The pandemic was a clear catalyst in the rise of decentralized clinical trials (DCTs). But it may come as a surprise to some that this shift from traditional clinical trials was already gaining momentum in the years prior with advancements in technology.
Telemedicine platforms, electronic data capture systems, and wearable devices, among other innovations, provided an infrastructure to support decentralized clinical studies. Industry-wide analysis shows that many clinical trial sponsors want to take advantage of that remote infrastructure — often via hybrid clinical trials.
The Rise of Hybrid Clinical Trials in the COVID-19 Pandemic
In a 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 clinical trials, researchers can maintain in-person engagement for certain activities like assessments or lab tests; at the same time, they can benefit from decentralized trial elements.
One benefit of decentralized clinical trials is the convenience and flexibility they offer to patients. Hybrid trials' remote real-time data collection and continuous monitoring minimize travel burdens for clinical trial participants, allowing for more home-based assessments that prioritize comfort. This balance helps with patient recruitment, as the goals of a study can be accomplished while asking less from participants.
Meanwhile, with access to multiple engagement channels and flexible scheduling, 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 in clinical trial operations are a significant win for researchers.
Decentralized Clinical Trials Beyond the Pandemic: Expanding Patient Access & Improving Retention
While hybrid clinical trials have come into focus, there are still use cases for decentralized clinical trials beyond the pandemic.
Conducting clinical trials centered on rare diseases is one example. As Hassan Kadhim, Head of Clinical Trial Business Capabilities at Bristol Myers Squibb, noted in a 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 simplify patient recruitment by removing geographic barriers, allowing researchers to cast a wider net for participants.
Decentralized clinical trials can also be beneficial for studies with long-term treatment regimens as a means to support patient participation and compliance over extended periods. With the use of digital health technologies and remote data collection methods, virtual clinical trials can address protocol fatigue and make adherence more feasible.
Challenges With Tech-Enabled Clinical Research
Of the 73% of clinical trial sites that were approached about taking on a hybrid trial, 93% participated. The reason for this overwhelming participation rate was that clinical research facilities wanted to benefit participants and patients in their community.
While there's clear incentive for participation in decentralized and hybrid clinical trials, tech-enabled research studies still have their challenges.
If clinical research sites don't already have the technology infrastructure to support a decentralized or hybrid clinical trial, 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 traditional clinical trial sites. With decentralized or hybrid trials, sites must have robust quality assurance measures in place to ensure clinical trial data collected via digital tools is complete, accurate, and compliant with regulatory requirements.
Other challenges of these clinical investigations include having adequate staffing to support virtual 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 positions us as a leader in decentralized and hybrid clinical trials.
When a medical device trial was set to start amid the global pandemic, Remington-Davis (RDI) helped the sponsor and CRO quickly pivot from a traditional trial 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 this device trial on track, read our case study.
Frequently Asked Questions About Decentralized & Hybrid Clinical Trials
How should you decide between a decentralized and hybrid clinical trial design?
The decision should be driven by endpoint requirements, safety considerations, and the need for in-person assessments. Fully decentralized models work well when endpoints can be captured remotely, while hybrid designs are often preferable when imaging, lab work, or complex procedures require site visits.
How do decentralized and hybrid trials impact site selection?
Sites must demonstrate technology infrastructure, trained personnel, and experience managing remote workflows alongside traditional study conduct. Sponsors should evaluate a site’s ability to integrate vendors, maintain data integrity, and support participants across multiple engagement channels.
Do decentralized and hybrid trials improve enrollment timelines?
Yes, by reducing geographic and logistical barriers, these models expand the accessible patient pool. A broader reach can accelerate enrollment, particularly in competitive indications or rare disease studies where eligible participants are dispersed.
How do DCTs and hybrid trials support enrollment of underrepresented populations?
Remote visit options reduce transportation, work schedule, and childcare constraints that disproportionately affect underserved populations. When paired with intentional recruitment strategies, decentralized elements can meaningfully support diverse patient population objectives.
How do electronic patient-reported outcomes support decentralized and hybrid trials?
Electronic patient-reported outcomes (ePROs) allow participants to submit symptom data and quality-of-life measures remotely in alignment with trial protocols. When integrated with remote patient monitoring systems, ePRO tools enhance data continuity and support stronger patient retention.