Patient-centric. It’s a word we’re going to use a lot in this article. But when you’re talking about the importance of decentralized clinical trials (DCTs) you can’t really get around it because the very nature of decentralization has everything to do with what makes the patient most comfortable.
And when that happens, recruitment goes more smoothly and clinical trials fill more quickly.
Clinical trials used to be conducted at specific sites because healthcare professionals needed a central location to work together. But decentralization allows clinical researchers to conduct patient-centric trials that are designed to do the opposite. Instead of asking patients to come to a study site, you bring the study site to patients—eliminating the need for participants to overcome obstacles like work schedules, unreliable transportation, or the need for childcare.
But what else does decentralization mean in the context of clinical trials? What are some common challenges the healthcare industry is up against as a whole? And how exactly does decentralization improve patient retention and reduce trial costs?
DCT 101: What is a decentralized clinical trial?
When we talk about “decentralized clinical trials” we’re referring to structuring your clinical trial in a way that makes it easier for participants to enroll by eliminating unnecessary travel to traditional, centralized sites. In a decentralized clinical trial, clinical activities can be conducted in a participant’s home, a nearby healthcare facility, or a neighborhood hospital.
A common misconception is that healthcare professionals can (or should) be absent from a decentralized clinical trial. Decentralization refers to the ability for patients to remotely participate in a clinical trial. It also doesn’t mean that physical contact with a patient is unnecessary. Instead, decentralized clinical trials allow healthcare professionals to more quickly and easily gather data. They enable sponsors and clinical researchers an alternative to a centralized, site-anchored, and inflexible system that often results in high patient drop out rates and lengthy delays.
The benefits of decentralizing your next clinical trial
Decentralized clinical trials increase the likelihood that your patient recruitment efforts will be successful by making participation more accessible and convenient, with benefits including:
- Patient-Centric Philosophy: Decentralized clinical trials allow patients to participate from their homes or an alternative venue that’s likely to be more comfortable for them. That means a lower barrier of entry from the beginning, which expands the pool of qualified participants and leads to higher levels of engagement and retention. The more convenient it is for a patient to participate, the more likely they are to do so.
- Flexible Solution: If there’s a public health crisis with mandates on travel restrictions and physical distancing (such as the recent COVID-19 pandemic) decentralized clinical trials allow for medical research to continue safely.
- Broader Reach: Decentralized clinical trials also allow for a wider geographic reach during enrollment, which enables patient participation from individuals in remote or underrepresented areas. This can help your trial meet all diverse representation requirements, while leading to findings that are even more applicable to the general population.
- Quicker Enrollment: Who doesn’t want accelerated enrollment for their next clinical trial? Decentralized trials can lead to a more efficient patient recruitment process by quickly reaching a larger pool of potential participants.
- Reduced Costs: It can be expensive to conduct traditional trials at physical study sites. Decentralized trials can reduce costs such as upkeep, maintenance, and rent.
- Real-World Context: When you allow participants to participate in their natural environments, decentralized trials allow healthcare professionals to collect real-world data alongside clinical data. What is their living environment? What have they been eating recently? What’s the air quality in their home or apartment? These insights can provide a more comprehensive understanding of a treatment’s effectiveness.
Why is the healthcare industry slow to adopt DCTs?
While decentralized clinical trials offer a number of advantages, the healthcare industry has been slow to embrace them fully. The most common fears are centered on digital literacy, patient data security, and regulatory compliance. But do those challenges outweigh the benefits?
As it pertains to digital literacy, Insider Intelligence predicts that 90% of North Americans will be internet users by the end of 2024. Partner with a patient recruitment company that specializes in digital audience targeting and can clearly communicate each step along the enrollment path.
Patient data security is crucial. Spend extra time ensuring that your team (and your vendors) have robust protocols to address these concerns.
Lastly, federal regulators support decentralization. You’ll need to stay up-to-date on any new guidance so that you can modify processes as you go, but regulatory bodies want results from diverse and underrepresented populations and have shown greater flexibility in how they communicate any new guidelines.
1nHealth: DCTs are in our DNA
Patient recruitment is about finding the right patients for the right clinical trials, and decentralized clinical trials are gaining momentum in medical research because they allow research participants to participate remotely. This is especially important in circumstances when travel restrictions or physical distancing precautions prevent clinical trials at traditional research sites. Since 2019, 1nHealth has been recruiting for DCT studies. Take a look at our experiences and see how we can help. Click here to connect with us today.
