If you’re pursuing a career in clinical research, you’re probably already aware of the essential nature of clinical research trials in the safe development of new treatments. However, the established clinical research trial process has long been hindered by drawn out timelines, outdated methods and strain related to extensive resources.
Recently, both decentralized and digital clinical trials have gained prominence as new methods of doing what clinical trials have always done: gathering data from participants using a treatment or drug within a controlled setting and time frame. Both have the power to change the way that clinical trials are conducted, offering a better experience for trial participants while enhancing the efficiency of the trial process.
While the terms decentralized and digital trials are often conflated, they have different meanings. Below, discover the distinguishing features of digital and decentralized clinical trials, and learn more about how they’re both expected to shape clinical research as a whole.
Differentiating Between Digital and Decentralized Clinical Trials
In order to understand the difference between digital and decentralized clinical trials after getting your clinical research diploma, it’s important to clarify the relationship between the two terms. A digital trial itself can be decentralized in nature, while digital methods can be used in a decentralized clinical trial. By definition, a decentralized clinical trial has these defining features:
- Conducted at a distance from the principal research facility
- Clinical trial visits are made remotely, either through:
- Visiting another location for a face-to-face interaction
- Virtual visits: submitting electronic reports, video conferencing
In essence, decentralized trials improve accessibility, making it easier for those who live away from where the trial is being conducted to participate.
Digital clinical trials, on the other hand, are defined by the lack of any paper documentation. Everything is digitized, including the methods of capturing data. Unlike decentralized clinical trials, digital trials may use complex digital tools which can only be accessed within a trial centre, preventing participants from being located in remote areas.
Key Features of Digital Clinical Trials
There are a few different features that characterize a digital clinical trial. Depending on how these features are used, the digital trial may or may not permit decentralization. A trial is considered digital if there is:
- A digital protocol: a set of digital conditions which inform other digital systems, such as scheduling, assessments, criteria for inclusion and exclusion, safety protocols and more
- An eScreening system: eScreening systems in clinical trials will be linked to the Electronic Medical Record (EMR) system within research clinics. This application locates potential particiants based on information from the digital protocol, and research staff reviews its findings to determine patient eligibility.
- An eConsent system: This system digitally provides all information about the study to eligible participants, explaining the risks and advantages. Through this system, patients use digital documents to provide consent.
- Other linked systems: Other digital systems used to obtain and manage data may include: electronic clinical outcomes assessments (eCOA), a clinical trial management system (CTMS), an electronic data capture (EDC) system, virtual visit systems and more.
With these key features included, a trial can operate completely digitally, eliminating the need for paperwork.
Benefits of Implementing Digital and Decentralized Approaches After Clinical Research Training
After completing your clinical research training, it’s likely that you’ll see more digital and decentralized trials occurring in place of traditional clinical trials. This is because these types of trials pose several benefits, including:
- Enhanced recruitment of participants: Through digital tools, recruiting and assessing participants for eligibility becomes more efficient, reducing wait times and leading to greater transparency and trust in terms of consent.
- Reduced strain on participants: Decentralized trials allow for participation from home, while the digital communication tools associated with digital trials break down barriers to correspondence.
- More accurate data collection: Digitization optimizes the efficiency and accuracy of the data collection process and boosts the speed with which the trial can be conducted.
- Greater diversity: Decentralization and digital communication allow for a wider pool of participants, improving access for those of underrepresented or underprivileged backgrounds.
Given the potential that digital and decentralized clinical trials can have, in the future, we may see them implemented on a larger scale.
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