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
2015
Commonalities and Challenges in the Development of Clinical Trial Measures in Neurology
Cedarbaum JM, Stephenson D, Rudick R, Carrillo MC, Stebbins G, Kerr D, Heemskerk J, Galpern WR, Kaufmann P, Cella D, Isaac M, Walton MK. Commonalities and Challenges in the Development of Clinical Trial Measures in Neurology. Neurotherapeutics 2015, 12: 151-169. PMID: 25384682, PMCID: PMC4322066, DOI: 10.1007/s13311-014-0310-1.Peer-Reviewed Original ResearchConceptsOutcome measuresNeurological disordersDisease-specific outcome measuresClinical trial measuresAssessment of dysfunctionAutonomic system functionMotor functionNervous systemRelated disordersDisordersDisease areasAmerican SocietyDrug developmentDysfunctionTrial measuresTerms of cognitionNeurologyAssessment developmentSystem functionAnnual MeetingNeurologistsSymptomsNeurotherapeutics