In a fast-paced digital world, healthcare has had to adapt to better serve consumers who increasingly prefer or rely on web- or app-based services. Telehealth (or e-health) solutions are providing increased access to care, making it easier not only for patients to receive care, but also for healthcare professionals to deliver that care. For healthcare professionals who treat dermatological conditions, visual assessments are a critical component of evaluation and diagnosis. Advancements in medical technology that enable the capture and transmission of high-definition digital images have opened the door for dermatology e-health programs, and these same technologies have the potential to radically change dermatology trial designs.
Lowering the Cost of Care and Improving Outcomes
Digital disruption in the dermatology field is happening on a number of fronts. In addition to improved image capabilities, new tools are helping patients build knowledge about their healthcare conditions and understand their medical histories. Online interactions are empowering and inspiring patients to take control of — and responsibility for — their health through increased and ongoing self-management.
The benefits of dermatology telehealth options extend to both patients and providers and include:
- Reduced wait times: Digital health assessments make time spent scheduling, traveling and waiting a thing of the past. In many cases, response times may be as short as 24 hours. In addition, e-health tools allow patients to follow up in real time from the convenience of their home.
- Improved access: For example, dermoscopy, a non-invasive diagnostic modality, allows the detailed evaluation of colors and microstructures of the skin down to the papillary dermis. Dermoscopy assessment is more accurate than evaluation by the naked eye, especially in skin cancer screening. With teledermoscopy, dermoscope images can be taken by a general practitioner transmitted to a dermatologist electronically for evaluation and diagnosis.
Moreover, telehealth helps address an unmet medical need by bringing dermatology care to remote or underserved locations.
- Lowered costs: Dermatologists embracing the digital format incur lower costs, such as physical office expenses, and these savings can be passed on to patients. Telehealth can also reduce the number of unnecessary referrals and the costs of providing and receiving dermatological care — for example, for skin cancer screening or monitoring of skin ulcers and chronic skin diseases.
- Same or higher level of care with improved patient satisfaction and outcomes: In early 2018, a study presented at the American Academy of Dermatologists showed that patients receive at least the same level of care from telehealth as from in-office examinations. Conducted at the University of Southern California’s Keck School of Medicine, the 12-month study compared the results of two groups of 150 psoriasis patients and found that telehealth patients enjoyed better outcomes than their in-office counterparts. Lead researcher April Armstrong, M.D., told MedPage Today, “We know that a lack of regular access to dermatology providers results in poor health outcomes. And when we think about the future, we know that after 2020, there will be more people over the age of 65 than under the age of 5, which means the population is continuously growing, and there is a continuous need for dermatology and dermatology providers.”
Enabling Virtual Clinical Trials
Beyond the clinic, e-health technologies are poised to transform dermatology clinical trials. Participating in a clinical trial can be a burden — from travel time and wait time to lost productivity at work or school, study participation often represents a significant commitment. Technology can help sponsors overcome many of the barriers patients face when deciding whether to participate in a clinical trial. With advances in technology, an increasing amount of valuable data can be captured from the comfort of a patient’s home, opening the door to a broader, more diverse population of clinical trial participants.
Virtual clinical trials — also known as site-less clinical trials — are still a relatively new method of collecting safety and efficacy data from clinical trial participants. However, with the drive to lower R&D costs while also improving the patient experience, the number of virtual clinical trials is on the rise. Advantages of virtual clinical trials include:
- Ability to capture data points without requiring the patient to travel to the clinic
- Improved accuracy in detecting adverse events or the first signs of efficacy as they occur in real time
- Remote eligibility screening
- Accelerated enrollment
- Ability to gather data from a real-life setting and other patient-driven data
- Improved retention
Through a combination of advanced technologies — apps, wearable sensors, and other monitoring devices — sponsors can design studies and social engagement platforms that enable them to conduct nearly every stage of a clinical trial remotely, including recruitment, informed consent, education and counseling, and measurement of clinical endpoints and adverse reactions.
Overcoming Barriers to Adoption
Despite the benefits, there are barriers to widespread adoption of dermatology e-health technologies in office settings and clinical trials, particularly in the area of patient perception. Among the concerns that cause some patients to shy away from digital platforms, those related to information privacy and security, and prescription-filling are most prominent.
However, many of these issues can be addressed through continuing education and awareness around these new technologies. Electronic files are already commonplace in healthcare, and the security of digital dermatology platforms is consistent with industrywide record-keeping protocols. Referrals for biopsies can be made through digital platforms, and the shortened dermatologist response times can improve early intervention. Finally, paper prescriptions have largely been replaced by digital ones, and telehealth resources can digitally send prescriptions to local pharmacies.
From a regulatory perspective, the FDA recently issued a number of guidances and draft guidances relevant to digital health:
- Software as a Medical Device (SAMD): Clinical Evaluation — Guidance for Industry and Food and Drug Administration Staff
- Clinical and Patient Decision Support Software — Draft Guidance for Industry and Food and Drug Administration Staff
- Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act — Draft Guidance for Industry and Food and Drug Administration Staff
The FDA also launched a precertification pilot program to help the agency determine the key metrics and performance indicators for assessing the safety and effectiveness of digital health software technologies. Outside of the U.S., regulations for the use of teledermatology in clinical trials vary, and the guidelines vary in maturity from country to country. For example:
- In late 2017, JASEHN — the European Union’s Joint Action to Support the eHealth Network — released an extensive report on the state of telemedicine services and recommended establishment of an EU telemedicine strategy. It also urged EU member states to consider creating a structure to foster adoption of telemedicine and telecare on a national scale
- Within the European Union, the U.K. is the largest spender on telehealth and actively promotes the use and expansion of digital health services
- Telemedicine trials have been conducted for more than a decade worldwide. To date, more than 25 telemedicine studies specific to skin diseases and performed in North America, Europe, Asia, Australia, and Latin America have been registered at clinicaltrials.gov
- In the Netherlands, teledermatology is fully reimbursed and integrated into the country’s healthcare infrastructure
- In Australia, telemedicine practice has been covered by specific guidelines and legislation for more than five years
- In France, the Social Security Financing law introduced the reimbursement of teleconsultations effective September 15, 2018
At Premier Research, we are committed to making your trial a success by utilizing the latest technologies and strategies in trial design. For more information on planning your next dermatology trial, contact us today.
 U.S. Food and Drug Administration. Digital Health Software Precertification (Pre-Cert) Program. Available at https://www.fda.gov/medicaldevices/digitalhealth/digitalhealthprecertprogram/default.htm.