As advanced technologies continue to permeate the healthcare industry, decentralized clinical trials (DCT) are becoming more commonplace to capture healthcare information for organizations facilitating clinical trials.
DCT’s take some or all clinical trial’s activities that would otherwise occur at a traditional clinical trial site and make those activities accessible at other locations including the participant’s home, local health facilities or a laboratory located closer to the participant.
To do this, DCTs utilize digital health technologies to capture healthcare information for the clinical trials directly from individuals and can include technologies such as connected health devices, applications or wearable technologies.
“What they’re intended to do is represent an evolution in the way that clinical trials are conducted to enable greater accessibility and more convenience to patients that participate in clinical trials, while also utilizing technology to streamline the process,” said Senior Area Sales Director at HCLTech Kris Kingsbury.
Kingsbury adds that in a traditional clinical trial setting, 25 percent of participants live more than 100 miles away from that clinical trial site and 30 percent of patients end up dropping out of traditional clinical trials. By using DCTs and introducing digital technologies, organizations can have a more streamlined patient recruitment process and reduce geographical barriers.
Why choose a decentralized clinical trial
DCTs have become more prevalent as technology has improved, making it easier to collect, transfer and store electronic health information. Patients are allowed to participate in clinical trials digitally and in a remote setting. DCTs can then streamline the process and— along with the introduction of wearable devices, mobile apps and various types of technology platforms— facilitate data collection and centralize the viewing of that information, thus prioritizing patient centricity.
“The intent of DCTs are to prioritize patient centricity,” said Kingsbury. “It enables greater flexibility as patients participate in trials, reducing their burden of having to come to the site and accommodating individual needs and preferences of the patient.”
The myriad benefits of DCT go beyond decentralizing the clinical trial and reducing patient dropout rate. Eliminating geographic boundaries helps reduce any possible demographic restrictions. Additionally, time and cost savings are key benefits of DCT.
Being able to retain more patients for the trial can shorten the patient recruitment cycle which then compresses the timelines associated with clinical trials. The time saved then has a corresponding impact on the cost. According to Kingsbury, DCTs can save upwards of 30 percent of the cost to run a clinical trial versus one conducted in a traditional setting—depending on the size of the study.
Challenges to utilizing DCT
When it comes to using a decentralized clinical trial, organizations must focus on patient engagement, integrity, data, the evolving regulatory landscape and ensuring collaboration among all stakeholders in the clinical trial process. Stakeholders include sponsors and site investigators, as well as technology providers that provide various mobile apps and DCT platforms to collect information and the regulatory authorities.
“Additionally, making sure that you think of DCT and DCT components when drafting the protocol. You have to be very clear on those components that you want to include and what the expectations are of those components,” said Kingsbury.
Another challenge with DCT that organizations should be wary of is what will be required of participants in the clinical trial and to what level do they want to decentralize. Most studies right now still require some site-based aspects.
“The exception more than the rule are the fully decentralized sites where the patient never comes into a physical site,” said Kingsbury. “Most studies that are being conducted today still have a site-based component so they’re a hybrid study as opposed to fully site-based or fully decentralized.”
Further, with components of DCT being digital, organizations must ensure that they’re developing effective recruitment strategies. These new digital methods to engage with patients and try to gain awareness and gain participants must be thought through fully to ensure they’re getting the quality of patients that you want to inquire about the trial.
The road ahead for DCT
The future for DCT is one that is continuously evolving whether due to the technical advancements or the regulatory frameworks that impact DCT. According to Kingsbury, the focus will continue to be on patient centricity and ensuring that as much real-world evidence as possible is being captured.
Remote technologies and their expended use are going to be ever evolving with more sophisticated widespread remote monitoring tools, different types of wearables, various platforms and mobile apps all leveraged as a part of DCTs. Augmented reality and virtual reality will also be incorporated more as virtual visits for DCTs expand.
HCLTech’s holistic approach to helping customers successfully implement DCTs can help organizations move forward, with both patient recruitment onboarding, as well as through its capabilities both internal and through its partner ecosystem. HCLTech can assist customers by identifying the correct recruitment strategy for a particular clinical trial, highlight the appropriate channels to engage with patients and provide medical screening for patients and then onboard them and consent them into the study on behalf of their customers.
“HCLTech is taking that burden away from the trial sites to be able to identify, qualify and then onboard patients into participating in clinical trials,” Kingsbury said. “We’re able to also provide customers with the platforms and integrations to be able to conduct a clinical trial.”
For DCTs, the focus will continue to be on patient centricity and ensuring that as much real-world evidence is captured. Further, the regulatory frameworks and guidelines will continue to evolve and provide additional guidance to make it much easier for companies to design and conduct clinical trials.
