As clinical research continues to evolve, decentralized clinical trials (DCTs) are becoming a central focus of innovation. The landscape of clinical trials is constantly transformed by regulatory changes, technology, and the growing need for more diverse and accessible participation. But what exactly are decentralized clinical trials, and what challenges and benefits do they bring? Let’s explore the key aspects of DCTs, how they can reshape clinical research, and what considerations to address along the way.
Defining DCTs
DCTs are studies where some or all trial activities occur away from traditional research sites. These activities can be conducted remotely, using technologies such as electronic consent (eConsent), clinical outcome assessments on smartphones or web platforms, and telehealth visits. According to the FDA Omnibus Reform Act (FDORA), a decentralized clinical trial allows for trial-related activities to occur at a location separate from the investigator’s site. This flexibility enables a more patient-centered approach to clinical research, potentially improving participant access, site experience, data quality, and study performance.
However, DCTs are not limited to technological solutions. While digital tools play a significant role, decentralized trials can also involve strategies like conducting studies in non-traditional settings such as participants’ homes, local pharmacies, or community locations like barbershops, making clinical research more accessible to underserved populations.
Benefits of DCTs
One of the most significant advantages of decentralized trials is improving access and convenience for participants. For many individuals, especially those living far from research sites, traditional trials can be logistically challenging. An estimated 70% of Americans live more than two hours away from a research site, making participation difficult. By decentralizing trials, researchers can bring the study to participants through mobile health services, home visits, and remote monitoring. This helps reduce the burden on participants and increases the trial enrollment.
Another key benefit is the potential for DCTs to enhance diversity in clinical trials. Historically, trials have struggled to represent the diversity of the populations affected by the diseases under study. By incorporating decentralized elements, such as offering remote options or conducting trials in community settings, researchers can engage a broader and more representative group of participants. This diversity is crucial for ensuring trial results are generalizable and new treatments are effective across different demographics.
Additionally, decentralized trials can offer operational benefits, such as faster enrollment, better participant retention, and potentially lower costs. Technology enables more efficient data collection, allowing for quicker assessments and fewer delays in trial execution.
Challenges and Considerations
While DCTs offer numerous benefits, they also present unique challenges. One key concern is the “digital divide” – the gap between those with easy access to technology and those without. While many participants may find eConsent and mobile data collection convenient, others, particularly older adults or individuals in underserved areas, may lack access to the necessary devices or internet connectivity. This disparity could inadvertently exclude certain groups from participation, raising equity concerns.
In addition, decentralized trials must consider participants’ preferences for how they engage with the study. A fully remote trial may not suit all participants or disease conditions. For example, some individuals may prefer face-to-face interactions for certain procedures, or simply appreciate the social aspect of in-person visits. A hybrid approach, blending decentralized and traditional trial elements, often provides the most flexibility, allowing participants to choose the method best suiting their needs.
Another challenge lies in ensuring proper regulatory oversight in a decentralized environment. Traditional clinical trials involve close monitoring by a principal investigator (PI) at a single site. In DCTs, where multiple locations and healthcare providers may be involved, maintaining consistent PI oversight becomes more complex. Regulatory frameworks, such as the FDA’s Form 1572, which governs investigator responsibilities, may need to be adapted to account for these changes. Likewise, institutional review boards (IRBs) must navigate new questions around data security, eConsent processes, and the operationalization of digital tools in a decentralized trial setting.
Representation and Equity in DCTs
One of the primary goals of decentralized clinical trials is to improve representation in clinical research. However, it’s crucial not to make assumptions about which populations will benefit most from DCTs. For instance, while some might assume older adults struggle with digital tools, many elderly individuals are quite comfortable with smartphones and other technologies. On the other hand, younger or lower-income participants may lack access to the necessary devices or internet connections for fully decentralized participation.
A thoughtful approach is needed when designing decentralized trials, taking into account the unique needs of different populations. This could involve offering both “bring your own device” options, where participants use their personal smartphones, and provisioning devices to those who need them. Conducting feasibility studies or literature reviews beforehand can help identify potential challenges and ensure the trial design accommodates the target population.
In addition, working closely with local communities to build trust and foster engagement is essential, especially in populations potentially harboring distrust of the healthcare system. Decentralized trials, by offering more flexibility and reducing the need for in-person visits, may actually help overcome some of these barriers.
A Patient-centered Future for Clinical Trials
Decentralized clinical trials have the potential to revolutionize the way research is conducted by making trials more accessible, efficient, and representative of the populations they aim to serve. However, to fully realize this potential, trial designers must carefully consider the needs and preferences of participants. A one-size-fits-all approach won’t work; hybrid models combining the best of both decentralized and traditional trials are likely to offer the most flexibility and choice for participants.
Ultimately, a successful DCT depends on putting patients at the center of the process. By engaging with communities, offering choices in how participants engage with the trial, and using technology where it makes sense, researchers can ensure clinical trials are both effective and inclusive.
