| Rising Need for Patient-Centered 'Decentralized Clinical Trials' Moving Away from Traditional Offline Environments
| Expansion of the DCT Market Driven by Establishment of Related Systems and Guidelines in the US, Europe, Sweden, Switzerland, etc.
| COVID-19 Pandemic Brought Changes Positioning DCTs as a New Clinical Trial Option
| Domestic Market Advances in line with Global Trends, Successful Validation Trials for Digital Therapeutics 'WELT-I' Using DCT, Spotlight on JNPMEDI's 'Maven DCT Suite'
The demand for patient-centered clinical trials conducted remotely, rather than traditional offline trials, is increasing significantly. The COVID-19 pandemic has accelerated this shift, making Decentralized Clinical Trials (DCTs) a prominent alternative, prompting regulatory discussions in various countries.
Denmark's medical regulatory agency released the world's first DCT guidelines in 2021, followed by the US FDA's guidelines in December of the same year. Subsequently, Europe, Sweden, Switzerland, China, and other countries have established systems and guidelines. These regulations enable participants to engage in clinical trials without visiting hospitals or medical institutions, rapidly expanding the DCT market globally.
■ Efforts to Establish DCT Foundations in South Korea: MFDS-MOHW Initiative for DCT Guidelines
With DCTs becoming an unstoppable trend, global regulatory agencies are racing to release relevant regulations, and global companies are quickly adopting DCTs. South Korea, currently ranked sixth in global clinical trials, is being urged to accelerate DCT adoption to solidify its position in the global market.
In response, the government is working on regulatory improvements and the formation of a DCT guidelines consultative body, with the Ministry of Health and Welfare (MOHW) leading the effort to establish DCT guidelines. The Ministry of Food and Drug Safety (MFDS) has also announced plans to focus on new technology support projects, with private companies expected to participate in the consultative body.
■ South Korea Showcases Global-Level DCT Capabilities with Significant Success Stories
As DCT becomes a cornerstone of clinical trials globally, South Korea is advancing with high-level technological solutions that stand shoulder to shoulder with global counterparts.
A notable example is JNPMEDI's 'Maven DCT Suite,' which has gained attention for its application in the validation trials for 'WELT-I,' the second domestic digital therapeutic approved by the MFDS. The Maven DCT Suite, developed by JNPMEDI, was used in the confirmation clinical trials for WELT's sleep disorder treatment software, demonstrating its effectiveness and safety.
The suite includes several components: ▲Maven eRecruitment for participant recruitment, ▲Maven Rscreening for screening participant eligibility, ▲Maven eConsent for obtaining electronic consent, and ▲Maven eCOA for collecting efficacy and safety data. These tools create a patient-centered clinical environment, significantly reducing the number of hospital visits and dropout rates compared to traditional offline clinical trials. Additionally, clinical data collected from participants and researchers is securely managed through the ▲Maven CDMS system, enhancing data accuracy and reliability.
The Maven DCT Suite offers higher efficiency by reducing both time and costs compared to traditional clinical trials. Its pay-as-you-go pricing model allows clients to select and pay for only the services they need, improving profitability. The solution’s blockchain technology ensures data integrity and reliability, making it a leading choice for next-generation clinical research.
■ Growing DCT Market Exceeds 10% Annual Growth, Solidifies Position as Global Trend
The COVID-19 pandemic brought significant changes to the clinical trials market and the entire healthcare-bio industry. According to the Bio Association, clinical research registrations decreased by about 70% at the beginning of the pandemic, with delays and suspensions. To overcome this, sponsors, including pharmaceutical companies and CROs, adopted DCT as a new option. Medi-Tech Insights projects the DCT market to grow from $8.8 billion in 2021 to $14.2 billion by 2026, with an annual growth rate exceeding 10%.
The advantages of adopting DCT are clear. Recruitment can be streamlined via websites or mobile apps, improving speed and participation rates. Patient-centered trials conducted irrespective of time and location can reduce time and costs, accelerating new drug development. Utilizing digital solutions for DCT can ensure high-quality data without modification or omission, enhancing drug development outcomes. Consequently, many countries, led by the US, are rapidly expanding DCT adoption.
