Development of 'Maven DTx Suite', a clinical trial support service for digital therapeutics

Amid the spread of non-face-to-face medical practices due to the risk of infection caused by COVID-19, demand for digital therapeutics (DTx) is also increasing. The digital therapy approach, which enables remote diagnosis and prescription through patient real-time monitoring and extended information, is emerging as a new opportunity for medical innovation, as the amount of interchangeable information such as patient hospital visits and doctors' diagnosis and prescription is limited.

Digital treatments are medical devices, not drugs, but are classified as third-generation treatments following first-generation treatments (low molecular compounds such as pills) and second-generation treatments (biological sanctions such as antibodies, proteins, and cells) because they provide disease treatment functions like existing drugs using software.

Although it is a new type of treatment, it requires clinical trials, verification of treatment effects, and permission from regulators, as well as doctor prescriptions and insurance coverage, just like existing drugs.

Since digital therapeutics are classified as medical devices, there is no preclinical stage, and clinical trials for humans only need to pass two stages: exploratory clinical trials equivalent to Phase 1 and Phase 2 and confirmatory clinical trials equivalent to Phase 3. Compared to existing drug clinical trials, the short trial period and low cost are also one of the advantages of digital treatments.

Last year, the FDA reportedly approved a total of 20 types of digital treatments. Amid active research and development of digital treatments in Korea, some companies have begun confirmation clinical trials, the last gateway, and it is highly likely that the first digital treatment approved by the Ministry of Food and Drug Safety will be born within this year.

However, most companies in the early stages of development have suffered a lot due to the lack of specialized institutions for clinical trials of digital treatments and the lack of specialized guidelines. Among them, there are domestic companies that are providing professional support services for the development of digital treatments.

JNPMEDI, a medical data platform company, is accelerating the development of "Maven DTx Suite," a clinical trial support service for companies developing digital treatments.

Maven DTx Suite

From the perspective of the entire life cycle, from development to follow-up management, what kind of service support is needed through specialized institutions, and the strategy of the "Maven DTx Suite" service presented by JNPMEDI is as follows.

Development Phase: There is no single methodology applied to digital therapy, but so far, methods based on cognitive behavior therapy (CBT) are often used to stimulate patients to change their lifestyle. Developing software algorithms that match evidence-based therapeutic intervention and providing services based on PaaS (a form of service that provides a development environment and process) can speed the development of digital treatments of similar characteristics.

Validation stage: Digital therapy is provided in the form of SaMD (Software as a Medical Device), so unlike hardware, defects occur without warning in advance. Therefore, a documented development process based on CSV (Computer System Validation) should be combined to check and verify that the software runs perfectly and accurately and that the output information is integrity. Furthermore, to enter the overseas market, it is necessary to establish a quality management system related to medical device safety (ISO 13485) and medical information protection (ISO 27799).

Clinical Trial Phase: Digital Therapeutics are now in its infancy and are experiencing many difficulties from the design phase of clinical research due to insufficient references. Pharmaceutical companies and CROs (clinical trial consignment agencies) familiar with existing clinical trial methods need clinical trial methodologies and data management that suit the characteristics of digital treatments. Due to the nature of digital treatments, prescription management and monitoring are inevitably carried out remotely, so the application of technologies related to Decentralized Clinical Trials will be an essential requirement.

Commercialization Phase: Challenges Still Remain After Digital Therapy Approval. It is necessary to think about how to prescribe and distribute digital treatments. Under the premise that the doctor's change of perception of DCT, which is the subject of prescription, should be resolved, a distribution design in terms of digital literacy should be made so that digital treatments can be purchased, downloaded, and used easily on the Internet. In the case of chronic diseases such as diabetes and high blood pressure, it is necessary to keep in mind the use of the elderly.

Post-marketing management stage: Security devices should be in place to prevent personal information leakage due to digital characteristics, along with safety monitoring of patients currently being treated. Quality management should be carried out continuously to prevent changes in safety and effectiveness at the time of initial approval, and system-side support such as software change and version management is essential, considering the changeable characteristics of existing drugs.

JNPMEDI is currently conducting clinical research with domestic digital treatment development companies using step-by-step service strategies and plans to develop Maven DTx Suite services through related government projects planned in the future.