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INNOSC Theranostics and
Pharmacological Sciences Digital therapeutics for obesity management

Table 2. Differences between conventional pharmacotherapy and digital therapeutics 7
Category Pharmaceutical Digital therapeutics
Development cost Very high cost (about $1.8B) Comparatively low cost
Development period Approximately more than 10 years Approximately<10 years
Manufacturing Continuous production required through manufacturing No additional manufacturing is required after initial
facilities development
Phases of clinical trials Human pharmacology study (Phase 1) Exploratory study (Pilot, optional)
Exploratory study (Phase 2) Confirmatory study (Pivotal)
Confirmatory study (Phase 3)
Regulation Pharmaceutical law applicable Medical device law applicable
Medication monitoring Manual monitoring done Real-time automatic monitoring done
Medication adherence 50% 80%
Prerequisites Not required Digital device, appropriate level of cognitive ability needed
Prescription Mandatory (ETC only) Mandatory (PDTs only)
Data security Not applicable Need cyber security and data protection solutions
Abbreviations: ETC: Essential-therapeutic-category; PDT: Prescription digital therapeutic.

Figure 3. The workflow of digital therapeutics used in obesity management. Image created by author.
Abbreviation: RCTs: Randomized controlled trials.

and eating patterns, it is recommended to address multiple for FDA approval. While many studies have investigated
domains including behavioral, cognitive, emotional, digital interventions for weight loss, not all have been
motivational, and anthropometric aspects. Since behavior structured as RCTs. To conclusively demonstrate the
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styles and engagement with DTx are greatly influenced effectiveness of new DTx, RCTs are essential. One of the
by cognitive structuring and emotional regulation, an most critical and challenging aspects of designing RCTs
integrated clinical approach that incorporates all these for DTx is creating an appropriate control group. Digital
elements is essential for effectively addressing obesity- interventions encompass a wide range of features, such as self-
related challenges. monitoring, cognitive-behavioral therapy, user interface/
user experience, and human coaching. This diversity makes
3.3.1.2. Efficacy of DTx in RCTs
it difficult to determine which specific features are effective
The goal of RCTs is to evaluate the effectiveness of new and which should be compared in the trials. Selecting
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treatments while reducing potential biases, such as the the primary active ingredient of DTx and creating a
placebo effect. During the RCTs, both the efficacy and safety specific active sham control group (an identical DTx
of treatments are established, which are critical factors platform without the primary active ingredient) presents

Volume 7 Issue 4 (2024) 5 doi: 10.36922/itps.4042