Varun Aggarwal, United States of America
Critical Path Institute Quantitative MedicineAuthor Of 1 Presentation
ADVANCING DIGITAL TECHNOLOGIES FOR PARKINSON’S: A PATIENT-CENTRIC STRATEGY
Abstract
Aims
To develop a patient-centric strategy to advance the use of digital health technologies in Parkinson’s disease (PD) clinical trials.
Methods
Three source-domains were defined to generate comprehensive inventories to inform the regulatory strategy for PD: Voice of the Patient (VoP), existing clinical outcome assessments (COAs), and studies employing digital health technologies (DHTs). For VoP, 38 publications were selected for assessment from 69 publications after initial screening. For COAs, 172 COAs from 22 publications identified by the Movement Disorder Society (MDS) task force were screened. For studies employing DHTs, 67 distinct studies were identified.
Results
VoP assessment provided information about clinical manifestations and their importance. Quantitative metrics were used to rank the symptoms important to patients. For the identified symptoms, existing COAs were assessed for limitations in addressing signs and symptoms of PD, and for the possibility of utilizing DHTs to improve clinical assessments. Integration of information from the three source-domains resulted in creating a process flow to assess the maturity of DHTs to monitor clinically meaningful features of PD, and for engaging regulatory agencies. This methodology results in identification of gait, sleep, speech, etc. as more mature concepts in comparison to muscle ache, digestive issues, comprehension etc. on the targeted maturity continuum.
Conclusions
The proposed patient-centric strategy provides a methodology to assess gaps that exist in quantifying PD symptom burden and identify areas to facilitate advancement of DHTs in PD clinical trials. This process assists in identifying symptoms to target for future DHT development and regulatory use in PD drug development.