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DiMe Publications

Publications

Personalized therapies in the Future of Health: Winning with digital medicine products

In partnership with our colleagues at the Deloitte Center for Health Solutions, DiMe collaborated on the report, “Personalized therapies in the Future of Health: Winning with digital medicine products,” which proposes a framework for successful partnerships between pharma and tech companies.

March 2021 in Deliotte Insights

Publications

When fitness data becomes research data, your privacy may be at risk

DiMe leadership illustrate the risk of sharing anonymized fitness data and call for systematic reform.

February 2021 in MobiHealth News

Publications

Evaluation, Acceptance, and Qualification of Digital Measures: From Proof of Concept to Endpoint

To support the successful adoption of digital measures into internal decision making and evidence generation for medical product development, experts present a unified lexicon to aid communication throughout this process, and highlight key concepts including the critical role of participant engagement in development of digital measures.

January 2021 in Digital Biomarkers

Publications

Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science

DiMe experts co-authored this publication on how the advancement of DHT can be most effectively be achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies; and additionally, can specifically support the advancement of Parkinson Disease treatments.

December 2020 in Karger Digital Biomarkers

Publications

Defining and Developing the Workforce Needed for Success in the Digital Era of Medicine

DiMe experts co-authored this publication on how the advancement of DHT can be most effectively be achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies; and additionally, can specifically support the advancement of Parkinson Disease treatments.

December 2020 in Karger Digital Biomarkers

Publications

The Playbook: Digital Clinical Measures

The Playbook is the essential guide for developing & deploying digital clinical measures across clinical research, clinical care, and population health surveillance. The first draft was developed by a collaboration between DiMe, Elektra Labs, FDA, Genentech, Koneksa Health, Myokardia, Sage Bionetworks, and Scripps Research.

September 2020 on https://playbook.dimesociety.org/

Publications

Digital Measures That Matter to Patients: A Framework to Guide the Selection and Development of Digital Measures of Health

DiMe leadership synthesizes and defines a framework of core principles for selecting and developing measurements in research and clinical care that are meaningful for patients.

September 2020 in Karger Digital Biomarkers

Publications

An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID‐19

DiMe leadership dicusses how remote monitoring systems using BioMeTs can monitor patients with mild COVID‐19 symptoms at home and patients discharged from the hospital after initial improvement for an acute worsening later in their course.

August 2020 in Clinical and Translational Science

Publications

With Covid-19 halting clinical trials, wearables could be key — but data ‘wild west’ gets in the way

Jordan Bryanov and DiMe leaders Jen Goldsack and Bill Byrom advocate for the biotech, pharma, and tech sectors to work together and leverage their collective purchasing power to drive the adoption of common standards to scale the use of digital clinical measures in clinical research.

August 2020 in STAT News

Publications

Fit‐for‐Purpose Biometric Monitoring Technologies (BioMeT): Leveraging the Laboratory Biomarker Experience

DiMe’s Research Committee work group complted its first project with this publication. This manuscript addresses the need for a more robust regulatory framework that includes thorough verification, analytical validation, and clinical validation, as well as biomarker qualification evidentiary guidance from the FDA.

August 2020 in Clinical and Translational Science

Publications

Underuse of Oral Anticoagulants in Privately Insured Patients with Atrial Fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to ImProve treatment with Oral AntiCoagulanTs in patients with atrial fibrillation (IMPACT-AFib)

Several members of DiMe’s leadership participated in a study, published in the American Heart Journal, concludes that there is an unmet need for evidence-based interventions that could lead to greater use of OACs in patients with AF at risk for stroke.

July 2020 in American Heart Journal

Publications

Remote Digital Monitoring for Medical Product Development

A large contingent of DiMe experts contributed to describing key takeaways and calls to action following an outstanding workshop organized by the FNIH Biomarker Consortium.

July 2020 in Clinical and Translational Science

Publications

Remote Monitoring in Clinical Trials During the COVID‐19 Pandemic

In response to the increased demand for remote trials driven by COVID-19, DiMe experts propose a decision tree to support the migration of clinic-to-remote assessments and highlight activities required to ensure that remote measurements are valid, safe, and usable

June 2020 in Clinical and Translational Science

Publications

Remote digital monitoring in clinical trials in the time of COVID-19

With contributions from our DiMe leadership, this brief describes key points from the FNIH workshop on remote digital monitoring in medical product development.