A prime example is Moderna's COVID-19 vaccine development. Moderna used Medidata’s cloud-based solution to recruit 30,000 participants in 12 weeks for their mRNA-1273 vaccine trial in 2020, minimizing participant visits through remote data collection and completing product development efficiently.
| Rising Need for Patient-Centered 'Decentralized Clinical Trials' Moving Away from Traditional Offline Environments
| Expansion of the DCT Market Driven by Establishment of Related Systems and Guidelines in the US, Europe, Sweden, Switzerland, etc.
| COVID-19 Pandemic Brought Changes Positioning DCTs as a New Clinical Trial Option
| Domestic Market Advances in line with Global Trends, Successful Validation Trials for Digital Therapeutics 'WELT-I' Using DCT, Spotlight on JNPMEDI's 'Maven DCT Suite'
The demand for patient-centered clinical trials conducted remotely, rather than traditional offline trials, is increasing significantly. The COVID-19 pandemic has accelerated this shift, making Decentralized Clinical Trials (DCTs) a prominent alternative, prompting regulatory discussions in various countries.
Denmark's medical regulatory agency released the world's first DCT guidelines in 2021, followed by the US FDA's guidelines in December of the same year. Subsequently, Europe, Sweden, Switzerland, China, and other countries have established systems and guidelines. These regulations enable participants to engage in clinical trials without visiting hospitals or medical institutions, rapidly expanding the DCT market globally.
■ Efforts to Establish DCT Foundations in South Korea: MFDS-MOHW Initiative for DCT Guidelines
With DCTs becoming an unstoppable trend, global regulatory agencies are racing to release relevant regulations, and global companies are quickly adopting DCTs. South Korea, currently ranked sixth in global clinical trials, is being urged to accelerate DCT adoption to solidify its position in the global market.
In response, the government is working on regulatory improvements and the formation of a DCT guidelines consultative body, with the Ministry of Health and Welfare (MOHW) leading the effort to establish DCT guidelines. The Ministry of Food and Drug Safety (MFDS) has also announced plans to focus on new technology support projects, with private companies expected to participate in the consultative body.
■ South Korea Showcases Global-Level DCT Capabilities with Significant Success Stories
As DCT becomes a cornerstone of clinical trials globally, South Korea is advancing with high-level technological solutions that stand shoulder to shoulder with global counterparts.
A notable example is JNPMEDI's 'Maven DCT Suite,' which has gained attention for its application in the validation trials for 'WELT-I,' the second domestic digital therapeutic approved by the MFDS. The Maven DCT Suite, developed by JNPMEDI, was used in the confirmation clinical trials for WELT's sleep disorder treatment software, demonstrating its effectiveness and safety.
The suite includes several components: ▲Maven eRecruitment for participant recruitment, ▲Maven Rscreening for screening participant eligibility, ▲Maven eConsent for obtaining electronic consent, and ▲Maven eCOA for collecting efficacy and safety data. These tools create a patient-centered clinical environment, significantly reducing the number of hospital visits and dropout rates compared to traditional offline clinical trials. Additionally, clinical data collected from participants and researchers is securely managed through the ▲Maven CDMS system, enhancing data accuracy and reliability.
The Maven DCT Suite offers higher efficiency by reducing both time and costs compared to traditional clinical trials. Its pay-as-you-go pricing model allows clients to select and pay for only the services they need, improving profitability. The solution’s blockchain technology ensures data integrity and reliability, making it a leading choice for next-generation clinical research.
■ Growing DCT Market Exceeds 10% Annual Growth, Solidifies Position as Global Trend
The COVID-19 pandemic brought significant changes to the clinical trials market and the entire healthcare-bio industry. According to the Bio Association, clinical research registrations decreased by about 70% at the beginning of the pandemic, with delays and suspensions. To overcome this, sponsors, including pharmaceutical companies and CROs, adopted DCT as a new option. Medi-Tech Insights projects the DCT market to grow from $8.8 billion in 2021 to $14.2 billion by 2026, with an annual growth rate exceeding 10%.
The advantages of adopting DCT are clear. Recruitment can be streamlined via websites or mobile apps, improving speed and participation rates. Patient-centered trials conducted irrespective of time and location can reduce time and costs, accelerating new drug development. Utilizing digital solutions for DCT can ensure high-quality data without modification or omission, enhancing drug development outcomes. Consequently, many countries, led by the US, are rapidly expanding DCT adoption.
A prime example is Moderna's COVID-19 vaccine development. Moderna used Medidata’s cloud-based solution to recruit 30,000 participants in 12 weeks for their mRNA-1273 vaccine trial in 2020, minimizing participant visits through remote data collection and completing product development efficiently.