The Road Ahead for Decentralized Clinical Trials

The pandemic was a clear catalyst for the rise of decentralized clinical trials (DCTs). But it may come as a surprise to some that this shift was already gaining momentum in the years prior due to advancements in technology. 

Telemedicine platforms, electronic data capture systems, and remote monitoring tools, among other innovations, provided an infrastructure to support decentralized trials. Industry-wide analysis shows that many clinical researchers want to take advantage of that remote infrastructure — often via hybrid decentralized clinical trials.

Leveraging the Benefits of DCTs Through Hybrid Approaches

In a 2023 technology survey from the Society for Clinical Research Sites, as many as 73% of clinical trial sites reported that a sponsor or CRO approached them to conduct a hybrid-type trial. 

With hybrid DCTs, researchers can maintain in-person engagement for certain activities like assessments or lab tests — at the same time, they can benefit from decentralized trial methodologies.

One of the benefits of decentralized clinical trials is the convenience and flexibility they offer to patients. Hybrid trials maintain this benefit through remote data collection and monitoring that minimizes burdens for study participants. 

Meanwhile, with access to multiple engagement channels, study participants are more likely to stay engaged in their respective trials. Considering the average cost to recruit one clinical trial patient is $6,533, higher retention rates are a significant win for clinical researchers.

Decentralized Clinical Trials Beyond the Pandemic

While hybrid decentralized clinical trials have become a key focus, there are still plenty of use cases for DCTs beyond the pandemic.

Clinical trials centered on rare diseases are one example. As Hassan Kadhim, Head of Clinical Trial Business Capabilities at Bristol Myers Squibb, noted in a recent PharmaVoice article: “Recruitment is definitely a challenge for rare diseases, because there are so many patients in the world that are affected by a specific condition and you need to find them and you need to make it easier for them to participate in a trial.”

Decentralized clinical trials can also be beneficial for studies with long-term treatment regimens as means to support participation and compliance over an extended period.

Challenges With Tech-Enabled Clinical Trials

Of the 73% of clinical trial sites that were approached about taking on a hybrid trial, 93% participated. The overarching reason for this overwhelming participation rate was because sites wanted to benefit participants and patients in their community.

While there’s clear incentive for participation, tech-enabled trials have their challenges. 

If sites don’t already have the technology infrastructure to support decentralized or hybrid trials, they can wind up spending a lot of time on training and managing tech vendors each month. In fact, 40% of clinical trial sites reported spending five to 15 hours on monthly training for trials with remote technology. This takes away time otherwise spent engaging patients.

Data quality, meanwhile, has long been tethered to on-site monitoring across trial sites. With decentralized or hybrid trials, sites must have robust quality assurance measures in place to ensure collected data is complete, accurate, and compliant with regulatory requirements.

Other challenges include having adequate staffing to support remote trial operations, from shipping study materials, to conducting remote monitoring, to dropping off items to patients.

Remington-Davis Is a Leader in On-Site & Remote Clinical Trials

While supporting on-site trials at our 5,000 square-foot facility in Columbus, Ohio, our trail-blazing work with remote clinical trials has positioned us as a leader in decentralized trials.

When a medical device trial was set to start amid the global pandemic, Remington-Davis (RDI) helped the sponsor and CRO quickly and seamlessly pivot to a decentralized clinical trial design. In the words of Brandy Chittester, the CRO’s then-president: “With RDI’s support, we were able to run a fully remote study before it was common and get the trial done on time.”

To learn more about how we helped keep the device trial on track, see the case study.