2021
Considerations to address missing data when deriving clinical trial endpoints from digital health technologies
Di J, Demanuele C, Kettermann A, Karahanoglu F, Cappelleri J, Potter A, Bury D, Cedarbaum J, Byrom B. Considerations to address missing data when deriving clinical trial endpoints from digital health technologies. Contemporary Clinical Trials 2021, 113: 106661. PMID: 34954098, DOI: 10.1016/j.cct.2021.106661.Peer-Reviewed Original ResearchConceptsStatistical approachFunctional data analysisStatistical methodsRobust modelingImputation approachComplex dataTime series dataSeries dataMissingnessHigh-frequency time series dataStarting pointLearning methodsData analysisApproachSummary measuresModelingImputationDeep learning methodsDigital health technologies
2020
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Stephenson D, Alexander R, Aggarwal V, Badawy R, Bain L, Bhatnagar R, Bloem B, Boroojerdi B, Burton J, Cedarbaum J, Cosman J, Dexter D, Dockendorf M, Dorsey E, Dowling A, Evers L, Fisher K, Frasier M, Garcia-Gancedo L, Goldsack J, Hill D, Hitchcock J, Hu M, Lawton M, Lee S, Lindemann M, Marek K, Mehrotra N, Meinders M, Minchik M, Oliva L, Romero K, Roussos G, Rubens R, Sadar S, Scheeren J, Sengoku E, Simuni T, Stebbins G, Taylor K, Yang B, Zach N. Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science. Digital Biomarkers 2020, 4: 28-49. PMID: 33442579, PMCID: PMC7768153, DOI: 10.1159/000512500.Peer-Reviewed Original ResearchPD clinical trialsParkinson's diseaseDigital health technologiesClinical trialsUse of DHTParkinson’s Disease Drug DevelopmentSymptoms of PDEuropean Medicines AgencyCritical Path InstituteHealth technologiesDrug development studiesClinical manifestationsPD signsRelentless progressionDisease continuumNew therapiesDrug development pipelineNovel treatmentsUS FoodDrug AdministrationMedicines AgencySubsequent approvalDrug developmentCOVID-19 pandemicTherapy
2019
Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research
Badawy R, Hameed F, Bataille L, Little MA, Claes K, Saria S, Cedarbaum JM, Stephenson D, Neville J, Maetzler W, Espay AJ, Bloem BR, Simuni T, Karlin DR. Metadata Concepts for Advancing the Use of Digital Health Technologies in Clinical Research. Digital Biomarkers 2019, 3: 116-132. PMID: 32175520, PMCID: PMC7046173, DOI: 10.1159/000502951.Peer-Reviewed Original ResearchDigital health technologiesMetadata set