Many terms are used to describe decentralized clinical trials (DCTs) such as ‘virtual’, ‘remote’, ‘site-less’, and ‘hybrid’ but what is the exact definition? The FDA recently defined DCTs as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. They also clarified that DCTs should not be confused with virtual trials which are based on computer models and do not use real participants but computer programs to model participants to assess drug efficacy and safety during the preclinical phase.
This definition of DCTs allows for a variety of approaches to implementing DCTs.
- In a fully DCT, the study participant can participate in the entire clinical trial from their home or other convenient location. This means an electronic informed consent process would be utilized, investigational product would be shipped directly to the participant’s home, data would be captured directly from the participant via digital health technology, and samples could be collected at a conveniently located laboratory or via a home healthcare provider.
- A hybrid DCT includes elements of both a traditional clinical trial and decentralized trial and is the most common type of DCT currently being implemented. This allows flexibility for the participant while still maintaining subject safety and data integrity. For example, certain study designs may require participants to receive investigational product or specific procedures in a hospital setting. These trials would still require participants to come to a central investigational site for some study assessments.
The main benefit of DCTs is the participant-centric approach they take compared to traditional clinical trials. DCTs can expand the reach of traditional clinical sites by enrolling participants closer to where they live or work, can increase recruitment due to reduced barriers to trial participation, can increase participant diversity, collect additional data, and be conducted in a real-world setting.
Many different technologies are available today to communicate with and collect data from study participants remotely. The table below outlines some of the potential options teams can consider when developing their clinical trial. In a hybrid DCT an à la carte approach can be used to select which technologies are best suited for the trial design and target population.
· eCOA (Clinical Outcome Assessment) by the participant, clinician, observer/caregiver
· Web/Online Survey
· Devices (e.g., glucometers)
· Smart Watches
· Local Laboratory collections
· Telehealth visits
· Home healthcare visits
When considering all the different possibilities to decentralization during clinical trial development, it can be overwhelming to determine which aspects of decentralization to focus on, especially when there are several possible vendors providing solutions. A CRO like Rho can contribute to these conversations with a breadth of industry knowledge implementing decentralized trials across multiple Sponsors, therapeutic areas, vendors, and participant populations.
Heather Kopetskie, Director of Biostatistics, has over 16 years of experience in statistical planning, analysis, and reporting. She brings an extensive background of statistical and project leadership experience working on NIH and industry funded clinical trials in all phases of clinical development. Ms. Kopetskie has contributed to the publication of peer reviewed manuscripts and industry publications.