Literature DB >> 32994577

Digital health technologies in clinical trials for central nervous system drugs: an EU regulatory perspective.

Valentina Mantua, Celso Arango, Pavel Balabanov, Florence Butlen-Ducuing.   

Abstract

Mesh:

Substances:

Year:  2021        PMID: 32994577     DOI: 10.1038/d41573-020-00168-z

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN: 1474-1776            Impact factor:   84.694


× No keyword cloud information.
  5 in total

1.  European regulators' views on a wearable-derived performance measurement of ambulation for Duchenne muscular dystrophy regulatory trials.

Authors:  Marion Haberkamp; Jane Moseley; Dimitrios Athanasiou; Fernando de Andres-Trelles; André Elferink; Mário Miguel Rosa; Armando Magrelli
Journal:  Neuromuscul Disord       Date:  2019-06-07       Impact factor: 4.296

Review 2.  A quantitative approach to neuropsychiatry: The why and the how.

Authors:  Martien J Kas; Brenda Penninx; Bernd Sommer; Alessandro Serretti; Celso Arango; Hugh Marston
Journal:  Neurosci Biobehav Rev       Date:  2017-12-12       Impact factor: 8.989

Review 3.  Transforming Psychiatry into Data-Driven Medicine with Digital Measurement Tools.

Authors:  Honor Hsin; Menachem Fromer; Bret Peterson; Collin Walter; Mathias Fleck; Andrew Campbell; Paul Varghese; Robert Califf
Journal:  NPJ Digit Med       Date:  2018-08-22

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

Authors:  Jessie P Bakker; Jennifer C Goldsack; Michael Clarke; Andrea Coravos; Cynthia Geoghegan; Alan Godfrey; Matthew G Heasley; Daniel R Karlin; Christine Manta; Barry Peterson; Ernesto Ramirez; Nirav Sheth; Antonia Bruno; Emilia Bullis; Kirsten Wareham; Noah Zimmerman; Annemarie Forrest; William A Wood
Journal:  NPJ Digit Med       Date:  2019-06-06

Review 5.  Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs).

Authors:  Jennifer C Goldsack; Andrea Coravos; Jessie P Bakker; Brinnae Bent; Ariel V Dowling; Cheryl Fitzer-Attas; Alan Godfrey; Job G Godino; Ninad Gujar; Elena Izmailova; Christine Manta; Barry Peterson; Benjamin Vandendriessche; William A Wood; Ke Will Wang; Jessilyn Dunn
Journal:  NPJ Digit Med       Date:  2020-04-14
  5 in total
  7 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

Review 2.  Novel clinical trial design and analytic methods to tackle challenges in therapeutic development in rare diseases.

Authors:  Yimei Li; Rima Izem
Journal:  Ann Transl Med       Date:  2022-09

Review 3.  Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials.

Authors:  Erica A Smith; William P Horan; Dominique Demolle; Peter Schueler; Dong-Jing Fu; Ariana E Anderson; Joseph Geraci; Florence Butlen-Ducuing; Jasmine Link; Ni A Khin; Robert Morlock; Larry D Alphs
Journal:  Innov Clin Neurosci       Date:  2022 Jan-Mar

Review 4.  Walking on common ground: a cross-disciplinary scoping review on the clinical utility of digital mobility outcomes.

Authors:  Ashley Polhemus; Laura Delgado Ortiz; Gavin Brittain; Nikolaos Chynkiamis; Francesca Salis; Heiko Gaßner; Michaela Gross; Cameron Kirk; Rachele Rossanigo; Kristin Taraldsen; Diletta Balta; Sofie Breuls; Sara Buttery; Gabriela Cardenas; Christoph Endress; Julia Gugenhan; Alison Keogh; Felix Kluge; Sarah Koch; M Encarna Micó-Amigo; Corinna Nerz; Chloé Sieber; Parris Williams; Ronny Bergquist; Magda Bosch de Basea; Ellen Buckley; Clint Hansen; A Stefanie Mikolaizak; Lars Schwickert; Kirsty Scott; Sabine Stallforth; Janet van Uem; Beatrix Vereijken; Andrea Cereatti; Heleen Demeyer; Nicholas Hopkinson; Walter Maetzler; Thierry Troosters; Ioannis Vogiatzis; Alison Yarnall; Clemens Becker; Judith Garcia-Aymerich; Letizia Leocani; Claudia Mazzà; Lynn Rochester; Basil Sharrack; Anja Frei; Milo Puhan
Journal:  NPJ Digit Med       Date:  2021-10-14

Review 5.  Can Innovative Trial Designs in Orphan Diseases Drive Advancement of Treatments for Common Neurological Diseases?

Authors:  Diane Stephenson; Cecile Ollivier; Roberta Brinton; Jeffrey Barrett
Journal:  Clin Pharmacol Ther       Date:  2022-02-07       Impact factor: 6.903

6.  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 7.  Digital Progression Biomarkers as Novel Endpoints in Clinical Trials: A Multistakeholder Perspective.

Authors:  Diane Stephenson; Reham Badawy; Soania Mathur; Maria Tome; Lynn Rochester
Journal:  J Parkinsons Dis       Date:  2021       Impact factor: 5.568

  7 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.