Methods for Analytical Validation of Novel Digital Clinical Measures: Implementation Feasibility Evaluation Using Real-World Datasets

Simon Turner   ¹ , PhD ;   Lysbeth Floden   ² , PhD ;   Leif Simmatis   ³ , PhD ;   Piper Fromy   ⁴ , PhD ;   Joss Langford   ^{5, 6} , BSc ;   Eric J Daza   ⁷ , DrPH ;   Andrew Potter   ⁸ , PhD ;   Kathleen Troeger   ¹ , MPH ;   the STAGES cohort investigator group   ⁹

¹ Digital Medicine Society, Boston, MA, United States

² Quantitative Science, Evinova, Waltham, MA, United States

³ Department of Speech-Language Pathology, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada

⁴ Seeing Theta, Saumur, France

⁵ Activinsights Ltd., Kimbolton, Cambridgeshire, United Kingdom

⁶ Department of Public Health and Sport Sciences, University of Exeter, Exeter, United Kingdom

⁷ Stats-of-1, Menlo Park, CA, United States

⁸ Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, United States

⁹ Stanford University, Stanford, CT, United States