News & Events
November 16, 2022
Empowering drug development: Leveraging insights from imaging technologies to enable the advancement of digital heath technologies
The US Food and Drug Administration (FDA) has publicly recognized the importance of improving drug development efficiency, deeming translational biomarkers a top priority. The use of imaging biomarkers has been associated with increased rates of drug approvals. An appropriate level of validation provides a pragmatic way to choose and implement these biomarkers. Standardizing imaging modality selection, data acquisition protocols, and image analysis (in ways that are agnostic to equipment and algorithms) have been key to imaging biomarker deployment. The best known examples come from studies done via precompetitive collaboration efforts, which enable input from multiple stakeholders and data sharing. Digital health technologies (DHTs) provide an opportunity to measure meaningful aspects of patient health, including patient function, for extended periods of time outside of the hospital walls, with objective, sensor-based measures. We identified the areas where learnings from the imaging biomarker field can accelerate the adoption and widespread use of DHTs to develop novel treatments. As with imaging, technical validation parameters and performance acceptance thresholds need to be established.
Full article: https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.13461#.Y40-0aWn6WU.linkedin
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.
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.
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.
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.