Expert Guide To Decentralized Dermatology Trials: Five Strategies For Study Success

To optimize the likelihood of success, dermatology clinical trials should be designed with the patient in mind, minimizing the burden of participation and maximizing accessibility for a diverse population of qualified patients. In a development space as active as dermatology, where competition for eligible participants is intense, adopting a patient-focused approach is essential for meeting enrollment targets and timelines and ensuring high-quality data collection. This patient-focused approach is the core of the decentralized clinical trial (DCT) philosophy, and sponsors are increasingly turning to DCT approaches to accelerate their development programs.

In the broadest sense, a DCT is any trial involving data collection at an offsite location rather than a clinical site. DCTs leverage virtual tools to enable remote completion of trial tasks that normally involve in-person interactions. Decentralized approaches range from home visits and home delivery of study drugs and materials to the use of digital technologies for consenting patients, training study staff, monitoring health status, and collecting endpoint data. These approaches can be applied during any phase of clinical development and are commonly used in combination with traditional site visits to create hybrid trials.

DCTs offer a plethora of potential advantages –expansion of the available patient population and reduction in patient and investigator site burden –but also pose challenges, including:

• Determining which digital clinical trial practices will be acceptable from a clinical and regulatory perspective
• Ensuring remote assessments can be performed safely, accurately, and consistently
• Selecting the right technology or platform
• Bridging clinical operations and technology to ensure seamless study execution
• Managing the flow of data

This expert guide offers five strategies for addressing these challenges and optimizing study success.