What is a Decentralized Clinical Trial and what advantages does it offer?
by Ana Díaz-Roncero, July 21, 2021
The pandemic has accelerated the implementation of many of the technological changes that have been under development over the past few years. Because of this, distance attendance at work or school no longer seems so strange to us. In the sphere of Digital Health, we have examples like medical applications, the use of QR codes for different healthcare processes, or telemedicine. This change has also come to research, with the funding of Decentralized Clinical Trials.
Decentralized Clinical Trials are different from traditional trials in that the participants do not have to come to the hospital, university, or research center where the study is being carried out. In this case, the participants receive the treatment at home, the monitoring and tests that might be necessary are carried out remotely, and the patients themselves incorporate data relevant to the trial through a series of questionnaires.
In 2011 one of the first decentralized clinical trials was carried out, replicating a previous clinical trial, but using a digital approach. Once finalized, no significant differences were observed in the result of that trial compared to the conventional trial. This began to show the viability of this type of study which, in addition to providing reliable results, would offer some additional advantages. What would these advantages be?
According to FDA Commissioner Dr. Scott Gottlieb, those trials are more agile and efficient. On one hand, they facilitate recruitment, which allows for more rapid implementation. On the other hand, as mentioned in the article, “Decentralized Clinical Trials: The Future of Medical Product Development?” they reduce costs for the researchers and sponsors by reducing the number of centers needed for the study, also improving the ability to react and make adjustments to the protocols.
From the patient’s point of view, the main advantage is the improvement in access. That could have an especially positive impact in studies focused on rare diseases because of the high geographic dispersion of the participants, according to Vallivana Rodrigo, researcher at the FISABIO Foundation.
In addition, this type of trial allows the patient to incorporate data from his or her daily life, in a real-life context (Real-World Data), enabling the generation of evidence that will help to improve the development of treatments and to adapt guidelines, including reducing the need to carry out post-approval safety studies, according to the FDA.
This is all possible today with the use of mobile applications, wearables, sensors, video calls and other devices that enable rapid and reliable distance monitoring. Many of those devices permit the collection of large amounts of information, both actively and passively, reducing data loss and facilitating the subsequent processing of the data.
One example of this is our patient platform, Caaring®, through which the patients can collect their health or quality of life data in a simple manner, facilitating remote monitoring and allowing healthcare professionals to receive the information in real time, improving their decision-making.
Ultimately, technology has a great deal to contribute to the execution of this type of trial, in which it is ever more important to use data from the patients themselves, remotely and in a real-life context.