Decentralized clinical trials (DCT) drew attention by playing a central role in developing Covid-19 vaccines.

DCT is a new clinical trial technique attracting attention worldwide for its advantages compared to traditional clinical trials, such as easy patient recruitment, the convenience of conducting clinical trials, cost-effectiveness, data retention, and reduction of internal and external risks. However, its use in Korea is limited due to regulations, including those in the Medical Service Act.

Against this backdrop, “WELT-I,” a digital therapeutics (DTx) developed by WELT as a sleep disorder treatment software, has gained attention by winning approval using DCT. WELT used the DCT system of JNP MEDI, a medical data platform company, to conduct clinical trials to get the nod for WELT-I.

It was the first case of applying DCT to a medical product licensed in Korea.

Korea Biomedical Review met with Kim Hyung-joon, head of the business development team at JNP MEDI, to listen to the background for using its DCT solution in DTx clinical trial and the difficulties the company experienced in the process.

Question: Will you introduce JNMP MEDI to our readers?

Answer: JNP MEDI was founded to contribute to further developing Korea's internationally recognized healthcare infrastructure during the Covid-19 pandemic from the aspect of the medical data platform.

We have launched Maven Clinical Cloud, a clinical data management solution. We are collaborating with various stakeholders in the industry to collect, monitor, and analyze medical data based on digital technologies, including blockchain and cloud, and secure operational excellence across management processes. In addition, we recently conducted part of the clinical trial for insomnia DTx “WELT-I” using JNP MEDI’s DCT solution, Maven Suite.

Maven Suite is a clinical trial platform that maximizes time and cost efficiencies, enhances data integrity and reliability, and increases the accuracy of data analysis with a high hit rate by digitally transforming all aspects of clinical trials.

Q: What specific role did you play in conducting DTx clinical trials?

A: JNP MEDI has lowered access barriers to clinical trials and increased the participation rate of research subjects with Maven eRecruitment, an online subject recruitment solution. This has resulted in securing more diverse patient groups, significantly reducing recruitment time and saving time and money.

We also used our DCT platform to provide patient-centered clinical trial experiences, such as a screening process to determine participant eligibility (Maven Rscreening), electronic study documentation and consent collection (Maven eConsent), and clinical trial efficacy and safety data collection (Maven eCOA).

The result was a more than 50 percent reduction in the number of visits to medical institutions compared to the traditional face-to-face approach and a dramatic fall in the dropout rate.

In addition, by systematically managing the data collected from subjects and clinicians through the Clinical Data Management System (Maven CDMS), we provided the technology to preserve the important sensitive information of clinical data without missing any information and to perform accurate and reliable analysis.

Q: Tell us some memorable anecdotes while conducting DTx clinical trials.

A: I remember the process of creating eConsent. There were moments when things taken for granted in face-to-face trials became a challenge when we had to do it virtually. For example, we had to follow Good Clinical Practice (GCP) guidelines when collecting electronic clinical trial documentation and consent forms, which required multiple devices to verify that actual trial participants had read the documentation.

On the data side, we strengthened the system’s audit trail. On the patient side, we built a quiz during the transition from manual to consent form to prove that they understood the clinical explanations.

We designed it to be technologically adaptable by, for instance, allowing researchers to download and manage participants’ results as PDF files even after the trial.

Even with DTx, it’s impossible to go completely virtual due to regulations. However, many participants could do so without visiting hospitals each time, thanks to Maven Suite.

Q: Many call for continuous application of DCT, but the government remains cautious. What could be the reason as you see it?

A: A few years ago, banking on mobile was quite limited. But everyone is using it (mobile banking) now. So, if the government is a little more flexible in its perception, there will be a time when it will unwind DCT institutionally.

Q: How do you forecast the domestic DCT market?

A: I think the possibilities are endless. There are so many factors that can make DCT work well in Korea. Considering various factors, such as medical workers’ expertise, IT technology, and active clinical trials, the nation can introduce it comprehensively as much as we want in various areas, from anti-cancer drugs to medical devices.

The government has also vowed to develop the domestic pharmaceutical and biotechnology industry. To do so, new drug development is essential. Therefore, DCT, which improves the efficiency of clinical trials, is bound to receive the spotlight.

Of course, we have just taken the first step. First, however, I think it’s important to convey that it’s okay to keep walking, not how far you’ve walked, wearing good shoes.

Q: What are your goals?

A: The first goal is to become the undisputed number-one solution provider in the domestic clinical market in the short term. This requires experience in the domestic market. Ideally, we want to work hand-in-hand with many Korean companies to learn and grow and then go together globally.

It is important to grow quickly, but it is more important to learn from other companies and move forward correctly. That’s why our long-term goal is to learn from the best global practices and grow to a position where we can positively impact Korea’s clinical industry.