Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science
Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the dr...
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doaj-02833b80db5e4df4916766e3401c16662020-12-23T15:11:39ZengKarger PublishersDigital Biomarkers2504-110X2020-11-0141284910.1159/000512500512500Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory ScienceDiane StephensonRobert AlexanderVarun AggarwalReham BadawyLisa BainRoopal BhatnagarBastiaan R. BloemBabak BoroojerdiJackson BurtonJesse M. CedarbaumJosh CosmanDavid T. DexterMarissa DockendorfE. Ray DorseyAriel V. DowlingLuc J. W. EversKatherine FisherMark FrasierLuis Garcia-GancedoJennifer C. GoldsackDerek HillJanice HitchcockMichele T. HuMichael P. LawtonSusan J. LeeMichael LindemannKen MarekNitin MehrotraMarjan J. MeindersMichael MinchikLauren OlivaKlaus RomeroGeorge RoussosRobert RubensSakshi SadarJoseph ScheerenEiichi SengokuTanya SimuniGlenn StebbinsKirsten I. TaylorBeatrice YangNeta ZachInnovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies.https://www.karger.com/Article/FullText/512500digital health technologiesregulatory sciencepublic-private partnershipscollaborationconsensusdevice agnostic |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science Digital Biomarkers digital health technologies regulatory science public-private partnerships collaboration consensus device agnostic |
author_facet |
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 |
author_sort |
Diane Stephenson |
title |
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science |
title_short |
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science |
title_full |
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science |
title_fullStr |
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science |
title_full_unstemmed |
Precompetitive Consensus Building to Facilitate the Use of Digital Health Technologies to Support Parkinson Disease Drug Development through Regulatory Science |
title_sort |
precompetitive consensus building to facilitate the use of digital health technologies to support parkinson disease drug development through regulatory science |
publisher |
Karger Publishers |
series |
Digital Biomarkers |
issn |
2504-110X |
publishDate |
2020-11-01 |
description |
Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson’s Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies. |
topic |
digital health technologies regulatory science public-private partnerships collaboration consensus device agnostic |
url |
https://www.karger.com/Article/FullText/512500 |
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