clinical trials go remote with at home sample collection

Clinical 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.

Recruiting study volunteers and following them during a clinical trial can often be done virtually, through telecommunications via email, online portals or chat rooms, and Zoom or other video-conferencing applications.

Remote specimen collection with microsampling uses portable tools like Mitra^® devices and Mitra Sample Collection Kits that engage study participants in collecting their own specimen samples at home. This helps to simplify the clinical trial process and make it more convenient for study volunteers. They can help advance science from the comfort of home.

Mitra devices with VAMS^® technology is based on volumetric absorptive microsampling.

This technology enables microsamples of blood or other biological fluids (urine, sweat, etc.) to be collected anytime, anywhere, and by anyone who can follow simple instructions.

The self-collected microsamples will dry on the device and can be mailed back to the lab via standard post.

In the lab, the microsamples will be analyzed following a workflow for dried blood spot (DBS) sample processing.  

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 pharmaceutical companies and researchers to broaden access of clinical trials to a wider group of study volunteers, who would otherwise not be able to participate. Studies that involve volunteers who participate remotely across wider geographies and more diverse populations are now referred to as decentralized clinical trials.

Remote specimen collection also eliminates the need for trained phlebotomists and other professional staff to perform the blood collection for a decentralized clinical trial. This allows trials to be run at lower cost, with greater efficiency, and fewer constraints.  

Expanding Access to Clinical Trials, Improving Enrollment

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 barriers to onsite trial participation that can reduce the pool of potential candidates for a clinical study. These barriers 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 participants who are willing to submit to regular medical testing and interviews over a long period of time. Many study participants abandon trials early because they find it difficult to visit the trial site multiple times in a week or month.

If study volunteers 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 blood collection visits because they fear needles, and any associated pain or discomfort. 

Remote microsampling can help overcome these objections. Remote specimen collection with portable tools like the Mitra^® device with VAMS^® technology use a quick and nearly painless finger-stick method. They can be used anywhere. Researchers can ship Mitra devices and Mitra^® Collection Kits to their trial recruits in any location.

Remote microsampling 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 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. Stanford Medicine at Stanford University also used Mitra devices to remotely study the effects of COVID-19 vaccines.

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.

The time has come 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. 

Image Credits: Trajan, Neoteryx, Shutterstock