What are Decentralized Trials? And Why You Should Care

Part One of The Decentralized Trials Series 

Over the past two years, there has been a mass migration to the digital sphere. Due to the COVID-19 pandemic, people began going to work, attending appointments, and hosting social gatherings online. As the world became remote, so did clinical trials. Thanks to “Decentralized Trials,” clinicians have the opportunity to diversify their data collection, optimize efficiency, and contribute to the ever-growing biotech innovations that help save lives.  

What Are Decentralized Trials?

Decentralized trials, also known as Hybrid Trials, are clinical trials that do not have to be performed at a central facility, allowing patient participation from anywhere in the world. This remote technology comes in various forms, such as telemedicine, mobile apps, or wearable health devices. Though decentralized trials have existed for years, they rose in popularity during the COVID-19 pandemic as the world’s population was in some form of lockdown. Today, decentralized trials serve as a more accessible option for people with disabilities, hectic schedules, or lack of access to transportation.

How Prelude EDC Can Optimize Decentralized Trials

We cannot be everywhere we want to be. Fortunately, Prelude has several Decentralized Trial options to help clinicians collect data at any time or place.  

• Prelude EDC: The Prelude EDC is web-based. Study participants can access the database with a secure internet connection. Our EDC allows for real-time data cleaning with robust edit checks, remote monitoring through our query functionality, and remote interaction between clinical operations and clinicians through email notifications. Meaning if the study protocol permits, Prelude EDC does not require on-site data entry or monitoring.  
• ePRO: Prelude EDC’s ePRO enables patients to input data directly into our electronic data capture (EDC) system, with a fully attributable audit trail, from their mobile device for a simple and efficient clinical trial experience. Data collection can now be done in the comfort of participating homes without any need to step foot into a clinic – reducing the need for in-person visits and the loss of subjects who do not want to risk their health by coming into a clinic.  
• Digital Paper: With the increase in decentralized trials, Prelude saw an opportunity to expand the tools needed for remote data collection. Introducing our newest decentralization tool, Digital Paper. Digital Paper offline data capture puts to rest any reservations about the full adoption of decentralized trials because of technological failure or Wi-Fi outage concerns. This tool was designed with production animals and agricultural studies in mind, for example, a clinical study where data needs to be collected on a herd of cattle in a field with no internet access. With the consideration of those working in remote locations, Digital Paper allows data entry to be submitted without Wi-Fi, then uploaded to the database once an internet connection is restored. Users do not have to worry about any data getting left behind!  

Benefits of Decentralized Trials

Increases Participation/Accessibility: Gaining site participation is often a first roadblock. Then comes subject attrition. A remote system for collecting data allows for the participation of patients with disabilities, busy schedules, young children, or limited access to transportation. Not only does this provide a more diverse dataset, but it also eliminates any anxiety or stress that might come with commuting to on-site clinical trials. As if subject enrollment was not challenging enough, at the beginning of the COVID-19 pandemic, there was a 74% decrease in subject enrollment (Sathian et al., 2020), a statistic that is still recovering today. Three years into the pandemic, encouraging participation in studies today still has its challenges to overcome. But pandemic or no pandemic, decentralized trials have made it easier than ever to obtain and retain subject participation and help subjects participate in life-changing trials.  

Eco/Time-Friendly: Gone are the days of paper piles and the tedious task of entering data by hand. Decentralized trials save both clinicians and subjects from wasting paper and time filling out paperwork as the digital aspect of an EDC collects data and users can sign forms with the press of a button. Then, factor in the patient commute. Decentralized trials help to eliminate time and energy waste just getting to and from the clinic, which can serve as an enticing tool for trial recruitment.  

Technological Increase in Clinical Space: The need for decentralized trials skyrocketed during the COVID-19 pandemic, and with that came the need for innovative technologies in the clinical trial industry. Technologies such as wearable devices that collect raw data of a subject while it is on their person, telehealth visits for doctors to meet with patients virtually, and mobile applications, like ePRO, allow remote patient data entry to facilitate collecting clinical data while adhering to “social distancing” guidelines.  

Decentralized trials grew in popularity during the COVID-19 pandemic and continue to grow as the public begins to resume pre-pandemic habits. It is no surprise as patients’ everyday need for mobility and flexibility benefits from the convenience of remote data collection. Clinicians also benefit from the features that come with decentralization (such as automated calculations and edit checks leading to increased data quality) and increased subject participation. Change can be intimidating, but the adoption of decentralized trials comes with significant advantages. 

Sources:  

Sathian B, Asim M, Banerjee I, Pizarro AB, Roy B, van Teijlingen ER, do Nascimento IJB, Alhamad HK. Impact of COVID-19 on clinical trials and clinical research: A systematic review. Nepal J Epidemiol. 2020 Sep 30;10(3):878-887. doi: 10.3126/nje.v10i3.31622. PMID: 33042591; PMCID: PMC7538012. 

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