The trend toward digitisation of clinical trials and the myriad benefits that partial or full decentralisation can offer has been proven to reduce costs, shorten the time to market for new therapies and improve ROI.
The questions of digitisation’s impact on drug development are arguably answered, and whilst this has obvious benefits to sponsors, there remain questions regarding the validation and regulatory acceptance of digital endpoints and novel electronic Clinical Outcome Assessments (eCOAs).
In this white paper, we explore our journey to digitise an existing COA and the steps we took to develop, validate, and deploy SARAhome into real-world studies to measure the impact of ataxia on patients’ everyday lives, an approach that enabled us to develop an eCOA where daily or twice daily assessments provide a more meaningful measure of the severity of ataxia than a conventional snapshot visit conducted once a year.
Our white paper examines the past, present and future of ataxia assessments
The past
Since 2004, the clinical scale “Scale of Assessment and Rating of Ataxia (SARA)” presented by Schmitz-Hübsch T et al, 2006 has been used to measure and rate the severity of Ataxia. SARA remains an “in-hospital tool” with poor visibility of the daily fluctuation of patients’ conditions due to the infrequency of hospital visits.
The present
SARAhome uses a video-based assessment delivered via Atom5TM in the patient’s home with no limitation on the frequency of assessments that can be performed which can be reviewed by clinicians via the central assessor platform.
The future
Aparito has demonstrated the feasibility and utility of applying pose-estimation analysis to video-recorded tasks and established the need for standardisation to generate the best results, which will continue to generate newer, more accurate digital endpoints.