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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 final outcome of White Paper and presentations at PHUSE conferences in 2022

Project LeadsEmail
Paula Rowley (PHUSE Project Assistant) 


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. 

Project MembersOrganisation
Erin ErginerPinnacle 21
Gianna HuangGilead Sciences
 Ippei AkiyaA2 Healthcare Corporation
Jing SuMerck
Kunal BanshingeSpringer Nature
Lavanya Sundaram


Manohara HalasiddappaAlgok Bio
Naseem Buckley Takeda
Neetu SangariPfizer

Subhayan Das

Bristol Myers Squibb
SungHo LimGenentech
Tao GuGilead Sciences
Teckla AkinyiGSK
Unnat Patel AnalysisMate

Zahra Karimaddini

Objectives & DeliverablesTimelines

Existing digital biomarkers classification (Q3/Q4)

Identifying Clinical Trials Therapeutic Areas where DBs are using DB'sQ3-Q42021
Identify the limitations of usage of digital biomarker in clinical trials Q42021/Q12022
Deep dive into the areas identified during learning process and possible white paper, conference presentation during PHUSE CONNECT/CSS, 2022

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