Clinical trials are a critical part of determining the success rate for treatments. However, as the COVID-19 pandemic impacted how all industries operate, circumstances required significant changes in how clinical operations teams conducted clinical trials. This logistical challenge led to many lessons learned – and a realization of the primary benefits of decentralized clinical trials (DCTs).
Many pharmaceutical and medical device companies are turning to DCTs as an innovative solution offering a range of benefits for both patients and researchers alike. This post will explore why DCTs are becoming more popular and how they can create a better experience for organizations and patients.
What is a decentralized clinical trial?
A DCT is a clinical trial that is conducted without the involvement of a primary coordinating site. In contrast, centralized trials are usually controlled by a single coordinating center. While this method works and will continue, DCTs offer many benefits and often better results. Many organizations now also design trials that combine in-person and virtual elements, known as hybrid trials. The benefits of hybrid trials are also significant in terms of trial participant satisfaction and ultimate success.
In this case, the term decentralized describes the fact that the trial is not centrally administered. Instead, each participating trial site operates independently and reports to a central database that tracks participant enrollment, patient data collection, and other activities. Despite the challenges in decentralized health care, the approach continues to hold appeal for trial teams and patients.
5 benefits of decentralized clinical trials
Want to understand some of the reasons why non-traditional clinical trials are becoming more popular? Here are some benefits that continue to move DCTs from trending to preferred.
Create more opportunities for patients with limited access
Many people could benefit from participating in a clinical trial but have never had the opportunity because their location made it difficult for them to participate or their schedules didn’t allow it. According to research by McKinsey, about 70% of all trial participants live more than two hours away from the trial site, which can negatively impact trial participation. Historically, this has been an issue for pharmaceutical companies. A clinical trial can show effective treatment, but you may not get the complete picture if you miss out on patients with different experiences or insights.
By doing a clinical trial in a decentralized way, you provide options for those who can’t participate in a more traditional clinical trial setting.
More opportunity can often go hand in hand with increasing the diversity of the population in your trial. When you opt for a DCT, you have broader patient populations to work with. This is particularly important when you’re doing a clinical trial for rare diseases or conditions, and you may have trouble getting enough people to enroll.
Clinical trials with diverse populations are more likely to produce results relevant to a broader range of people, including minorities and economically disadvantaged participants. Improved access to clinical trials are another step the life science industry can take to achieve equality in healthcare.
Improve patient communication and participation
Technology sometimes gets a bad rap regarding its impact on communication. However, when you implement technology effectively, you can also increase effective communication. Technology empowers you to set up workflows to keep lines of communication open. It’s also easier for patients to fulfill their roles and share their thoughts of experiences.
As technology evolves, clinical trials can be conducted almost entirely through digital tools. While the impact of digital clinical trials is still emerging, it’s clear that technology will play an essential role in enhancing patients’ ability to participate in trials and communicate with investigators during the process. Already, more patients are willing to manage aspects of their health online. McKinsey reports that up to 98 percent of patients reported satisfaction with telemedicine, and a majority (72%) of HCPs reported similar or better experiences with remote engagement than in-person visits.
Boost patient recruitment and retention rates
While pharmaceutical companies or academic institutions can assemble their cohorts of volunteers who meet inclusion criteria for their research studies, getting the necessary populations involved in clinical research can prove challenging.
Research shows that globally, more than 80% of trials fail to enroll on time resulting in an extension of study or the addition of new clinical study sites. Similarly, insufficient clinical study participant retention through study closeout is also a concern.
Unlike traditional sites, decentralized trial sites can draw upon community-based organizations to maintain strong relationships with local leaders and decision-makers to increase patient recruitment in areas that may not otherwise be considered for traditional clinical trials.
In terms of retention specifically, it’s easier for clinical trial participants to do what’s asked of them when they don’t have to stray very far from their typical schedule or worry about travel. It’s a win-win for pharmaceutical organizations and patients.
Enhance data accuracy
One of the essential benefits of DCTs is that you can be sure that the data collected will likely be more accurate. Every clinical trial has the potential to see errors. However, you can often get clear and more applicable data as people participate in their real-world environments. When participation is convenient, patients tend to contribute their data more often or more consistently than if they need to arrange transportation or child care or take time off work.
The role of technology in non-traditional trials
During the pandemic, decentralized trials kept important work moving forward, and many clinical teams enjoyed the increased flexibility of the new model. The current challenge to proponents of the decentralized model is convincing other stakeholders not to return to pre-pandemic habits. To do this, champions of decentralized trials should lean into the economical aspect by emphasizing pandemic-era investments that have already been made, as well as the potential benefit of decentralized trials over time. “For DCTs,” says Hassan Kadhim, senior director and head of clinical trial business capabilities at Bristol Myers Squibb in PharmaVoice, “the worst thing that could happen is companies give up and they think [decentralized trials are] not worth (doing) anymore.”
Now that in-person visits are back, decentralized trial evangelists are facing [a] challenge — convincing the industry that DCTs are still worth pushing because the investments will pay off in flexibility for both patients and industry players. – PharmaVoice
What should pharma companies know about technology for DCTs?
The technology used in DCTs should be scalable across multiple sites and locations. It should also be easy to use and accessible to both KOLs and patients. Where possible, the technology should be uniform – for example, in the case of trials that use wearable monitors or sensors, a difference in brand, make, or model can cause variations in the data collected. In general, trials sponsors may use the following types of technology in the administration of decentralized trials:
- Wearable or home-based sensors or monitors
- Artificial intelligence (AI) platforms
- Video or audio assessment tools to capture patient input
- Patient surveys or inventories
- Online discussion platforms
How can an insights management platform support DCTs?
An insights management platform with asynchronous engagement capabilities offers a flexible way for trial sponsors to engage patients, investigators, and other stakeholders. Asynchronous engagement is not site- or schedule-dependent, and trial sponsors can use tools like moderator dashboards to ensure compliance and encourage participation over a period of days, weeks, or months. Insights management platforms can also include advanced technologies like AI-powered natural language processing or sentiment analysis, which may enable trial teams to identify trending concerns or topics among patients or investigators more efficiently.
Bottom line: The future of clinical trials
DCTs are more than just an alternative the industry is adapting to. In some circumstances, leveraging decentralized research sites may help pharmaceutical companies get the information they need better and faster.
Want to know more about the future of technology in the life science industry and how you can leverage digital tools to gain better insights? Check out our blog series on insights management for more information.