The COVID-19 pandemic and the logistical roadblocks it created for clinical trials have raised the profile of virtual trial solutions for many pharmaceutical companies. Now, more than ever, trial sponsors are realizing it is critical to consider decentralized solutions, such as virtual trials and other remote capabilities, to ensure drug development continues through the volatility of the pandemic and beyond. While virtual trial platforms have been used sparingly over the past several years, the pandemic escalated the need for virtual elements. Sponsors have experienced first-hand how different components of virtual trials can be beneficial for future programs in both a COVID-19 environment and where COVID-19 is no longer prominent.    

Sponsors must determine to what extent they can incorporate virtual solutions into their programs. One key factor to consider is the therapeutic area, as each area has innate risks and benefits. Like many other therapeutic areas, during this pandemic enrollment in dermatology trials has been impacted. The good news is that dermatology trials can be a nice fit for decentralized solutions, creating positive outcomes for sponsors and keeping trials on track for patients. Dermatology trial endpoints are primarily ascertained on visual assessments thus providing an opportunity to evaluate skin conditions without physically being on-site. This type of assessment can be achieved utilizing virtual options such as remote photography.

While it is not practical to think every dermatology trial can be 100% virtual, it is possible to customize and incorporate virtual aspects into these programs with a hybrid approach. This approach can enhance the patient experience and help sponsors achieve their goals in a timely, cost-efficient manner with no increase in risk to quality. 

Increasing Opportunities

Utilizing virtual trial elements offer sponsors several unique benefits that on-site traditional models are not able to achieve. Leveraging large amounts of global patient data and analytics to identify and recruit patients, sponsors have the ability to select the right patient for their trial no matter their proximity to a site. This eliminates the logistical challenges of travel or reaching those in more rural areas, while also relieving patient burden during study participation. Because many patients in dermatology trials are generally in good health and are actively working, reducing their time on-site increases the likelihood of participation and can help with retention. By allowing patients to participate from wherever they may be through user-friendly, tech-enabled platforms, they can stay engaged and provide required feedback without visiting a site. For study teams, this means securing more real-time patient-reported outcomes. Study teams can easily monitor this electronic data for early signal detection of adverse events and quickly implement remediation activities. This is a critical tool for patient safety management and a top priority for sponsors.

Tangible steps to going virtual in dermatology

As we know, each study is unique. Matching the appropriate virtual trial solution to the study design is an essential first step. Risk assessment tools are valuable in determining potential medical and patient safety risks. Depending on the treatment, subject population, endpoint needs, and study design, sponsors can identify exactly where virtual solutions can be incorporated in dermatology trials. Advancements in digital tools and photography create an opportunity for assessments of skin conditions from a remote setting. In some cases where more complex assessments or treatments are required, such as skin biopsies, a hybrid approach that encompasses both virtual elements and on-site visits would be an option. To conduct other assessments that are traditionally completed on-site, it may be possible to incorporate home health nurses or phlebotomists to conduct safety evaluations or collect lab sampling at a participant’s home.

Across the industry there is an increased understanding of the value of patients as partners in clinical development. The foundation of virtual trial solutions rests heavily on how to reduce the burden on patients to ensure they have every opportunity to actively participate in trials that ultimately can impact their healthcare. One way to achieve this is to provide patient support throughout the entire trial process by utilizing virtual study team members dedicated to helping the patient manage their study activities. Virtual study coordinators can assist sites by focusing on enrollment processes, thus allowing the site to focus on patient care. A study concierge can help guide patients through the nuances of a trial, especially regarding logistics and device training. These virtual team members assist patients with scheduling telemedicine visits, laboratory visits, and home healthcare nurses. As new molecules are introduced in dermatology, we are seeing an increase in the complexity of study designs including procedures that require cross-therapeutic coordination for MRIs, ophthalmology, pulmonary function testing, and extensive cardiac monitoring. The concierge role can help coordinate these activities as well. 

The disruptive effects of COVID-19 have certainly given sponsors a specific reason to consider adopting virtual options for their trials. With appropriate planning and strategic consideration of these virtual options early in the process of protocol design, we know these solutions may allow for faster, higher quality, patient-centric studies well beyond the pandemic. As the landscape of clinical development changes rapidly, we know dermatology is a therapeutic space that lends itself to use of tech-enabled virtual tools that can help reduce patient (and site) burden while maintaining the critical elements of patient safety and data integrity for sponsors.

Please contact me to discuss how we can help incorporate virtual approaches into your dermatology trial.