The Coronavirus disease 2019 (COVID-19) pandemic has led to many changes in the way different processes are handled. In particular, it is profoundly disrupting clinical research. Many start-up activities for new clinical trials may be deferred and recruitment suspended. However, the COVID-19 pandemic also creates opportunities for innovative trial designs. There have been new proposals and options for performing clinical trials, which take advantage of modern technologies.
One such technology was called a Decentralized Clinical Trial (DCT).(1) Some different phrases are used when discussing DCTs, for instance, “remote,” “virtual,” “direct-to-patient,” “site-less,” and “hub-and-spoke” clinical trials. For the purposes of common terminology, the term ‘decentralized clinical trials (DCTs)’ are accepted in general.
DCTs allow the development of tasks that traditionally could only be done face-fo-face to be done remotely and involve new technologies through telemedicine, mobile, or local providers,(1) that are more efficient and cost-effective.(2) Furthermore, These technologies offer an opportunity to collect novel forms of data in real-world environments, offering the potential to improve the reliability, generalizability, and applicability of research findings.(3)
Decentralized clinical trial models can have a variety of advantages for patients. The key benefits of DCTs include, but not limited to easy and faster trial participant recruitment, improved trial participant retention, increased participant diversity, reduction on patient burden, better control and comfort for participants, improve data quality, patient experience and improved clinical trial continuity. Additional benefits may be to improve the generalizability or external validity of the evidence obtained from clinical trials, without significant sacrifices in internal validity.
DCTs have been gaining impetus for several years, supported by mobile technologies and novel innovations. The US Food and Drug Administration (FDA) has promoted the DCT as an alternative to traditional trials, which did not appear with the pandemic, but rather have been gaining traction for the lasts few years, as more and more technologies have made them more approachable and realistic. Many proponents also have been in favor, because it would allow more people to take part in the trials, improving the results.(4)
However, DCTs have not been adopted very quickly. Some biological pharma companies have done pilot studies, but have not decided to take them on as an equivalent to traditional trials. There is limited knowledge about best practices, awareness, and general willingness to work on DCTs, which have been the key obstacles, as per the organizations working to increase their adoption.(4)
Why are DCTs needed? Studies indicated that with the traditional clinical trial model, 85% of trials do not recruit enough participants and 80% do not finish on time. 70% of potential participants live more than 2 hours away from their nearest study center which limits recruitment and retention. 20% are canceled due to enrollment problems. DCTs could help reduce this set of problems. The benefits they offer could make the trials less difficult for patients. (5)
Furthermore, DCT improves the patient´s experience, by demanding less time and allowing them to focus on their responsibilities and relationships, so they can be at home. This can also allow patients who mobility issues or those with significant issues, such as fatigue. It significantly reduces the traveling burden, which is suggested to be a significant barrier for up to 60% of trial participants. People would be able to access treatment from rural areas, other cities, and even other countries without significant financial costs. By reducing these barriers, retention and recruitment rates are also likely to improve. (5)
Regarding this point, FDA also recommended virtual assessment when possible in its guidance for conducting clinical trials during the pandemic (6) and started to work on supporting and promoting virtual trials. The COVID-19 pandemic has highlighted the need for more remote access and greater technology use. There have been studying results ...
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