Decentralized Trials: Bringing Research to the People
Over the COVID-19 period the medical industry was pushed to innovate and adopt modern technologies at a faster rate than ever. One way in which these innovations have manifested is through the rapid adoption of decentralized methods of conducting clinical research trials. These are trials which are conducted in multiple locations, often including inside the homes of volunteers and patients, using digital testing, communication, and reporting tools. This breaks down many of the barriers to trial participation, allowing more patients to comfortably access trials and giving researchers more diverse and applicable data sets. However, there are a number of issues being faced by sponsors when establishing a decentralized trial. Massively increased costs, labor requirements, shipping delays, technological issues, and the ethics of patient privacy are just some of the stumbling points preventing full-scale adoption of the decentralized style. Until recently, adoption of decentralized trials had been slow, largely due to the firm regulations of the medical sector. Encouragingly, regulators appear to support decentralization and for the pharmaceutical industry to progress, the traditional site-centric clinical trial model requires evolution.
The Benefits of Decentralized Clinical Trials
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Reach — One of the strongest incentives for sponsors and researchers to adopt the decentralized model. By removing the “postcode lottery” as a factor in trial attendance, and also moving trial procedures into the comfort of patient’s homes, trials are able to be accessed by a much wider range of demographics. This means trials are going to the people, rather than people having to come to the trial, leading to more data for researchers, reduced participant dropouts and more representation for groups traditionally under-served by the medical industry.
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Simplified Patient Journey — A decentralized trial is a patient-friendly trial. They allow participants to spend more time with family, not have to miss out on work or make expensive travel plans, and focus on living their lives without being stuck in hospitals for extended periods. For chronic illness patients especially, this can be a huge increase to their quality of life. Additionally, digitization encourages participants to become more knowledgeable, informed and engaged in the clinical trial process.
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Diverse Data — For sponsors and researchers, the digitization that comes alongside decentralization allows for much greater data collection at all levels. On a macro level, sponsors are able to monitor aspects like participation, testing procedures, and workflows. On a more micro level, researchers have access to deeper levels of patient, clinic, and sample collection data sets. All this allows for much greater nuance in trial results, easier reporting and a greater transparency of management procedures.
The Challenges Facing Decentralized Clinical Trials
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Cost — Decentralized trials tend to be bigger, with larger teams across greater geographical areas than a typical clinical trial, meaning higher costs for labor and administrative processes. They also need to incorporate new costs like software licenses, the shipping of products and drugs, or specialized patient monitoring hardware like smartwatches or sleep monitors.
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Technological Accessibility — Both patients and staff can struggle to find the time to learn how to use new and unique monitoring technologies. Many patients also may need extensive training to use the new technology, or lack internet access, preventing them from participating in a trial that could be life-changing for them. Even if the staff member or trial participant is able to use the technology, incorrect use may lead to misleading data being provided to the study.
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Miscommunication — With so many additional communication layers added when decentralizing the trial process, it can be very easy for patients, staff, management, or sponsors to miscommunicate process details, data intricacies, or patient feedback. Additionally, when trials are happening across multiple locations, issues can arise around consistent reporting, visibility, and oversight between research teams. Protocol deviations can become common, and lead to inaccuracies in the final data sets.
Decentralized trials are still in their infancy, and evolving continuously through a number of challenges. With continued iteration and innovation of the trial process, sponsors will be able to provide trial participants with smoother experiences that lead to better treatment outcomes, and researchers with greater data sets that can be easily disseminated throughout the research community. Clinials is a digital platform facilitating greater participant recruitment, reach across a wider population and cross-team trial management, covering many of the challenges facing decentralized trials. If you’d like to know more, reach out at .clinials.com/contact today.