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

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Nature Reviews Drug Discovery 20, 83-84 (2021)



Some of this information has been presented at the ECNP meeting in Copenhagen, Denmark, in September 2019 in the context of a joint ECNP/EMA session entitled “Challenges and perspectives with the use of digital technology in psychiatry”. We would like to acknowledge the ECNP and the other panellists (E. M. Pich, G. Pandina and P. Haselager), for allowing necessary and fruitful interactions between stakeholders in the field, notably EMA, FDA, academia, industry and patient representatives.


The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. V.M. carried out this work when she was still in her former position as an employee of the Italian Medicines Agency (AIFA). Her views are personal and may not be understood or quoted as being made on behalf of or reflecting the position of AIFA or EMA or the US FDA.


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Competing Interests

C.A. has been a consultant to or has received honoraria or grants from Acadia, Angelini, Gedeon Richter, Janssen Cilag, Lundbeck, Minerva, Otsuka, Roche, Sage, Servier, Shire, Schering Plough, Sumitomo Dainippon Pharma, Sunovion and Takeda.

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