Decentralized Clinical Trials: Advancements in Technology and the Future of Clinical Research

Decentralized clinical trials (DCTs) have been in use for many years, but adoption of newer technologies has accelerated sharply during the COVID-19 pandemic. DCTs refer to clinical trials that enable a well-executed trial that meets the participant where they are emotionally, intellectually, and physically, according to Jeri Burr, Executive Director of the Utah Trial Innovation Center.

Advances in technology have allowed for the use of needle-free devices for remote clinical trial blood collection, such as the Hemolink device, which pulls blood from tiny capillaries in the skin under remote control. Additionally, electronic data capture (EDC) has replaced the use of paper in clinical trials, simplifying the collection and submission of information.

Remote clinical trials require the involvement of electronic data engineers, data scientists, and informaticists to validate data from devices that record electronic patient-reported outcomes (ePROs) and achieve data integration and harmonization. Cybersecurity experts are also necessary to mitigate threats from cyberattacks, such as malware and phishing schemes. Blockchain is being explored as a way to improve cybersecurity in DCTs.

DCTs challenge the status quo by offering a toolkit that can be used to simplify the collection of information and harness new technology that did not exist before. These tools enable the integration of large volumes of data in real-time, allowing for better tracking and monitoring of medical conditions. For example, instead of measuring A1C at intervals to track control of diabetes, real-time continuous glucose monitoring is now possible.

In conclusion, DCTs are not a new concept, but advancements in technology have made it possible to conduct clinical trials remotely, simplifying the collection and submission of data, and enabling the integration of large volumes of real-time data. As a result, DCTs are becoming increasingly popular, especially during the pandemic, and are likely to continue to evolve and improve.