People’s interest in decentralized clinical trials (DCTs) grew due to the Covid-19 pandemic as patients found it difficult to visit clinical trial sites.
However, a government report showed that Korea still ranked low in the proportion of DCTs out of all clinical trials.
Korea National Enterprise for Clinical Trials (KoNECT) released a report on the global clinical trial trends in 2022, saying a nation’s tendency to conduct DCTs was proportional to the regulatory institution’s preference for DCTs.
Globally, phase 3 DCTs were mostly about remote monitoring of blood pressure and blood sugar levels 10 years ago.
Recently, however, the size of phase 2 DCTs grew to the level of phase 3 studies, the report noted. This is because collecting digital data through sensors and wearable devices and remote monitoring have become widespread.
The pandemic drove up the growth of single-country DTCs. By country, the U.K. had the highest proportion of single-country DTCs with 12.8 percent, followed by Australia, New Zealand, Canada, and Denmark.
According to the report, the U.K. plans to expand the number of participants in a large-scale, contactless DCT, PANORAMIC (Platform Adaptive trial of NOvel antiviRals for eArly treatMent of COVID-19 In the Community), to 28,000.
As of Friday, 25,812 people expressed their intention to participate in PANORAMIC through 65 recruitment sites.
The report pointed out that traditional clinical trials were inefficient due to a low participation rate. In addition, the identification of trial participants, recruitment, data acquisition, and follow-up raise costs, increase participant burden, and prolong the trial period.
This leads to a wider gap in access among potential trial participants, limits the diversity of participants, and underrepresents important demographic groups, the KoNECT report said.
About 85 percent of the reviewed clinical trials did not report data on race or ethnicity. If a certain group is excluded because of difficulties in accessing the service, the clinical trial's external validity will be inevitably damaged, the report said.
The report also found that middle-income and East Asian countries had low proportions of DCTs.
Korea’s proportion of single-country and multinational DCTs in the past two years recorded 1.2 percent and 6.4 percent, respectively, which were the lowest among advanced nations, KoNECT said.
KoNECT Chairman Bae Byung-joon said, “We will form a task force for the digital transformation of clinical trials to collect industry opinions and find deregulatory measures, and contribute to enhancing the global competitiveness of Korean clinical trials and securing new drug development capabilities.”