Each year, nearly 85 million Americans see a physician for at least one skin disease, with $75 billion in direct costs to the U.S. healthcare system.[i] While the FDA has approved more than 110 dermatology drugs, these treatments address only about 30 indications, leaving the vast majority of known skin conditions unaddressed. In recent years, there has been a significant increase in dermatology drug development to help address this need for safe, effective treatments for a broader swath of skin diseases. This trend—in conjunction with the push for more patient-focused studies and the pressures posed by the pandemic—has led to wider adoption of decentralized clinical trial approaches in dermatology.
Decentralized clinical trials (DCTs) are patient-focused, technology-enhanced studies that leverage approaches such as telemedicine, wearable medical devices, home visits, and direct delivery of study drugs to patients. DCTs can be applied in all stages of the dermatology and medical aesthetics drug or device development process. A key benefit of decentralizing clinical trials is making studies more acceptable and more accessible to a wider, more diverse array of eligible participants.
DCT approaches help maximize patient enrollment and retention by reducing patient burden, potentially saving time and money. However, compared to traditional studies, DCTs present unique challenges that affect protocol design.
In this blog post, we explore the top seven challenges in decentralized dermatology trials and how to address them.
1. Making the trial accessible for patients who do not have reliable internet access or technological know-how
While DCTs help eliminate geographic or locational obstacles to clinical trial participation, lack of stable connectivity or familiarity with technology can still be limiting factors, especially for fully virtual studies. Hybrid trials that combine in-person visits with decentralized applications may be helpful. Sponsors may also consider giving patients the option for data collection methods that require less technical savvy.
2. Keeping investigators and sites involved in patient care
As DCTs become more popular, sponsors and CROs may be wondering about the impact of decentralization on the roles and responsibilities of investigators and sites. As trial operations become more dispersed, investigator oversight and site engagement become even more critical for ensuring human subject protection and high-quality data. In-person site visits may be important for study participants who require guidance or support depending on the protocol. Investigator and site involvement is also essential for maintaining patient adherence or proper use of the investigational products or digital devices used for data collection.
3. Finding the right technology
Dermatology DCTs require technology that either provide live interaction or can quickly and securely transfer and store data from wearable technologies and remote locations. Finding fit-for-purpose solutions that meet all clinical strategy, operational, and regulatory criteria can be difficult and, even when they are available, the cost may be prohibitive. Therefore, evaluating the pros and cons and understanding the expected return on investment for any technology is critical.
4. Implementing new technology
Training will be required for all clinical research staff when implementing a new technology, which may be difficult to coordinate. Training will also be required for study participants, as they will need to be proficient in using that technology to follow the protocol successfully. Having personnel assigned to the study who can support both the site and the patient with technology and data expectations is critical to success.
5. Ensuring accuracy, reliability, and reproducibility
Accurate, reliable, and reproducible assessments are essential for high-quality data sets. Therefore, in dermatology DCTs, it is vital to plan ahead and clearly outline the protocol processes for standardizing data collection, including photography and high-resolution video communication.
6. Minimizing the likelihood of protocol deviations
DCTs tend to have a higher risk of protocol deviations than traditional clinical trials since study participants are recording and sending data from their own locations. In hybrid models, sites can provide training to study participants and collect certain data to ensure protocol adherence. Ensuring that a risk-based remote data monitoring capability is a standard study process is essential to pinpointing potential challenges and addressing them early in the process.
7. Controlling environmental factors
If study participants are not going to sites, they are collecting assessments in different environments and under different circumstances, affecting data quality. Consequently, the protocol needs to include language that standardizes the process of data collection and reporting
Addressing these seven challenges helps ensure that a dermatology DCT protocol is not only built with the patient in mind, but also designed to generate high-quality data.
Are you ready to decentralize your next dermatology trial? Download our Expert Guide to Decentralized Dermatology Trials: 5 Strategies for Study Success.
[i] Lim HW, et al. The burden of skin disease in the United States. J Am Acad Dermatol. 2017;76(5):958-972.