Use of Bayesian decision analysis to maximize value in patient-centered randomized clinical trials in Parkinson's disease.

Autor: Chaudhuri SE; Laboratory for Financial Engineering, MIT Sloan School of Management, Cambridge, MA, USA., Ben Chaouch Z; Laboratory for Financial Engineering, MIT Sloan School of Management, Cambridge, MA, USA.; Electrical Engineering and Computer Science Department, MIT, Cambridge, MA, USA., Hauber B; RTI Health Solutions, Research Triangle Park, NC, USA.; CHOICE Institute, University of Washington School of Pharmacy, Seattle, WA, USA., Mange B; RTI Health Solutions, Research Triangle Park, NC, USA., Zhou M; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Christopher S; Medical Device Innovation Consortium, Arlington, VA, USA., Bardot D; Medical Device Innovation Consortium, Arlington, VA, USA., Sheehan M; Patient Council, The Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA., Donnelly A; Patient Council, The Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA., McLaughlin L; Strategy and Planning, The Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA., Caldwell B; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Benz HL; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Ho M; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Saha A; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Gwinn K; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Sheldon M; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Lo AW; Laboratory for Financial Engineering, MIT Sloan School of Management, Cambridge, MA, USA.; Computer Science and Artificial Intelligence Laboratory, MIT, Cambridge, MA, USA.; Santa Fe Institute, Santa Fe, NM, USA.

Publikováno v: Journal of biopharmaceutical statistics [J Biopharm Stat] 2023 Mar 02, pp. 1-20. Date of Electronic Publication: 2023 Mar 02.

Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson's Disease.

Autor: Benz HL; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland., Caldwell B; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland., Ruiz JP; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland., Saha A; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland., Ho M; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland., Christopher S; Medical Device Innovation Consortium, Arlington, Virginia., Bardot D; Medical Device Innovation Consortium, Arlington, Virginia., Sheehan M; The Michael J. Fox Foundation for Parkinson's Research, New York, New York., Donnelly A; The Michael J. Fox Foundation for Parkinson's Research, New York, New York., McLaughlin L; The Michael J. Fox Foundation for Parkinson's Research, New York, New York., Mange B; RTI Health Solutions, Research Triangle Park, North Carolina., Hauber AB; RTI Health Solutions, Research Triangle Park, North Carolina., Gwinn K; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland., Heetderks WJ; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland., Sheldon M; US FDA Center for Devices and Radiological Health, Silver Spring, Maryland.

Publikováno v: MDM policy & practice [MDM Policy Pract] 2021 Jul 02; Vol. 6 (1), pp. 23814683211021380. Date of Electronic Publication: 2021 Jul 02 (Print Publication: 2021).

Changes in human brain dynamics during behavioral priming and repetition suppression.

Autor: Korzeniewska A; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA. Electronic address: akorzen@jhmi.edu., Wang Y; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA., Benz HL; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA., Fifer MS; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA., Collard M; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA., Milsap G; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA., Cervenka MC; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA., Martin A; Laboratory of Brain and Cognition, National Institute of Mental Health, Bethesda, Maryland, 20852, USA., Gotts SJ; Laboratory of Brain and Cognition, National Institute of Mental Health, Bethesda, Maryland, 20852, USA., Crone NE; Department of Neurology, Johns Hopkins University, Baltimore, Maryland, 21287, USA.

Publikováno v: Progress in neurobiology [Prog Neurobiol] 2020 Jun; Vol. 189, pp. 101788. Date of Electronic Publication: 2020 Mar 18.

Advancing the Use of Patient Preference Information as Scientific Evidence in Medical Product Evaluation: A Summary Report of the Patient Preference Workshop.

Autor: Benz HL; FDA Center for Devices and Radiological Health, Silver Spring, MD, USA. heather.benz@fda.hhs.gov.; FDA Center for Biologics Evaluation and Research, Silver Spring, MD, USA. heather.benz@fda.hhs.gov., Lee TJ; FDA Center for Devices and Radiological Health, Silver Spring, MD, USA., Tsai JH; Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, Baltimore, MD, USA.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.; Pharmerit International, Bethesda, USA., Bridges JFP; Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, Baltimore, MD, USA.; Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.; Ohio State University, Columbus, USA., Eggers S; FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA., Moncur M; FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.; FDA Center for Biologics Evaluation and Research, Silver Spring, MD, USA., Shaya FT; University of Maryland Center of Excellence in Regulatory Science and Innovation, Baltimore, MD, USA., Shoulson I; Georgetown University Center of Excellence in Regulatory Science and Innovation, Washington, DC, USA., Spatz ES; Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation, New Haven, CT, USA., Wilson L; UCSF-Stanford Center of Excellence in Regulatory Science and Innovation, San Francisco, CA, USA., Saha A; FDA Center for Devices and Radiological Health, Silver Spring, MD, USA.

Publikováno v: The patient [Patient] 2019 Dec; Vol. 12 (6), pp. 553-557.

Identifying and prioritizing concerns associated with prosthetic devices for use in a benefit-risk assessment: a mixed-methods approach.

Autor: Janssen EM; a Department of Health Policy and Management , Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.; b Johns Hopkins Bloomberg School of Public Health , Johns Hopkins Center of Excellence in Regulatory Science and Innovation , Baltimore , MD , USA., Benz HL; c Center for Devices and Radiological Health, U.S. Food and Drug Administration , Silver Spring , MD , USA., Tsai JH; a Department of Health Policy and Management , Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA., Bridges JF; a Department of Health Policy and Management , Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.; b Johns Hopkins Bloomberg School of Public Health , Johns Hopkins Center of Excellence in Regulatory Science and Innovation , Baltimore , MD , USA.

Publikováno v: Expert review of medical devices [Expert Rev Med Devices] 2018 May; Vol. 15 (5), pp. 385-398. Date of Electronic Publication: 2018 May 08.