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

doi:https://doi.org/10.1007/s43441-024-00684-9

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

アクセス数:378件（2025-09-29 11:30 集計）

固定URL: https://hdl.handle.net/11094/98387

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タイトル	Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
著者	著者名 Hosono, Takashi
	NRID 1000020756077 1000020756077 researchmap permalink yuki_niwa yuki_niwa 著者名 Niwa, Yuki
	NRID 1000050309697 1000050309697 researchmap permalink read0083480 read0083480 Scopus Author ID 26643156500 26643156500 著者名 Kondoh, Masuo
キーワード等	Clinical trials
	Digital therapeutics
	DTx
	Insomnia
	Sleep disorder
内容	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.
抄録	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.
出版者	Springer Science and Business Media Deutschland GmbH
収録物名	Therapeutic Innovation and Regulatory Science
巻(号)	58(6)
ページ	1138-1147
刊行年月	2024-09-21
言語	英語
ハンドルURL	https://hdl.handle.net/11094/98387
PISSN	21684790
eISSN	21684804
関連情報 (isIdenticalTo)	DOI (出版社版) https://doi.org/10.1007/s43441-024-00684-9
アクセス権	open access
権利情報	This article is licensed under a Creative Commons Attribution 4.0 International License.
出版タイプ	Version of Record
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCTERMS.bibliographicCitation	Therapeutic Innovation and Regulatory Science. 2024, 58(6), p. 1138-1147
DC.title	Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
DC.creator	Hosono, Takashi
	Niwa, Yuki
	Kondoh, Masuo
DC.publisher	Springer Science and Business Media Deutschland GmbH
DC.language' scheme='DCTERMS.RFC1766	英語
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-09-21
DC.identifier	https://doi.org/10.1007/s43441-024-00684-9
DC.subject	Clinical trials
	Digital therapeutics
	DTx
	Insomnia
	Sleep disorder
DC.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.
DCTERMS.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.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	98387
citation_title	Comparison of Product Features and Clinical Trial Designs for the DTx Products with the Indication of Insomnia Authorized by Regulatory Authorities
citation_author	Hosono, Takashi
	Niwa, Yuki
	Kondoh, Masuo
citation_publisher	Springer Science and Business Media Deutschland GmbH
citation_language	英語
citation_date	2024-09-21
citation_journal_title	Therapeutic Innovation and Regulatory Science
citation_volume	58
citation_issue	6
citation_firstpage	1138
citation_lastpage	1147
citation_doi	https://doi.org/10.1007/s43441-024-00684-9
citation_public_url	https://hdl.handle.net/11094/98387

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

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