By Jingon Kim, Director, JNPMEDI
The global shift towards non-contact methods triggered by COVID-19 has significantly impacted many industries, including clinical trials. Decentralized Clinical Trials (DCT), where trial participants can consent, receive medication, and report side effects remotely from home or local healthcare facilities, have emerged as a prominent trend. A notable example is Moderna's DCT for their mRNA COVID-19 vaccine, which successfully recruited over 30,000 participants in just 12 weeks using a DCT solution and collected clinical data via smartphones.
Recently, DCT has become a recurring theme at global conferences and clinical research-related academic gatherings. Post-pandemic, the benefits of DCT—significantly reducing time and costs—are clear, prompting various initiatives by pharmaceutical companies, clinical trial centers, and Contract Research Organizations (CROs) abroad. While global pharmaceutical companies and CROs are actively pursuing the introduction of DCT in South Korea, domestic pharmaceutical companies and CROs remain skeptical. This difference in perspectives can be attributed to the contrasting regulatory cultures: Western countries often adopt a 'negative list' approach (allowing anything not expressly prohibited), whereas South Korea tends to permit only what is explicitly allowed.
Efforts to introduce DCT in South Korea exist, but the progress is slow. Since last year, the Ministry of Health and Welfare and the Korea National Enterprise for Clinical Trials (KoNECT) have been working on a one-stop smart clinical trial system to pilot DCT. However, the recent exclusion of DCT from the Ministry of Food and Drug Safety's 100 regulatory reform tasks has disappointed many industry stakeholders, who had advocated for South Korea to become a leading nation in clinical trials through the adoption of DCT.
In this context, JNPMEDI has made a groundbreaking attempt by conducting South Korea's first commercial-scale confirmatory clinical trial for insomnia digital therapeutic devices using DCT, rather than a pilot study or investigator-initiated trial. JNPMEDI's 'Maven DCT Suite' used in this trial allows for selective use of DCT elements, fostering diverse attempts in the nascent South Korean DCT market.
Shifting from hospital-centered to patient-centered clinical trials, DCT can improve perceptions of clinical trials and increase participant engagement, driving advancements in the domestic clinical trial industry. Efforts to promote DCT adoption and expansion continue through various related organizations, such as ARICTT's research on regulatory modernization in post-COVID clinical trial environments and KoNECT's clinical trial digital transformation research group. It is hoped that these efforts will soon bear fruit, positioning South Korea as a leading nation in advanced medical data and clinical trial innovation.
By Jingon Kim, Director, JNPMEDI
The global shift towards non-contact methods triggered by COVID-19 has significantly impacted many industries, including clinical trials. Decentralized Clinical Trials (DCT), where trial participants can consent, receive medication, and report side effects remotely from home or local healthcare facilities, have emerged as a prominent trend. A notable example is Moderna's DCT for their mRNA COVID-19 vaccine, which successfully recruited over 30,000 participants in just 12 weeks using a DCT solution and collected clinical data via smartphones.
Recently, DCT has become a recurring theme at global conferences and clinical research-related academic gatherings. Post-pandemic, the benefits of DCT—significantly reducing time and costs—are clear, prompting various initiatives by pharmaceutical companies, clinical trial centers, and Contract Research Organizations (CROs) abroad. While global pharmaceutical companies and CROs are actively pursuing the introduction of DCT in South Korea, domestic pharmaceutical companies and CROs remain skeptical. This difference in perspectives can be attributed to the contrasting regulatory cultures: Western countries often adopt a 'negative list' approach (allowing anything not expressly prohibited), whereas South Korea tends to permit only what is explicitly allowed.
Efforts to introduce DCT in South Korea exist, but the progress is slow. Since last year, the Ministry of Health and Welfare and the Korea National Enterprise for Clinical Trials (KoNECT) have been working on a one-stop smart clinical trial system to pilot DCT. However, the recent exclusion of DCT from the Ministry of Food and Drug Safety's 100 regulatory reform tasks has disappointed many industry stakeholders, who had advocated for South Korea to become a leading nation in clinical trials through the adoption of DCT.
In this context, JNPMEDI has made a groundbreaking attempt by conducting South Korea's first commercial-scale confirmatory clinical trial for insomnia digital therapeutic devices using DCT, rather than a pilot study or investigator-initiated trial. JNPMEDI's 'Maven DCT Suite' used in this trial allows for selective use of DCT elements, fostering diverse attempts in the nascent South Korean DCT market.
Shifting from hospital-centered to patient-centered clinical trials, DCT can improve perceptions of clinical trials and increase participant engagement, driving advancements in the domestic clinical trial industry. Efforts to promote DCT adoption and expansion continue through various related organizations, such as ARICTT's research on regulatory modernization in post-COVID clinical trial environments and KoNECT's clinical trial digital transformation research group. It is hoped that these efforts will soon bear fruit, positioning South Korea as a leading nation in advanced medical data and clinical trial innovation.