. Participants can remain in the comfort of their residence.
- Faster and increased study enrollment (because participation is so much more convenient).
- Better retention of subjects, as the ease of participation means fewer people drop out because of challenges getting to the clinic for check-ins, etc.
Yet another benefit of virtual trials is its ability to ensure greater diversity in the populations participating. Historically, racial and ethnic minorities in the United States are significantly under-represented in research.2 This leads to the disenfranchisement of many populations who not only could benefit from participation in clinical trials, but whose data is vital to a robust research program.
Recognizing this need, the FDA has become very involved in stressing the need to ensure participant diversity. Virtual trials can significantly increase that participation for the reasons noted above.
The Role of Digital Tools
For success in the COVID-era, a research trial needs to incorporate the right tools. Specialty software applications can help monitor participants remotely, communicate information to and from the study participant, and provide education and encouragement. Digital tools offer a wide range of benefits for virtual trials; one of the most important is recruitment. Digital trial recruitment ensures:
- There are no geographical limitations for the study
- A more diverse patient group
- Access to additional care settings, such as patients in home care or Skilled Nursing Facilities (SNFs)
Digital solutions also expand participation opportunities by making it easier for caregivers and nursing staff to assist with the recruitment of patients. For example, with proper consent, a nurse at a skilled nursing facility can enroll patients that may be good candidates for a research study.
Enrolling in a virtual wound care clinical trial can be simple. Patients (or caregivers) can submit wound images and information through a mobile application for pre-screening to aid in the recruitment process. Images will show the size of a patient’s wound, location, and other relevant information needed to appropriately screen trial candidates.
Components of Effective Programs
While there are many advantages to virtual clinical trials in wound care, it is important to have the right tools, resources and support. Those considering development of a virtual clinical trial should ensure their supporting software offers the following:
- Mobile wound imaging and analysis
- Cloud-based portal for participants and study authors
- Adherence to study timelines
- Real-time communications
- Digital tools that are simple for study participants to use
There are other considerations as well. For example, an essential component of effective clinical research is the ability to include alerts and reminders, effectively remind participants when it’s time to change dressings, apply a therapy, turn on a device, etc.
Additionally, the FDA stresses the importance of Patient Reported Outcomes (PRO). With advances in wound care, researchers will want to pay special attention to gathering PRO insights. Once again, virtual clinical trials, when combined with digital tools can help make that happen.
The Future of Virtual Clinical Trials in Wound Care
With the ripples from COVID-19 set to continue for the immediate future, the need to develop and expand virtual clinical trials will continue. Through its technology, Tissue Analytics and its partners have the experience and tools needed to help organizations develop, recruit, implement, monitor and report on the full range of data necessary to conduct an effective research program.
1New York Times, “Clinical Trials of Coronavirus Drugs are Taking Longer than Expected,” Aug. 14, 2020
2U.S. Food & Drug Administration, Minorities in Clinical Trials Fact Sheet, May 23, 2019