While adoption of DCT technologies has increased in recent years, driven in part by restrictions imposed in response to COVID-19, the practice of shifting activities from sites to homes remains relatively novel. As such, the industry needs to build confidence and trust in DCTs to tackle organizational and individual risk aversion.
ACRO, a trade group that represents clinical research and technology companies, has responded to the need by creating a Q&A document that addresses the questions that stakeholders may have about DCTs.
“The industry has evolved to offer increasingly sophisticated tools and controls to help protect patient safety and safeguard data integrity in decentralized trials. Yet, expanded adoption of DCTs is impossible if stakeholders are not ready and comfortable in embracing this paradigm shift in clinical research. We hope it will help enable the kind of change management that is needed for stakeholders to embrace the use of DCTs,” said ACRO member Jim Streeter, global VP of life science customer success at Oracle.
Across 16 questions, the document provides information to address potential barriers to the use of DCT technologies, such as doubts about how the clinical trials protect patient safety and maintain principal investigator oversight.
In the document, ACRO argues that DCTs can enhance patient monitoring by gathering real-time data from wearables and other sensors and enabling investigators to collect information in tele-visits with the study participants.
The principal investigator is responsible for overseeing patient safety, as they are in traditional site-based clinical trials. As such, study teams need to consider how principal investigator oversight will work when patient interactions and assessments happen off-site.
In the guide, ACRO recommends having a detailed operational plan including a protocol outlining how to maintain oversight, clinical research associate processes to confirm tasks are completed, and triggers for tele-visits.