Regulatory oversight of behavioral digital therapeutics for addiction treatment: A commentary on Khadjesari <i>et al</i>.

Vilardaga, Roger; McClernon, F. Joseph

doi:10.1111/add.15690

Cited by 4 publications

(8 citation statements)

References 8 publications

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“…The α 2A -and α 2C -adrenoceptors form homodimers [2192]. Heterodimers between α 2A -and either the α 2c -adrenoceptor or μ opioid peptide receptor exhibit altered signalling and trafficking properties compared to the individual receptors [2192,2315,2443]. Signalling by α 2 -adrenoceptors is primarily via G i/o , although the α 2A -adrenoceptor also couples to G s [577].…”

Section: Adrenoceptorsmentioning

confidence: 99%

THE CONCISE GUIDE TO PHARMACOLOGY 2021/22: G protein‐coupled receptors

Alexander

Christopoulos

Davenport

et al. 2021

British J Pharmacology

385

274

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The Concise Guide to PHARMACOLOGY 2021/22 is the fifth in this series of biennial publications. The Concise Guide provides concise overviews, mostly in tabular format, of the key properties of nearly 1900 human drug targets with an emphasis on selective pharmacology (where available), plus links to the open access knowledgebase source of drug targets and their ligands (https://www.guidetopharmacology.org), which provides more detailed views of target and ligand properties. Although the Concise Guide constitutes over 500 pages, the material presented is substantially reduced compared to information and links presented on the website. It provides a permanent, citable, point‐in‐time record that will survive database updates. The full contents of this section can be found at http://onlinelibrary.wiley.com/doi/bph.15538. G protein‐coupled receptors are one of the six major pharmacological targets into which the Guide is divided, with the others being: ion channels, nuclear hormone receptors, catalytic receptors, enzymes and transporters. These are presented with nomenclature guidance and summary information on the best available pharmacological tools, alongside key references and suggestions for further reading. The landscape format of the Concise Guide is designed to facilitate comparison of related targets from material contemporary to mid‐2021, and supersedes data presented in the 2019/20, 2017/18, 2015/16 and 2013/14 Concise Guides and previous Guides to Receptors and Channels. It is produced in close conjunction with the Nomenclature and Standards Committee of the International Union of Basic and Clinical Pharmacology (NC‐IUPHAR), therefore, providing official IUPHAR classification and nomenclature for human drug targets, where appropriate.

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Section: Adrenoceptorsmentioning

confidence: 99%

THE CONCISE GUIDE TO PHARMACOLOGY 2021/22: G protein‐coupled receptors

Alexander

Christopoulos

Davenport

et al. 2021

British J Pharmacology

385

274

View full text Add to dashboard Cite

show abstract

“…If mHealth solutions are to live up to their appealing claim of offering low-cost, scalable and tailored interventions, it is critical that future research not only adopts meaningful co-design with end-users, but that the target populations are also represented in the studies establishing their effectiveness. Indeed, academics have recently argued that the wide availability of digital therapeutics will not guarantee an equitable public health impact and could potentially amplify the ‘digital divide’ among vulnerable patient populations [34].…”

Section: Discussionmentioning

confidence: 99%

The current evidence for substance use disorder apps

Manning

Whelan

Piercy

2022

Current Opinion in Psychiatry

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Purpose of reviewNew mHealth (smartphone) apps for substance use disorders (SUD) are emerging at an accelerated rate, with consumer choice typically guided by app-store user ratings rather than their effectiveness. The expansive reach, low-cost and accessibility of mHealth apps have driven their popularity and appeal as alternatives to traditional treatment; as such, rigorously establishing their effectiveness is of paramount importance. Recent findingsSeveral systematic reviews conclude that the evidence-base for mHealth SUD apps is weak, inconclusive and hampered by substantial heterogeneity in study designs. However, there have been a number of interesting and novel developments in this area in recent years, which have not been synthesised to date. SummaryMost mHealth apps deliver either multiple-component behaviour change techniques, discrete psychological interventions or cognitive training interventions, or are designed to act as adjuncts to facilitate the delivery of clinical or continuing care. There are promising signals of their feasibility, acceptability and preliminary effectiveness in numerous open-label pilot studies of mHealth apps targeting alcohol and smoking. However, only a handful of sufficiently-powered, well-designed randomised controlled trials have been conducted to date with mixed findings. Furthermore, there has been limited recent attention on mHealth apps aiming to improve outcomes for individuals using other drugs.

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“…In addition, since DTx store user data in digital form, there is a risk of leakage of sensitive personal data; therefore, additional preventative cyber security is required. The clinical challenge of pharmacotherapy is considered as a blood-brain barrier in drugs for neurological disease; however, for DTx, patient engagement is considered a major factor in determining the success of treatment in the future as it presupposes active participation of the patient 14 .…”

Section: Characteristics Of Digital Therapeuticsmentioning

confidence: 99%

“…By regulatory authority, most products are FDA cleared and CE marked. A total of 51 products received CE mark or FDA clearance, of which the number of CE marked products (26) was approximately double the number of FDA cleared products (14), and 14 products obtained both FDA clearances and CE marks. Most of the FDA cleared products obtained Class II grade certification, whereas most CE marked products were certified as Class I grade (Supplementary Table 2).…”

Section: Commercialization Of Digital Therapeuticsmentioning

confidence: 99%

“…However, researchers are suggesting the establishment of a regulatory system suitable for DTx. Researchers argue that the regulatory system of DTx is considerably vague 32 or insufficient 33 , and Vilardaga et al indicated the limitation that DTx regulation does not guarantee usability and continuous adoption 14 . A stakeholder study on the development of the DTx industry reported that it is important to develop guidelines for permits and prepare a simplified regulatory system following research funding, suggesting that the role of the government is important 34 .…”

Section: Regulation Of Digital Therapeuticsmentioning

confidence: 99%

See 1 more Smart Citation

Digital therapeutics from bench to bedside

2023

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As a new therapeutic technique based on digital technology, the commercialization and clinical application of digital therapeutics (DTx) are increasing, and the demand for expansion to new clinical fields is remarkably high. However, the use of DTx as a general medical component is still ambiguous, and this ambiguity may be owing to a lack of consensus on a definition, in addition to insufficiencies in research and development, clinical trials, standardization of regulatory frameworks, and technological maturity. In this study, we conduct an in-depth investigation and analysis of definitions, clinical trials, commercial products, and the regulatory status related to DTx using published literature, ClinicalTrials.gov, and web pages of regulatory and private organizations in several countries. Subsequently, we suggest the necessity and considerations for international agreements on the definition and characteristics of DTx, focusing on the commercialization characteristics. In addition, we discuss the status and considerations of clinical research, key technology factors, and the direction of regulatory developments. In conclusion, for the successful settlement of DTx, real-world evidence-based validation should be strengthened by establishing a cooperative system between researchers, manufacturers, and governments, and there should be effective technologies and regulatory systems for overcoming engagement barriers of DTx.

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Regulatory oversight of behavioral digital therapeutics for addiction treatment: A commentary on Khadjesari et al.

Cited by 4 publications

References 8 publications

THE CONCISE GUIDE TO PHARMACOLOGY 2021/22: G protein‐coupled receptors

THE CONCISE GUIDE TO PHARMACOLOGY 2021/22: G protein‐coupled receptors

The current evidence for substance use disorder apps

Digital therapeutics from bench to bedside

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