Keywords: actigraphy, clinical study endpoints, methodology, analysis, regulatory science
There is growing interest in the integration of activity monitoring methods, such as actigraphy, into clinical trials to generate data in support of clinical benefit endpoints. While actigraphy has gained popularity (e.g., in sleep and itch research), questions remain about the utility, reliability and validity of this method within the regulatory context. Further discussion regarding issues related to determining the most appropriate data collection, data processing, and data analysis methods is needed to ensure that actigraphy data can adequately support regulatory decision-making. This presentation will provide an overview of methodological considerations related to the use of actigraphy in clinical trials. Additionally, we will offer the regulatory perspective on challenges related to actigraphy data analysis and score interpretation and provide insight into data elements (e.g., data processing rules, scoring algorithms, and threshold sensitivity levels) that will help increase the likelihood of regulatory acceptance.