Growth Drivers for DCTs in the next 5 years
The global DCT market was estimated at $7.71 billion in 2022 and is expected to reach $18.29 billion by 2028. The key areas of focus to drive that growth will be:
The push to design adaptable, faster trial models:
The industry needs to access larger cohorts of patients that fit into required patient profiles for trials. More than 85% of trials fail to recruit the right patients on time, necessitating a hybrid approach, making it easier to access patients by conducting visits in the patient’s own community and through mobile / digital devices, significantly reducing cost burden.
Reducing challenges with the quality of data:
Sponsors continue to face data quality and data preservation challenges despite the growing acceptance and adoption of decentralized clinical trial models. While apps and devices capture ePROs (patient reported outcomes), they lack regulatory approval to be accepted as clinical-grade devices.
Planning for the regulatory variations impacting hybrid / decentralized (DCT) model uptake for multi-regional trials:
Although many regulatory agencies, global associates, and organizations, such as Decentralized Trial & Research Association (DTRA) and Association of Clinical Research Organization (ACRO) are working to guide the adoption and best practices of DCT implementation, emerging regions such as APAC lack this, adding to the complexities of designing a trial with a large global cohort and delivering a trial within this region.
Ensuring logistical and supply chain support:
Sponsors need to build strategic partnerships with global vendors to ensure a sound supply chain and distributor network. The hybrid trial and decentralized trial models rely on drug sourcing, coordination of supply, cold chain logistics, and documentation and regulations, it is critical that these processes have appropriate oversight and management.
Reducing skepticism and improving acceptance of change:
While the digital aspects of trials are a big newer, hybrid trials through at-home trial services have been around for almost 20 years, and both have established clear advantages for compressing trial timelines and overall cost of clinical trials. Even so, there is still a lot of work to be done by vendors and industry leaders to remove the skepticism around hybrid and DCT models.
Source: Frost & Sullivan, 2023
Author: MRN