Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities

Hosono, Takashi; Niwa, Yuki; Kondoh, Masuo

Therapeutic Innovation and Regulatory Science, 2024, 58(6), 1138-1147

Number of Access:362（2025-08-14 07:54 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/98387

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Title
Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
Creator
CreatorName
Hosono, Takashi
NRID
1000020756077 1000020756077
researchmap permalink
yuki_niwa yuki_niwa
CreatorName
Niwa, Yuki
NRID
1000050309697 1000050309697
researchmap permalink
read0083480 read0083480
Scopus Author ID
26643156500 26643156500
CreatorName
Kondoh, Masuo
Subject
Clinical trials
Digital therapeutics
DTx
Insomnia
Sleep disorder
Description
The version of record of this article, first published in Therapeutic Innovation and Regulatory Science, is available online at Publisher’s website: https://doi.org/10.1007/s43441-024-00684-9.
Abstract
Background: Digital therapeutics (DTx) have attracted attention as the substitutes or add-ons to conventional pharmacotherapy and the number of DTx products authorized with the regulatory reviews of the clinical evidence is increasing. Insomnia is one of the major targets of the DTx due to the benefit from cognitive behavioral interventions and several products have been launched in the market with regulatory reviews. However, common features of the products and the clinical evidence required by each regulatory agency have not been investigated. Methods: In this study, we identified the DTx products with the primary indication of insomnia authorized with regulatory reviews of clinical evidence by literature and website searches, and investigated the common features of the products and of the study designs for the pivotal clinical trials. Results: The total of 6 DTx products were identified. The components of cognitive behavioral therapy for insomnia (CBT-I) were identified as common features of the products. All the pivotal clinical trials were randomized, parallel-group, blind studies against insomnia patients. No products have been authorized in multiple countries regardless of the similarity of the features of the products and of the study designs for the pivotal clinical trials. Conclusions: Our study revealed that the components of CBT-I and gold standard design in pivotal clinical trials were adopted in all the DTx products for insomnia authorized with reviews of clinical evidence. At the same time, our findings suggest the needs of internationally harmonized regulatory review and authorization system to facilitate the early patient access to the promising DTx products.
Publisher
Springer Science and Business Media Deutschland GmbH
Source Title
Therapeutic Innovation and Regulatory Science
Volume (Issue)
58(6)
Page
1138-1147
Date of Issued
2024-09-21
Language
English
Handle URL
https://hdl.handle.net/11094/98387
PISSN
21684790
eISSN
21684804
Relation.isIdenticalTo
DOI (Publisher Version)
https://doi.org/10.1007/s43441-024-00684-9
Access Rights
open access
CopyRight
This article is licensed under a Creative Commons Attribution 4.0 International License.
oaire:version
Version of Record
Category
学術雑誌論文 Journal Article