May 2020 in Nature Reviews Drug Discovery

Publications

BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework

DiMe members and colleagues offer pragmatic guidance regarding BioMeTs, culminating in a proposed framework to advance their development and deployment in healthcare, health research, and health promotion. The framework proposes a process to establish an audit trail of BioMeTs.

May 2020 in IEEE Journal of Translational Engineering in Health and Medicine

Publications

Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

DiMe collaborates to establishe core terminology to enable more effective communication, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field.

April 2020 in NPJ Digital Medicine

Publications

Why V3 (verification, analytical validation, and clinical validation)?

DiMe experts elloborate on our V3 publication in NPJ Digital Medicine in this companion piece.

April 2020 in NPJ Digital Medicine

Publications

Using connected sensor technologies to measure health at home

DiMe members outline frameworks and processes to evaluate the risks and benefits of connected sensor technologies at home in a companion piece to their NPJ Digital Medicine publication.

April 2020 in NPJ Digital Medicine

Publications

Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials

With contribution from our DIMe leadership, this report provides a considered approach tocompiling a comprehensive body of evidence to justify acceptance of mobile sensors for support of new drug applications.

April 2020 in Contemporary Clinical Trials

Publications

Modernizing and designing evaluation frameworks for connected sensor technologies in medicine

DiMe colleagues provide a pragmatic guide for designing an evaluation framework for wearables amd connected sensor technologies.

March 2020 in NPJ Digital Medicine

Publications

mHealth and patient generated health data: stakeholder perspectives on opportunities and barriers for transforming healthcare

DiMe member Debbe McCall co-authored this article on the collection of patient-generated health data and its potential impact on efficient care.

September 20, 2019 in mHealth

Publications

Advancing the Use of Mobile Technologies in Clinical Trials: Recommendations from the Clinical Trials Transformation Initiative

Many DiMe members contributed to the Clinical Trials Transformation Initiative (CTTI) recommendations published here.

November 6, 2019 in Digital Biomarkers

Publications

Digital endpoints library can aid clinical trials for new medicines

DiMe leadership describe the importance of our library of digital endpoints in this STAT News First Opinion piece.

Novemer 6, 2019 in Stat News

Publications

The Digital Medicine Society (DiMe): advancing the use of digital medicine to optimize health

During the 2019 CNS Summit, DiMe leadership presented an abstract on our work to advance the field of digital medicine.

October 31, 2019 in Innovations in Clinical Neuroscience

Publications

Mind the Gap: The Ethics Void Created by the Rise of Citizen Science in Health and Biomedical Research

DiMe SLB member, Bray Patrick-Lake, and Jennifer Goldsack contributed this editorial to a special issue on citizen science.

July 24, 2019 in The American Journal of Bioethics

Publications

Invisible work and changing roles: Health information technology implementation and reorganization of work practices for the inpatient nursing team

With sociologist Dr. Meredith Bergey, DiMe’s Jennifer Goldsack and Edmondo Robinson published qualitative research from the inpatient setting.

June 27, 2019 in Social Science & Medicine

Publications

A systematic review of feasibility studies promoting the use of mobile technologies in clinical research

DiMe leadership contributed to this Clinical Trials Transformation Initiative (CTTI) systematic review and living database of feasibility studies of mobile technologies for use in clinical trials.

June 6, 2019 in NPJ Digital Medicine

Publications

DiMe: Calling all who serve in digital medicine

In this OpEd Jen Goldsack, Beau Woods and Eric Perakslis describe how DiMe is building a digital medicine community to advance the field for the greatest good.

June 5, 2019 in STAT News

Publications

Introducing the Digital Medicine Society (DiMe)

Learn about why DiMe co-founder, Andy Coravos, and Scientific Leadership Board member, Bray Patrick-Lake, believe in an important future for DiMe.

May 29, 2019 in Duke Forge Blog

Publications

A New Chapter

Editor-in-Chief of Digital Biomarkers, and member of the DiMe Scientific Leadership Board, highlights the role we all can play in realizing the potential of digital tools to improve health.

May 20, 2019 in Digital Biomarkers

Publications

Tech world and medicine come together to harness digital medicine

Members of DiMe’s Strategic Advisory Board and Scientific Leadership board describe the evolving field of digital medicine and reflect on the role of supporting organizations.

May 17, 2019 in Maturitas

Publications

Digital Medicine: A Primer on Measurement

DiMe’s first publication provides a brief introduction to the core concepts and terms that define digital medicine.

May 10, 2019 in Digital Biomarkers

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