Harnessing technology standard in other highly regulated industries, decentralized clinical trials (DCTs) are gaining traction and becoming a more significant part of our industry. They’re not a panacea for clinical research obstacles or always an option. Still, from both patient-centric and business return on investment (ROI) perspectives, they shouldn’t be ignored.
We understand the trepidation many feel when it comes to adopting new technology in clinical trials. Lives are at stake, and expediting regulatory approval is vital to serving populations in need. But that’s the point: patient issues rank among the top 3 research obstacles. Most trials have long delays and spend enormous amounts of money due to participant recruitment and retention issues. Change is necessary.
At Medrio, we’re looking at how new tech can allow patients to participate more comfortably in clinical trials. We’re contributing to the decentralized trial movement by supporting researchers with our closed-loop EDC-eSource system. Last year we sponsored the first-ever decentralized trials conference. This year, we expect more hybrid and virtual pilot programs than ever before.
We want to give you essential insight into what decentralized clinical trials are, why they have enormous value for research teams, and how you don’t have to go entirely virtual to streamline research and be more patient-centric. We’ll also share useful information on logistics, and what types of trials make the best pilots.
Decentralized Clinical Trial Definitions
Decentralized clinical trials (DCTs) include models with various names: direct-to-patient, remote, site-less, hybrid, and virtual clinical research. Like with many new technologies, the industry is figuring out the best language to describe these frameworks. However, they all boil down to 2 core modalities:
Direct-to-patient or remote: Data is collected in the patient’s home or in an environment that’s convenient for the study participant. Some also use the term “site-less” to refer to these types of trials.
Hybrid: Combine the use of both sites and remote locations. They aim to maximize patient-centricity by giving participants more flexibility in how they participate in the trial.
What do they both have in common? They use digital tools to decrease reliance on physical locations and intermediaries. They aim to facilitate patient comfort and help research teams make better-informed decisions about new treatment efficacy.
We want to highlight it’s not all or nothing when it comes to decentralized trails. It’s possible to integrate decentralized elements into a protocol to enhance patient engagement and facilitate data collection without going fully virtual. Even in trials where patients need to make site visits for CTs or MRIs, perhaps it’s still possible to use new technology to reduce patient burden and streamline the research process in other ways.
The FDA’s view of decentralized clinical research
In 2019, the FDA expressed support for the shift to decentralized research. European and Asian regulators have all highlighted their value. But why?
- These models facilitate recruiting, enrolling, and retaining participants – a costly challenge faced by most research teams.
- They reduce administrative burdens on sponsors and investigators. At the same time, they improve study quality and data integrity and allow patients to receive treatments more comfortably.
- More frequent, sensitive, and objective measures from digital tech help teams answer research questions faster and cheaper. They also facilitate regulatory approval.
How to use decentralized trials for study design optimization
With decentralized research, there is a lot of low-hanging fruit for increasing patient-centricity and streamlining research. Still, even with regulators signaling their support, a lack of supporting culture to change is often cited as the most significant adoption hurdle. While decentralized models will not work for all types of research, in many cases, there is so much to gain by making simple changes to trial design. Here is a framework to help:
- Use decentralized trials as one component of study design optimization. Keep in mind a trial does not have to be fully virtual to have a significant impact on patient centricity. Also, not all trials can be decentralized.
- Dig into each aspect of your research process and evaluate how technology can streamline workflows. Perhaps several decentralized elements could support your team’s efforts. A cost-benefit analysis can help you to gain crucial insights.
- When designing your protocol, ensure that tech doesn’t unnecessarily drive up costs. The goal of new technology is to help, not hinder.
- If technology significantly reduces patient burden, you may still want to consider it. Over the course of the trial, it will likely lessen the overall cost. For example, in research where participants have limited mobility, even if certain tech is more costly upfront, enabling televisits could vastly reduce patient burden and accelerate timelines significantly.
Handling DCT logistics
DCT logistics vary greatly depending on the aims of the trail, but a general overview and help envision how the pieces can fall together:
Oversight: Some may have concerns about safety and monitoring since patients may not interact with the Principal Investigator (PI) regularly. It’s important to know that patients still have routine televisits with PIs. Depending on study design, teams can combine virtual and in-person visits at investigator sites. Either way, the PI still maintains oversight of all patients – just like fully site-based studies.
Primary care physicians (PCPs) and general practitioners (GPs): These professionals can still support standard of care activities. They can provide physical exams, measure vital signs, and complete blood workups. They share all the data they collect with the Principal Investigator (PI) of the trial. The PI is fully responsible for ensuring oversight.
Drug and vaccine delivery: Depending on the study, research teams can ship drugs or vaccines to patients directly. This is already happening in many studies. There are processes to ensure a treatment reaches the correct participant in the proper condition.
Nursing support: While regulations vary region, many third-party organizations partner with sites for home at-home nursing and routine bloodwork.
Studies that are good for decentralized clinical trial pilots
There has been a lot of success with long-term follow-up studies, along with studies that involve a lot of specimen collection and routine lab testing. From a therapeutic area perspective, CNS/neurodegenerative studies, rare disease, and other areas where requiring patients that are either physically unable to travel to a site without additional support or are spread out far away from sites, are all good candidates.
It’s worth auditing your study design and seeing if technology could have a valuable impact on your efforts. To reap the benefits of decentralized trials, you don’t need to go completely virtual. Don’t miss out due to fear or resistance to change – regulators are in support. There are so many populations in need and your organization could increase the potential to have a positive impact.
If you’re interested in learning more about how a closed-loop decentralized system works, check out this infographic.