What are Decentralized Clinical Trials?

The discussion around decentralized clinical trials (DCTs) has intensified in recent years, partly due to the advancement of technology. This post will shed light on what decentralized clinical trials are and what they entail. We’ll also illuminate some of their benefits and the challenges you’re likely to face when using them. Keep reading to find out more regarding the application of decentralized trials in the clinical research industry.

What are Decentralized Clinical Trials?

A decentralized clinical trial is a clinical trial concept that makes it more convenient for patients by removing or reducing the need for patients to travel to particular locations. DCTs have helped enhance research effectiveness, minimize drop=out rates, and generally get life-saving treatments to the market faster.

Decentralization doesn’t mean performing clinical trials in the absence of medical professionals, and neither does it mean removing the need for physical patient contact. Instead, it means assessing the aspects where technology and upcoming solutions can allow CROs and sponsors to integrate a hybrid approach to clinical trial design. Decentralization offers an alternative to inflexible, site-anchored systems, which frequently lead to high rates of patient dropouts.

Decentralized clinical trials usually exist on a spectrum. Suppose planning for a decentralized design where patients don’t have to set foot in a clinical facility isn’t possible. In that case, it doesn’t mean your research can’t benefit from integrating some at-home or virtual elements. For instance, site visits can be substituted with an HCP making home visits to the specific patients or with a mobile application that allows data collection without the need for patients to attend physical appointments.

With the rapid advancements in technology and as more clinical trials successfully incorporate decentralized elements, the number of home-based clinical trials and participants will also increase.

Key Benefits of Decentralized Clinical Trials

Hybrid (a blend of home-based and site activities) and fully decentralized clinical trials can positively affect clinical trial development processes in various ways, including:

It improves patient experience

Decentralized clinical trials provide a more patient-oriented approach by supporting patients to engage in clinical trials from the comfort of their homes. This design allows people to spend more time with their families, concentrate on their main tasks, and not commit their regular lives to being stuck in clinical facilities.

In addition, DCTs come in handy for patients experiencing mobility problems or those who want to live near a clinical trial location.

It reduces the need for travel

Based on research by CISCRP involving 12,450 patients, most of them reported travel time (distance and geography to the clinical location) to a medical facility as the major hurdle affecting their participation, especially young people.

Decentralization offers more convenience for participation. Patients in various countries globally can access treatments despite their location.

It doesn’t significantly disrupt your daily life

Although participation in clinical trials offers patients hope and access to a new, effective therapy, it also takes plenty from their personal lives. To complete all site visits, patients can skip work for multiple hours, leave their home and children, or even depend on a family member to take them to and from the hospital visits.

DCTs simplify patients’ lives by allowing them to remain home when being screened or treated.

It enhances precision

When researchers access a wider population through a massive geographical footprint, it allows them to see the bigger picture and assess the novel treatment that will impact various patient groups.

Using mobile technology, DCTs can collect an enormous quantity of data than what can be collected in traditional clinical studies. In turn, DCTs offer data that is near the real-world setting, free from visit length and frequency.

Challenges Facing Decentralized Clinical Trials

When shifting to DCTs, here are several challenges you’re likely to encounter.

• Although some regulatory agencies support innovative clinical trial designs, several compliance guidelines are lacking
• Qualifying technologies before their application – to ensure quality, safety, and compliance
• The learning curve for patients, caregivers, sites, and project teams
• The need to formulate internal quality management systems, such as training sessions, policies, and standards of procedures (SOPs)