Project Scope |
Scope is limited to digital biomarkers usage in Clinical Trials
Problem Statement
Digital biomarkers are defined as objective, quantifiable physiological and behavioural data that are collected and measured by means of digital devices such as portables, wearables, implantables, or digestibles. As an emerging technology, Digital Biomarkers ability in addressing medical challenges is enormous. Project “DB360”, to focus on all areas surrounding Digital Biomarkers and its usage in clinical trials. You can find further information here.
Problem Impact
This project identifies current state of digital biomarkers in clinical sector and its future impact. It will cover the topics: Classification of existing digital biomarkers, Clinical Therapeutic areas where digital biomarkers usage is progressing, limitations, etc., Stakeholders impacted are Pharma, CROs, tech companies, regulators and SDOs. “DB360” will be built on the paper DH08 submitted in PHUSE US Connect 2020 with finalThe project will introduce and identify the current state of topics relating to the usage of digital health technologies in clinical trials and regulatory submissions:
The project will also provide a common platform to discuss regulatory guidance around DHT. |
| Problem Statement |
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Digital biomarkers cannot be explained without providing context to the larger eco-system of digital health technology (DHT). Digital health technology has been growing rapidly in recent years, and this trend is expected to continue. The COVID-19 pandemic has also accelerated the adoption of digital health technologies as people have become more accustomed to receiving healthcare services remotely. |
| Problem Impact |
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We are requesting to change the Digital Biomarker Working Group project with Digital Health Technology. Navigating the regulatory landscape for digital health technologies can be challenging. Companies need to be proactive in understanding the regulatory requirements that apply to their products and work closely with regulators to ensure they are meeting these requirements in a timely and efficient manner. |
| Project Leads | |
|---|---|
| Vijay Pasapula |
| , Cerus |
| VPasapula@cerus.com | |
| Unnat Patel |
| , AnalysisMate |
| unnat.patel@analysismate.com |
| Kerry Robson, PHUSE Project Assistant |
PHUSE Connect 2022 poster and presentation recording
Determination of sub-topics to expand further
Draft of few sub-topics for White Paper
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- Developing sub-topics for a White Paper presentation which will be focused on identifying issues such as data sources, RWE technologies, data privacy and related issues, and standards
- Poster abstract approval for the PHUSE Connect 2022
- Sub-topics research expanded
Q1 2024 |
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White paper on digital health technologies |
| Objectives & Deliverables | Timelines |
|---|---|
| Produce a poster / paper for US Connect | Q1 2024 |
Produce a White Paper | Q3 2024 |
Deliver a presentation at a PHUSE Single Day Event on DHTs | Q3 2023 |
Sanofi
Subhayan Das
Zahra Karimaddini