The FDA has underscored the significance of identifying and assessing therapy-induced changes meaningful to patients in regulatory decision-making for clinical trials. Chronic itch, affecting 8-25% of individuals during their lifetime, significantly diminishes the quality of life due to its disruptive impact on sleep, causing embarrassment, social isolation, and depression. This condition, prevalent in autoimmune disorders and chronic skin conditions like atopic dermatitis and plaque psoriasis, presents an unmet need for quantifying scratching in patients' natural environments.
Regulatory agencies are increasingly embracing digital health technologies (DHTs) in drug development, as wearables offer a unique avenue to continuously measure novel endpoints. Nocturnal scratch, an advanced application of DHTs, provides a valuable real-world patient-centric outcome, aligning with the shift toward objective measures in clinical trials. Over 70% of patients express the value of measuring nocturnal scratch, highlighting its importance in assessing interventions' effectiveness and overcoming limitations of patient-reported outcomes, particularly in pediatric populations.
DHT-derived endpoints, such as nocturnal scratch from wrist actigraphy, offer rich patient-centered data, capturing real-world experiences, and mitigating recall bias. Actigraphy, measuring wrist motion, provides a low-burden means of estimating scratching and assessing symptoms' impact on sleep, surpassing the impracticality of other objective measures like vibration sensors and transducers.
Dive into recommendations released by the FDA regarding the use of DHTs in clinical development and the opportunities wearable-based digital endpoints present to the life sciences industry.