Several current clinical trial models are outdated and cause issues for patients, trial sites, and sponsors such as subjects visit to the designated trial centre, site visits continue for regular follow-up, time constraints and there is a need for innovative clinical research solutions. With technological advancements, a shift has been observed in clinical trial activities closer to patients which improve patient and physician experiences. Decentralized clinical trials (DCTs) also termed as “direct-to-participant trials” or “virtual” studies use digital technologies and other processes that differ from traditional trial models to bring research closer to patients’ homes in order to increase access to trials, as well as reduce inconvenience and burden on participants by decreasing the number of physical site visits.
The Asia Pacific region, with its rapid growth of clinical trials presents a great opportunity for conducting clinical research and has become the preferred destination for DCTs. Factors driving adoption of DCTs in the region are large population, diverse ethnicities and geographies, treatment-naïve population, similar disease patterns, faster technology adoption and rapid growth of the pharmaceutical market.
In the period between 2017-2021, over 600 new DCTs were recorded in Australia, China, South Korea and Taiwan. Australia was the largest contributor with more than 55% of the DCTs, followed by China (35%), South Korea (22%) and Taiwan (12%). Across all countries of interest, DCTs were mostly used in Phase II and Phase III trials and its usage was significantly higher in industry sponsored trials over the last five years. Among all countries in the region, central nervous system diseases, metabolic disorders and infectious diseases were the leading therapy areas utilizing DCTs. Except for South Korea, mobile healthcare was the leading virtual technology utilizing DCTs in Australia, China and Taiwan.
Australia is quite established in terms of DCTs adoption compared to China, South Korea and Taiwan; few DCTs were reported prior to COVID-19 and during COVID-19. Overall, the adoption of DCTs is slow in these countries however, it is evolving, and it would bring a paradigm shift in clinical trials landscape. Top technologizes used in these countries are mobile healthcare, telemedicine, web-based technology, electronic data collection and mobile technology.