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 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 methodologies.
One benefit of decentralized clinical trials is the convenience and flexibility they offer to patients. Hybrid trials’ remote real-time data collection and monitoring minimize burdens for study participants. This balance helps with patient recruitment, as the goals of a clinical trial can be accomplished while asking less from 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 in clinical trial operations are a significant win for researchers.
Decentralized Clinical Trials Beyond the Pandemic
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 means to support 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 Trials
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 clinical trial sites. With decentralized or hybrid trials, sites must have robust quality assurance measures in place to ensure 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 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.