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.

clinical trials go virtual with remote specimen collection

by Neoteryx | 4 min read

shutterstock_1802287480Clinical trials are vital to advancing medical science, but they face many stumbling blocks. New technology has given researchers the ability to take clinical trials outside the trial site and into the virtual space. Remote specimen collection through microsampling (also known as remote sampling) uses newer tools like Mitra® devices and Mitra collection kits that engage study participants in collecting their own specimen samples remotely. This helps to modernize the clinical trial process and make it more convenient for volunteers. 

VAMS® technology is based on volumetric absorptive microsampling, which allows microsamples of any biological fluids (blood, urine, sweat, tears, etc.) to be collected anytime, anywhere, and by anyone who can follow simple instructions. The self-collected microsamples are then mailed back to the lab and analyzed by the researchers.  

Published study results using remote microsampling indicate that this approach provides accurate results that are comparable to those gathered from conventional sampling techniques performed onsite. Remote microsampling also offers a unique opportunity for researchers to broaden access of clinical trials to a wider group of study volunteers, who would otherwise not be able to participate. Remote specimen collection also allows trials to be run at lower cost, with greater efficiency, and fewer constraints.  

Expanding Access to Clinical Trials 

When potential study recruits are asked to visit a research center, hospital or clinic to participate in a clinical trial, it is likely they will only enroll in trials that are occurring close to their homes. Time and distance are factors of onsite trial participation that can reduce the pool of potential candidates from which researchers can choose. These factors can pose recruitment challenges for trial managers. This is especially true when a trial seeks participants with rare conditions that are harder to find in the local population.

Clinical trials also require committed participants willing to submit to regular testing and interviewing over a long period of time. But many subjects abandon trials early because they struggle to find the time to visit the trial site multiple times in a week or month. If they must absent themselves from work or school to attend appointments for the trial, the financial consequences are another factor that may discourage them from participating. Clinical trial participants may also avoid required specimen collection visits because they fear needles, and any associated pain or discomfort. 

Remote microsampling can be a solution to overcoming these objections. Remote specimen collection with portable tools like the Mitra® device with VAMS® technology can be used anywhere. Researchers can provide Mitra devices and Mitra® Collection Kits to open their trials to recruits from any location. Remote microsampling can usually be performed quickly and easily, which means that participants don't need to absent themselves from work or school to collect a sample. This approach is minimally invasive and self-directed, and it eliminates phobia-inducing visits to a lab or clinic for a conventional blood draw. Remote approaches make sampling easier, more convenient, and more comfortable for participants. All of this makes them more likely to join and complete a trial to provide useful data for researchers.

Remote sampling is also useful for maintaining safe conditions in instances where disease transmission is a concern. Remote sampling with Mitra devices was recently used by the National Institutes of Health (NIH) to study the SARS-CoV-2 virus safely and effectively for a nationwide population study of undetected COVID-19 cases. 

Remote Sampling Saves Time and Resources

There are many inefficiencies built into the traditional clinical trial process. Research staff members spend many hours each week coordinating onsite appointments, collecting samples, answering questions, and interviewing participants. This administrative work diverts resources away from more specialized and valuable work, such as data analysis.

Remote specimen collection eliminates many mundane and costly tasks, allowing researchers to focus on the work that leads to sharing and publishing their data to help improve public safety and clinical practice. It greatly reduces the administrative costs of an onsite clinical trial. In most cases, only standard lab equipment is needed to process and analyze remotely collected microsamples, so there is no need to acquire new equipment to transition to remote or decentralized clinical trials.

The physical space needed to house a traditional onsite clinical trial can be a stumbling block, so removing that challenge is a boon. Because onsite sample collection is no longer necessary with remote or decentralized approaches, institutions can often repurpose their trial sites for other uses, saving on facility costs as well.

Virtual Clinical Trials Offer Benefits 

Decentralizing clinical trials can bring benefits to participants as well as researchers. These "virtual" trials give participants the opportunity to access cutting-edge treatments that may improve their conditions. By enrolling as a study participant, they may receive personalized medical care that would otherwise not be available to them. Participants may also find that access to an experimental treatment provides them with some relief of a health condition when no other medical intervention has worked.  

Many clinical research participants genuinely hope to contribute to the development of new treatments and cures. In fact, this is often one of the main factors motivating patients to sign-up for clinical trials. Through their involvement, they hope to help and prevent others from suffering as they have suffered. Making it as easy as possible for participants to do this may help them commit to completing a trial as they also work on improving their health. 

Taking Clinical Trials into the Future 

Remote specimen collection using portable microsampling devices like the Mitra microsampler has the potential to revolutionize the way clinical trials are conducted, broadening horizons for both participants and researchers alike. There is no better time for drug development companies and the pharmaceutical industry to decentralize and virtualize clinical trials and begin reaping the benefits of the remote approach to sample collection. 

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Originally published Mar 29, 2021 9:00:00 AM, updated on April 12, 2021

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