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[Digital therapeutics: Which barriers for market access?]
A Rochereau1, C Dorphin2, N Martelli3
1Université Paris-Saclay, GRADES, 5, rue Jean-Baptiste-Clément, 92290 Châtenay-Malabry, France.
Annales Pharmaceutiques Francaises
|December 13, 2021
Summary
Digital therapeutics (software for disease prevention, treatment, or monitoring) show promise in patient empowerment but face challenges in clinical validation and funding due to unclear definitions and trial suitability.
Area of Science:
- Digital health innovations
- e-health technologies
- Software as a Medical Device (SaMD)
Context:
- Digital therapeutics (DTx) are software-based interventions integrated into e-health.
- DTx aim for disease prevention, treatment, and monitoring with a defined mechanism of action.
- Strong clinical evidence underpins the efficacy of DTx.
Purpose:
- To evaluate the clinical validation level of digital therapeutics.
- To analyze the business models associated with digital therapeutics.
- To explore perspectives on DTx assessment and market viability.
Summary:
- Qualitative study involving 22 interviews with health actors identified key themes in DTx.
- DTx are recognized for their role in patient follow-up, prevention, and empowerment.
- Challenges include definitional ambiguity, heterogeneity, and clinical trial suitability.
Impact:
- Study findings offer new perspectives on DTx assessment and business models.
- Highlights the need for adapted clinical trial methodologies for DTx.
- Suggests DTx represent a new form of healthcare innovation and system organization.
Keywords:
Accès au marchéClinical and medico-economic assessmentClinical trialDigital therapeuticE-healthE-santéEssai cliniqueMarket access evaluationThérapie digitaleÉvaluation clinique et médico-économiqueMore Related Videos
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