Decentralized clinical trials (DCT) are one of the latest clinical research innovations and are defined by Mckinsey as studies “centered around patient needs that improve the patient experience. The focus of such a trial is on making it more convenient, closer to the patients, or both by using a combination of virtual and physical elements to conduct the required trial procedures.”
The COVID-19 pandemic accelerated dramatically the adoption of DCT. In this context, many health regulators (FDA, EMA, MHRA,…) adopted urgent and temporary guidance to allow sponsors to adapt their current protocol and be able to conduct clinical trials remotely. But as time passes, all these regulators have realized that the use of “virtual elements” has grown in parallel with acceptance of “virtual medicine,” accelerating shifts in clinical trial design that many feel are long overdue. The shift has been reinforced by growing digital health technologies and also a rising interest in patient centricity from sponsors.
The following interview will give us an overview on the current DCT landscape and their importance, as well as an insight on the EvidentIQ Way.
Gilda: Why are DCT important?
Thomas: Because they help bring new treatments faster on the market and make it easier to reach demographics which would not have been thought attainable before. In a fully decentralized clinical trial, there is a minimum or even no need to go to a study center, which can accelerate the process and give more options on a pandemic, or not, context. Comparing to traditional clinical research, DCT will allow to speed up patient enrollment, increase patient retention and collect better quality of evidence thanks to remote data collection.
Gilda: How are DCT changing the clinical trial landscape?
Thomas: A few clinical trials were already using some virtual components before 2019. DCT have become a growing market since the COVID-19 pandemic. Recent first guidance published by health authorities are also encouraging a rising DCT adoption. In 2022, it is expected that there will be around 1,300 decentralized trials and/or with a virtual component. This will mean an increase of 28% compared to 2021. So, it is pretty clear that if you want to conduct a successful trial this year, DCT is your answer as it appears to be the new gold standard for the industry.
"In 2022, it is expected that there will be around 1,300 decentralized trials and/or with a virtual component."
Gilda: Which are the main benefits of DCT?
Thomas: There is a long list of DCT benefits, but in a nutshell, I think we can say that the first and most important is the easy access to patients wherever they live. You can conduct online patient recruitment and hence have faster patient enrollment, especially adapted for some specific diseases. This also helps to have better patient engagement and less drop-out as every step of the trial is easier for them, avoiding burden of onsite visits.
Aside from that we can also mention that DCTs have higher data quality for the sponsor, real-time monitoring, less source data verification, fewer intermediaries, a predefined and compliant format of data, among other things.
Benefits of DCT are "easy access to patients wherever they live. [...] better patient engagement [...] higher data quality for the sponsor..."
Gilda: Which are the challenges of conducting a DCT?
Thomas: Even though they are the future of clinical trials, there are still some issues that need to be perfected. Some conditions may prevent doing DCT even in hybrid mode, not all the population may have access to the necessary technology or might not be tech oriented. At the same time some of the exams might only be conducted at a hospital. And this is without talking about specific ethical or data privacy regulations.
Before starting a DCT, it’s key to be pragmatic here and ask the good questions to define the most adapted DCT strategy – hybrid of fully decentralized depending on virtual components to be selected.
However, despite this, DCT are worth the while and they are proving to be faster and more effective as time passes while bringing a great option to the table, a more diverse panel.
Gilda: Is it true that the costs of running a DCT are lower?
Thomas: Yes, it is, DTCs are a real game-changer, the time & costs to run a trial are substantially reduced thanks to the model. You only need to remember that every aspect of the trial needs to be thought through, so it can go smoothly and save you money.
"DTCs are a real game-changer, the time & costs to run a trial are substantially reduced thanks to the model."
Gilda: How is EvidentIQ a key player in DCT?
Thomas: At EvidentIQ we offer a direct access to patients with a global platform of 500k patients on 1,200+ conditions to design a patient centric DCT and speed up patient enrollment. We also combine best-in-class technologies and data sciences services to offer an innovative DCT experience. We have a Hybrid or 100% digital model with fully digital CRO services and innovative data sources to optimize your clinical research.
Gilda: Thanks a lot for your time.
For more information and a deeper understanding on this topic be sure to check out our upcoming webinar on this topic which will take place on March 10th at 5pm CET.