the microsampling blog

In the US, use of the Mitra device is limited to research and non-diagnostic applications. In many countries outside the US, the Mitra device can be used as a sample collection device for clinical diagnostic applications, as referenced in some content.

new terms for remote research, virtual trials and monitoring

by Neoteryx | 3 min read

shutterstock_1725758620The COVID-19 pandemic and its shelter-in-place requirements greatly accelerated the adoption of digital healthcare technologies and remote research or healthcare options. Conventional research studies, including clinical trials, required participants to congregate at a central location for enrollment, monitoring, testing, and other necessary activities. With new advances in remote technologies and portable devices, it has never been easier to conduct remote clinical trials that do not require participants to be physically present at a facility or trial site.  

Trial organizers have much to gain from pivoting to remote research; this model also provides cost savings and increases safety and satisfaction for both patients and staff. However, the rapid increase in the number of research organizations taking advantage of remote and digital technologies has led to some confusion regarding the meanings of many terms used to describe research studies that occur outside of a brick-and-mortar facility.

5 New Terms for Remote Research and Virtual Trials 

Here are five terms that may help to broaden your understanding of this burgeoning shift in the research and healthcare industries. 

1. Decentralized Clinical Trials 

While a conventional clinical trial is based at a central location where enrollment, specimen sample collection and testing takes place, decentralized clinical trials allow participants to take part in a clinical study remotely. With a decentralized trial, there isn't always a central brick-and-mortar location involved. Study volunteers who opt to participate from home can enroll in a trial, access trial information, self-collect specimen samples, submit health data, and speak to staff members without ever visiting a designated trial site.

For decentralized trials, self-collected specimens using portable tools like Mitra® devices can be mailed to a central lab for analysis, while health data and other information can be submitted online. Communications with staff may occur via email, phone, video chat or through an online forum. Training and orientation for trial procedures might also be conducted via video calls and email, with additional materials accessible online via videos, slideshows and illustrated instructions.

2. Hybrid Clinical Trials 

Hybrid clinical trials combine elements of centralized and decentralized clinical trials to create a unique type of study that can take place both on- and off-site. This model gives researchers the ability to offer the added flexibility of remote studies to participants while preserving the traditions and strengths of the conventional clinical trial process. For example, it can be helpful to provide orientation and training onsite and in-person, before switching to entirely digital and remote channels and processes. 

3. Virtual Clinical Trials 

Virtual clinical trials are decentralized trials that rely on virtual solutions. This term is common, but it is also slowly being phased out.

While the term "virtual" is not entirley inaccurate, its implications are somewhat misleading. To say that a clinical trial is "virtual" implies it involves computer simulation with no human participants involved. This is not the case.

Virtual clinical trials still depend on human participants for their results. Remote participants may use portable Mitra devices in remote sample collection kits, and "virtual" communications to contribute to the study from a distance, rather than by visiting a trial site. Some alternative terms that more accurately describe this model include “remote trials” and “decentralized clinical trials.” 

4. Remote Monitoring 

Remote monitoring (sometimes called “remote patient monitoring” or “RPM”) refers to the research team's ability to remotely observe and track trial participants’ progress through the duration of a clinical trial. This can be done using a combination of online surveys and questionnaires, phone or video call interviews, and remote specimen collection processes.  

Remote specimen collection, or remote microsampling, is the most logistically challenging of the three monitoring components, but it can be made much easier with the right tools for support.

Using Mitra® devices based on VAMS® technology, participants can self-collect a precisely-sized microsample of biological fluid like blood, urine, or even perspiration. These samples are intended to be transported and analyzed as dried specimens, making it possible to safely mail them to the trial laboratory by regular post. No cold-shipping methods are required. Participants mail in their samples using the provided packaging, which makes this option exceptionally convenient for trial volunteers.

5. Remote Source Document Verification 

Remote source document verification allows trial participants to submit their paperwork and other documentation online using secure digital processes paired with data warehouses and eClinical solutions. Email and fax are also occasionally used as supplementary methods of communication when legally possible. When combined with technologies like volumetric microsampling with Mitra® devices for at-home specimen collection, remote source document verification makes it possible for trials to operate with very limited physical contact between participants and staff. 

Clinical trials are evolving, and so too are the words or terms we use to describe them. Understanding when to use each term to describe a trial design is key to helping potential trial volunteers and others understand what type of study you are conducting. By clearly communicating that you are conducting a decentralized study that offers more convenience and flexibility to study volunteers, you can improve recruitment, adherence, and overall volunteer experience in clinical trials. 

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Originally published Apr 19, 2021 9:00:00 AM, updated on April 19, 2021

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