October 16, 2023 Transforming Drug Development for Neurological Disorders: Proceedings from a Multidisease Area Workshop Neurological disorders represent some of the most challenging therapeutic areas for successful drug approvals.
November 16, 2022 Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital heath technologies
March 28, 2022 Digital Health Technologies for Remote Data Acquisition in Clinical Investigations C-Path thanks and commends FDA for inviting public comments as part of the creation of a guidance document for Digital Health...
March 18, 2022 Metadata Framework to Support Deployment of Digital Health Technologies in Clinical Trials in Parkinson’s Disease Sensor data from digital health technologies (DHTs) used in clinical trials provides a valuable source of information...
August 1, 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...
July 8, 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...
January 8, 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....
November 10, 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 BR, Boroojerdi B, Burton J, Cedarbaum JM, Cosman...
August 16, 2020 Remote Digital Monitoring for Medical Product Development Izmailova ES, Wagner JA, Ammour N, Amondikar N, Bell‐Vlasov A, Berman S, Bloomfield D, Brady LS, Cai X, Calle RA, Campbell M...
December 5, 2019 Development of a Disease Progression Model for Leucine-Rich Repeat Kinase 2 in Parkinson’s Disease to Inform Clinical Trial Designs Ahamadi M, Conrado DJ, Macha S, Sinha V, Stone J, Burton J, Nicholas T, Gallagher J, Dexter D, Bani M, Boroojerdi B, Smit H...