Long Road Still Ahead For Decentralized Trials In Korea
Meeting Looks At Digital Tools, Hurdles
Executive Summary
At a recent conference in Seoul, experts urged South Korea to speed up the adoption of decentralized clinical trials and the adoption of digital tools in such studies as the country moves forward with its broader pharma development goals.
Although South Korea is a globally active site for clinical trials, currently ranked as the sixth most active country worldwide, it still appears to be far behind its peers in terms of adoption of decentralized studies and digital tools.
Korea has said it aims to become the fifth most active player globally by 2030 and plans to beef up its new drug development capabilities to achieve this. As of the end of 2021, it accounted for about 8% of the worldwide new drug pipeline, with just under 4% of all commercial trials taking place locally. The country aims to develop novel products oriented to its needs "as fast as possible" and to bring in global new drugs with the shortest possible time lag.
At a recent international conference in Seoul, Byoungjun Bae, president of the Korea National Enterprise for Clinical Trials (KoNECT), called for the need to bring in more innovative clinical trials, such as those that include adaptive design, and to increase decentralized clinical trials (DCT) through revision of laws or introduction of a regulation "sandbox."
Already being a major player in international trials, Korea is seen as having few technology barriers, but DCTs haven’t taken off because of various regulatory issues, Bae noted.
In addition, real-world evidence or real-world data should be used more extensively to expand indications for new drugs, and more experts trained to support capacity expansion. Through a public platform, the country needs to systematically support patients recruitment into trials and with studies taking place at dozens of centers at major university hospitals nationally, a one-stop, smart system needs to be established to link with KoNECT, he added.
KoNECT was set up in 2007 as a non-profit organization funded by Korea's Ministry of Health and Welfare to advance national clinical trial capabilities.
Lowest DCT Rates Among High-Income Countries
According to KoNECT, Korea had the lowest DCT rate among high-income countries for both single-country and multinational trials, reaching only 1.2% and 6.4%, respectively, over the past two years.
Largely because of the challenges posed by the COVID-19 pandemic, single-country DCTs have increased globally over the same time period. The UK ranked top in this category at 12.8%, followed by Australia (12.3%) and New Zealand (9.6%). For multinational DCTs, New Zealand ranked top with 11.3%, followed by the UK (11.1%) and Denmark (10.6%).
DCT rates were relatively lower among middle-income and East Asian countries. KoNECT noted that individual country trends have moved in parallel with each regulator’s preference for this type of study.
Lack Of Regulatory Framework
Meanwhile, the Korean market for "e-clinical" solutions (online tools related to clinical trials) stood at about $230m in 2021, accounting for 3.2% of the global total. But the domestic sector is expected to grow by an average of 16% per year to reach about $850m in 2030, accounting for 11.8% of the global market, KoNECT predicted.
Among e-clinical solutions, electronic clinical outcome assessments products have shown the highest growth, but so far such services have not been actively brought in from overseas largely because of language and cultural issues, the conference heard.
As in other industries, clinical trials are also riding a wave of digital transformation. But as regulatory frameworks related to e-clinical solutions and digital tools are still lacking, Korea needs to come up with appropriate policies that include technological and legal definitions to help the country move forward in the new era.
As part of these efforts, KoNECT established a research committee in June to speed up digital transformation in the sector. This comprises drug and health ministries, developers of COVID-19 vaccines and treatments as well as other relevant institutions.
KoNECT and the health ministry have also been pursuing a project to establish smart clinical trial platforms.
DCT-Related Activities
Eehwa Pae, senior clinical trial operations manager at Bristol Myers Squibb Company Korea, told the conference that discussions on DCTs are now underway in Korea, highlighting some ongoing initiatives in the country.
The discussions so far have included a definition of DCTs, including the elements of e-consent, telemedicine, home nursing, direct distribution of investigational drugs to patients, major issues in applications and legal considerations.
According to IQVIA, a survey of US respondents showed 94% of investigators would be interested in a study using a hybrid decentralized approach, with 71% agreeing that DCTs reduce the burdens on patients and 70% agreeing that DCT designs are more inclusive of patients who may not be able to participate otherwise.
Meanwhile, 80% of patients were found to be comfortable monitoring and reporting their symptoms via online tools and 82% were comfortable using mobile devices to do this.
During the discussion sessions at the KoNECT conference, sponsors raised various difficulties and issues in receiving e-consent from patients, the need to have proper guidelines to review and approve this, and how to identify the subject under a full remote consent situation.
Home nursing issues, which include the need for regulatory harmonization with DCTs, as well as possible data security issues in remote monitoring, were also flagged as areas for attention.
In a related move, a regulatory advancement working group in Korea is aiming to come up with specific guidelines for DCTs this year.