At the beginning of the 21st century, the life sciences industry introduced the decentralized clinical trial model. What is a decentralized clinical trial, and what are the benefits for participants, investigators, and clinical trial sponsors?
What is a Decentralized Clinical Trial?
Firstly, what is a decentralized clinical trial, and how does this differ from the traditional clinical trial model? In brief, a decentralized clinical trial is a clinical trial that primarily relies upon digital methods of data collection or digital methods of oversight.
What are the key elements of Decentralized Trials?
The most distinctive element of the decentralized clinical trial model is that it uses fully electronic methods of data capture and communication. In other words, all trial procedures are conducted remotely, using a range of digital technologies.
This is markedly different from the traditional fully-centralized trial model, where all aspects of a trial, ranging from enrolment to data collection, are conducted at a research site, such as a university, or a hospital. A decentralized clinical trial model is also different from hybrid trials since hybrid trials still require some aspects of trial participation (for example, the completion of consent forms, or the collection of blood samples) to be conducted at a research site in person.
From a data collection point of view, this means that many elements of the traditional physical (paper-and-pencil) forms of data collection are completely replaced by electronic methods of remote monitoring. A particularly attractive element of this trial model is that traditionally, trial participants have been required to attend clinical trial sites in person.
The decentralized clinical trial model does away with this requirement since this model means that all aspects of the trial can be delivered remotely. Indeed, most trials that use this model can be conducted entirely in the homes of trial participants.
Additionally, the use of digital tools such as video conferencing can also be used to simplify the trial enrolment stage. From a sponsor perspective, decentralized clinical trials allow for the simultaneous electronic monitoring of multiple trials, since all trial documentation is electronically stored and made available.
This replaces the traditional requirement for sponsors to physically attend each site, meet with investigators and inspect paper-and-pencil case report files.
What are the potential benefits of using Decentralized Clinical Trials?
The decentralized clinical trial model has a number of advantages compared to the traditional face-to-face clinical trial model. This is apparent from the perspective of clinical trial participants, investigators, and sponsors.
First and foremost, the main benefit of using a decentralized clinical trial model is that trial participants can quite literally take part from any location, across the world. The decentralized clinical trial model is also highly-attractive from a trial investigator’s point of view, since the level of burden placed upon them in terms of trial enrolment, and data capture, is dramatically reduced.
This is attractive from a patient experience point of view. Although the decentralized clinical trial model has been around since the early 21st century, it is arguably the ongoing COVID-19 that highlighted the benefits of this model for investigators, sponsors, and clinical development.
Specifically, the increasing use of decentralized trials during this period allowed a number of pharmaceutical companies to continue data collection and product development, when other face-to-face studies had to be paused, or in the last scenarios, canceled completely. From the perspective of clinical trial participants, the burden is reduced.
What are the potential downsides of using Decentralized Clinical Trials?
There are potential limitations to virtual trials, which investigators and sponsors should be aware of. For this reason, proper care needs to be taken to ensure that decentraliztrials result in a reliable level of data quality when they are used for data collection.
For instance, the technology underpinning clinical research tools has to ensure that participant data will not be lost. Additionally, investigators and sponsors also need to be aware of the potential for adverse events and need to have robust reporting and safety protocols in place, in all trials.
Therefore, this model may not be appropriate for trials of high-risk medicinal products. However, many of these issues have now been addressed. Overall, decentralized clinical trials are exceptionally promising, and should be considered for all future clinical studies.
Simon Gregory, a seasoned Raspberry Pi enthusiast and IoT innovator, brings a wealth of knowledge to Pi Beginners. With a background in computer science and a passion for teaching, Simon simplifies complex concepts, making Raspberry Pi accessible to all. His articles not only guide but inspire readers to explore the limitless possibilities of Raspberry Pi in the IoT realm.
