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

Contemporary Clinical Trials
Volume 91 April 2020
https://www.sciencedirect.com/journal/contemporary-clinical-trials/vol/91/suppl/C

 

Special Interest Papers
Review article Open access
Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials
Mobile sensors offer enormous potential for the collection of informative clinical endpoints in clinical trials to support regulatory decision making and product labelling. There are currently no specific guidelines on the information needed to enable regulators to review and accept proposed endpoints derived from mobile sensors for use in drug development trials.
M.K. Walton, J.C. Cappelleri, B. Byrom, J.C. Goldsack, … M. Daumer
Article 105962