What is it about?
Digital devices can help monitor diseases, and in drug development clinical trials they can transform study performance. Until now such productivity impact was not quantified. We created an innovative method using Monte Carlo simulation to overcome the uncertainties of new technologies in clinical studies.
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Why is it important?
Many pharmaceutical companies sponsor digital innovation activities to transform drug development productivity, but the vast majority of projects do not proceed further than experimental pilots. Clinical sponsors and technology providers need a common framework to estimate the benefits of digital biomarkers. With quantified and agreed impact, digital biomarker development and validation can take place.
Perspectives
Clinical trials are at the heart of pharmaceutical industry, but digital transformation has been slow despite the recent advances in wearable technologies. Innovators need to communicate the operational and productivity benefits to the clinical teams in order for the novel solutions to be adopted. Clinical trials are uncertain and so are the upcoming digital biomarkers. Monte Carlo simulation gave us a way to illustrate the difference between using digital biomarkers and without. My favourite film Moneyball gave me an idea to try out.
Hiromasa Mori
Read the Original
This page is a summary of: Quantifying the Benefits of Digital Biomarkers and Technology-Based Study Endpoints in Clinical Trials: Project Moneyball, Digital Biomarkers, June 2022, Karger Publishers,
DOI: 10.1159/000525255.
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