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
Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease
Romero K, Conrado D, Burton J, Nicholas T, Sinha V, Macha S, Ahamadi M, Cedarbaum J, Seibyl J, Marek K, Basseches P, Hill D, Somer E, Gallagher J, Dexter DT, Roach A, Stephenson D, Consortium F, Initiative T. Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson's Disease. Clinical And Translational Science 2019, 12: 240-246. PMID: 30706986, PMCID: PMC6510371, DOI: 10.1111/cts.12619.Peer-Reviewed Original ResearchConceptsClinical trialsImaging biomarkersDopamine transporterEuropean Medicines Agency's CommitteeParkinson's disease clinical trialsEarly Parkinson's diseaseCritical Path InstitutePatient selectionEnrichment biomarkerParkinson's diseaseMolecular neuroimagingPharmaceutical partnersDiseaseBiomarkersTrialsQualification opinionHuman useInternational ConsortiumTransportersMedical productsNeuroimaging