The surge in the popularity of decentralized clinical trials might be chalked up to the COVID-19 pandemic. However, technological innovations making the transition from traditional to DCT possible will likely be in play after the pandemic has faded.
To learn more about the innovations associated with DCTs’ rise and how the future of the format might look, Outsourcing-Pharma connected with Isaac Rodriguez-Chavez, senior vice president of scientific and clinical affairs with ICON.
OSP: Do you think that we're headed toward a siteless study landscape?
IRC: At ICON plc, we actually provide the services for the end-to-end delivery of DCTs using digital medicine approaches. That goes from the design and the deployment of DCTs in the hybrid format as well as in the full format or model.
When it comes to our future and whether or not we are going to be siteless, or if studies will be siteless, from a regulatory standpoint and as a former senior FDA official, the regulations don't allow for clinical investigations to happen without the address of a clinical research site. There is a misconception of DCTs that have been siteless, and that is not permitted by regulation; it’s illegal.
If they were fully siteless, there would not be a physical site in which participants will go in to see in person: the investigator. However, there is an address. For the DCT side, which is the address and the affiliation of the investigator that is in charge of that density in charge of that decentralized clinical trial, the activities are conducted remotely, so you can look at this as a network in which all of these activities are happening as opposed to in a traditional investigation in which all of these activities are happening at that brick and mortar site with that specific address.
In both cases—in a DCT as well as in a traditional clinical investigation—there is a site. One is as a remote activity site and the other one is an in-person activity site, so DCTs really represent the permanent expansion of clinical research approaches that investigators and organizations have at their disposition to use when testing novel medical products.
In regard to the adoption and implementation of DCT approaches in the field, we'll continue steadily in the years to come, after calibrating the effect of COVID-19. Evidently, COVID-19 has catalyzed the implementation of the DCTs. The trends are in terms of the CAGR for DCTs and for multiple key sectors, so this is something that is clear to stay after that.
Post-COVID-19, DCTs will continue because the advantages are many and so post COVID-19, the focus will continue to be on participant-centric approaches to continue developing innovative ways to decrease the burden of the participants in the DCTs so that they can be attracted, they can be enrolled, and they can remain engaged in these clinical investigations.
The use of technology, then, is critical to lower the burden of the DCT participants and the optimization of efficiencies to capitalize on the effective use of resources and time to bring to market novel medical products in a shorter time and in a less costly fashion. Those are some of the value propositions of decentralized clinical trials.
OSP: Did you have anything that you wanted to add that you didn't touch upon earlier?
IRC: I would say the immediate trend on decentralized clinical trials enabled by technology is the unification of clinical research enterprise with the standard healthcare system in a concept that I called and that we call CRAACO—clinical research as a care option. That is really the immediate future of decentralized clinical trials and ICON is already offering that in the US. What we have right now is basic designs and approaches for decentralizing clinical research activities using technology.
Those models will continue evolving from just being DCT with technology, plus adding the key sectors that I mentioned such as digital therapeutics, enhancements in digital health technologies, wearables to measure novel digital endpoints in a holistic way as never done before, adding software as a medical device, and adding tokenization to understand the utilization of the standard healthcare system.
We have to look at DCTs from a holistic standpoint, not only from the basic designs and the deployment of DCTs under the current approaches and models, but from the ‘metaverse’ viewpoint, which is applied to the digital knowledge across the entire human knowledge in multiple fields, so these are dimensions of complexities in which decentralized clinical trials are included, and the largest of all really is the metaverse and the metaverse really right now is used in medicine, because the metaverse is a 3D network in the digital world where users may interact and experience virtual reality as the real world, and this involves an augmented reality life of a mirror world virtual reality more in our biomedical and clinical research field and in a concentric circle.
The next, internal concentric circle is what I call the digiverse. This is the innovative universe of digital technology options that are used for unique and customized support of modern trial approaches such as decentralized clinical trials.
The next concentric dimension is the utilization of DCTs with CRAACO, and digital therapeutics, for example, to offer participants access to the standard healthcare system and tools, digital tools to modify behaviors and enhance health outcomes. That's digital therapeutics. And those are three interventions or three digital connected spaces, or applications in one concentric complexity in the application of DCTs.
Internally, another dimension within the space is called the duplex digital units, in which we can use DCTs and CRAACO, or DCTs and tokenization. The most internal one is the single digital unit, which is just one DCT, as we're doing right now with technology. The core of all of these is the technology ecosystem that is representing the digital hallmark of each decentralized clinical trial.
This is a long-winded answer to say there is a trend that is enabled by technology that is going in sync with new technological developments, creating decentralized clinical trials as a breach to add multiple components in digital medicine that will help to do the holistic assessment of new medical products and assess safety and efficacy in a remote fashion, in an efficient fashion.
Offering this to participants and in a collaborative, unprecedented collaborative partnership among multiple organizations, and we will see more of these complex dissect models as we evolve with technology in the years to come. This is something that we're doing. At ICON plc, we're already implementing all of these digital medicine components and using the technology to make our quality of life significantly better.