News & Events
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March 28, 2022
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
The Clinical Outcomes Assessment (COA), Critical Path for Parkinson’s Digital Drug Development (3DT) Initiative, and Type 1 Diabetes (T1D) Consortia all contributed to this effort, resulting in a combined set of comments on behalf of C-Path. By bringing together stakeholders across industry, regulatory agencies, patient groups, academic researchers and clinicians, disease foundations and other organizations aiming to improve patients’ lives, C-Path hopes these comments will provide helpful feedback on how DHT (Digital Health Technologies) are used to accelerate a path to a healthier world.
We thank and commend FDA for the opportunity to provide comments and look forward to future developments in this area.
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March, 2022
Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson’s Disease
Hill DL, Stephenson D, Brayanov J, Claes K, Badawy R, Sardar S, Fisher K, Lee SJ, Bannon A, Roussos G, Kangarloo T, Terebaite V, Müller MLTM, Bhatnagar R, Adams JL, Dorsey ER, Cosman J. Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson’s Disease. Sensors. 2022; 22(6):2136.
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August, 2021
A Disease Progression Model to Quantify the Nonmotor Symptoms of Parkinson’s Disease in Participants With Leucine-Rich Repeat Kinase 2 Mutation
Ahamadi M, Mehrotra N, Hanan N, Lai Yee K, Gheyas F, Anton J, Bani M, Boroojerdi B, Smit H, Weidemann J, Macha S, Thuillier V, Chen C, Yang M, Williams-Gray CH, Stebbins GT, Pagano G, Hang Y, Marek K, Venuto CS, Javidnia M, Dexter D, Pedata A, Stafford B, Akalu M, Stephenson D, Romero K, Sinha V; Critical Path for Parkinson’s Consortium. A Disease Progression Model to Quantify the Nonmotor Symptoms of Parkinson’s Disease in Participants With Leucine-Rich Repeat Kinase 2 Mutation. Clin Pharmacol Ther. 2021 Aug;110(2):508-518.
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2021
Digital Progression Biomarkers as Novel Endpoints in Clinical Trials: A Multistakeholder Perspective
Stephenson D, Badawy R, Mathur S, Tome M, Rochester L. Digital Progression Biomarkers as Novel Endpoints in Clinical Trials: A Multistakeholder Perspective. J Parkinsons Dis. 2021;11(s1):S103-S109.
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January, 2021
Effective Data Sharing as a Conduit for Advancing Medical Product Development
Karpen SR, White JK, Mullin AP, O’Doherty I, Hudson LD, Romero K, Sivakumaran S, Stephenson D, Turner EC, Larkindale J. Effective Data Sharing as a Conduit for Advancing Medical Product Development. Ther Innov Regul Sci. 2021 May;55(3):591-600