Literature DB >> 30009955

How soon will digital endpoints become a cornerstone for future drug development?

Philip Boehme1, Arne Hansen2, Ronenn Roubenoff3, Joseph Scheeren4, Maximilian Herrmann1, Thomas Mondritzki1, Jan Ehlers5, Hubert Truebel6.   

Abstract

Digital technologies are transforming healthcare and will provide the basis for more patient-centric innovation in the pharmaceutical industry. Digital endpoints in clinical studies have the potential to drive innovation and reduce costly late-stage failures. This is also currently under consideration by regulatory agencies, such as the US Food and Drug Administration (FDA). The academic-industrial collaboration MOBILISED-D aims to implement and validate real-world walking speed (RWS) as a digital endpoint accepted by regulatory authorities as a first of its class. Previous work has shown that loss of mobility driven by chronic illness and frailty in older patients can be a relevant readout or effect of different diseases and various organ systems.
Copyright © 2018 Elsevier Ltd. All rights reserved.

Entities:  

Mesh:

Year:  2018        PMID: 30009955     DOI: 10.1016/j.drudis.2018.07.001

Source DB:  PubMed          Journal:  Drug Discov Today        ISSN: 1359-6446            Impact factor:   7.851


  9 in total

Review 1.  A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach.

Authors:  Lynn Rochester; Claudia Mazzà; Arne Mueller; Brian Caulfield; Marie McCarthy; Clemens Becker; Ram Miller; Paolo Piraino; Marco Viceconti; Wilhelmus P Dartee; Judith Garcia-Aymerich; Aida A Aydemir; Beatrix Vereijken; Valdo Arnera; Nadir Ammour; Michael Jackson; Tilo Hache; Ronenn Roubenoff
Journal:  Digit Biomark       Date:  2020-11-26

2.  Consensus based framework for digital mobility monitoring.

Authors:  Felix Kluge; Silvia Del Din; Andrea Cereatti; Heiko Gaßner; Clint Hansen; Jorunn L Helbostad; Jochen Klucken; Arne Küderle; Arne Müller; Lynn Rochester; Martin Ullrich; Bjoern M Eskofier; Claudia Mazzà
Journal:  PLoS One       Date:  2021-08-20       Impact factor: 3.240

3.  BioMeT and Algorithm Challenges: A Proposed Digital Standardized Evaluation Framework.

Authors:  Alan Godfrey; Jennifer C Goldsack; Pamela Tenaerts; Andrea Coravos; Clara Aranda; Azid Hussain; Marcos E Barreto; Fraser Young; Rodrigo Vitorio
Journal:  IEEE J Transl Eng Health Med       Date:  2020-05-28       Impact factor: 3.316

Review 4.  Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science.

Authors:  Diane Stephenson; Robert Alexander; Varun Aggarwal; Reham Badawy; Lisa Bain; Roopal Bhatnagar; Bastiaan R Bloem; Babak Boroojerdi; Jackson Burton; Jesse M Cedarbaum; Josh Cosman; David T Dexter; Marissa Dockendorf; E Ray Dorsey; Ariel V Dowling; Luc J W Evers; Katherine Fisher; Mark Frasier; Luis Garcia-Gancedo; Jennifer C Goldsack; Derek Hill; Janice Hitchcock; Michele T Hu; Michael P Lawton; Susan J Lee; Michael Lindemann; Ken Marek; Nitin Mehrotra; Marjan J Meinders; Michael Minchik; Lauren Oliva; Klaus Romero; George Roussos; Robert Rubens; Sakshi Sadar; Joseph Scheeren; Eiichi Sengoku; Tanya Simuni; Glenn Stebbins; Kirsten I Taylor; Beatrice Yang; Neta Zach
Journal:  Digit Biomark       Date:  2020-11-26

5.  "It's Not as Simple as Just Looking at One Chart": A Qualitative Study Exploring Clinician's Opinions on Various Visualisation Strategies to Represent Longitudinal Actigraphy Data.

Authors:  Alison Keogh; William Johnston; Mitchell Ashton; Niladri Sett; Ronan Mullan; Seamas Donnelly; Jonas F Dorn; Francesc Calvo; Brian Mac Namee; Brian Caulfield
Journal:  Digit Biomark       Date:  2020-11-26

6.  Systematic Review Looking at the Use of Technology to Measure Free-Living Symptom and Activity Outcomes in Parkinson's Disease in the Home or a Home-like Environment.

Authors:  Catherine Morgan; Michal Rolinski; Roisin McNaney; Bennet Jones; Lynn Rochester; Walter Maetzler; Ian Craddock; Alan L Whone
Journal:  J Parkinsons Dis       Date:  2020       Impact factor: 5.568

7.  Opportunities and Challenges for Decentralized Clinical Trials: European Regulators' Perspective.

Authors:  Amos J de Jong; Tessa I van Rijssel; Mira G P Zuidgeest; Ghislaine J M W van Thiel; Scott Askin; Jaime Fons-Martínez; Tim De Smedt; Anthonius de Boer; Yared Santa-Ana-Tellez; Helga Gardarsdottir
Journal:  Clin Pharmacol Ther       Date:  2022-05-17       Impact factor: 6.903

Review 8.  Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review.

Authors:  Ashley Marie Polhemus; Ronny Bergquist; Magda Bosch de Basea; Gavin Brittain; Sara Catherine Buttery; Nikolaos Chynkiamis; Gloria Dalla Costa; Laura Delgado Ortiz; Heleen Demeyer; Kirsten Emmert; Judith Garcia Aymerich; Heiko Gassner; Clint Hansen; Nicholas Hopkinson; Jochen Klucken; Felix Kluge; Sarah Koch; Letizia Leocani; Walter Maetzler; M Encarna Micó-Amigo; A Stefanie Mikolaizak; Paolo Piraino; Francesca Salis; Christian Schlenstedt; Lars Schwickert; Kirsty Scott; Basil Sharrack; Kristin Taraldsen; Thierry Troosters; Beatrix Vereijken; Ioannis Vogiatzis; Alison Yarnall; Claudia Mazza; Clemens Becker; Lynn Rochester; Milo Alan Puhan; Anja Frei
Journal:  BMJ Open       Date:  2020-07-19       Impact factor: 2.692

9.  Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson's Patients Using Digital Mobility Outcomes.

Authors:  Marco Viceconti; Sabina Hernandez Penna; Wilhelmus Dartee; Claudia Mazzà; Brian Caulfield; Clemens Becker; Walter Maetzler; Judith Garcia-Aymerich; Giorgio Davico; Lynn Rochester
Journal:  Sensors (Basel)       Date:  2020-10-20       Impact factor: 3.576

  9 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.