the microsampling blog

In the US, use of the Mitra device with blood is limited to research and non-diagnostic applications. In the US, the device is not for use with saliva samples intended for clinical DNA testing. In many countries outside the US, the Mitra device is approved as a remote blood sample collection device for some clinical applications, as referenced in some content.

how remote microsampling supports virtual clinical trials and cuts costs

by Neoteryx | 5 min read

shutterstock_1725021514According to a 2014 study, the cost of developing a new drug is $2.6 billion. This high expense doesn’t include the additional cost of post-approval development to determine dosage strengths and formulations.

An expense breakdown of clinical trials for new drugs showed that the factors influencing the costs most were onsite clinic visits and the number of study participants required to establish treatment effects. The analysis estimated that the per-participant expense for an onsite trial averaged $41,413, with each individual trial site visit incurring a cost of $3,685 per person.

These findings highlight the need to adopt cheaper ways of performing clinical trials. One way would be to take a remote approach to clinical trials, and eliminate the need for onsite visits to a central facility. A decentralized clinical trial (DCT) model utilizing digital communications paired with remote specimen collection for remote monitoring has become a popular solution. This model reduces the overall cost of performing clinical trials. It’s also more convenient for clinical trial participants, which promotes retention rates.

What Is a Decentralized Clinical Trial?

Traditional clinical trials have physical sites where study participants using the drugs, medical devices, and other new therapies are monitored and tested onsite. A decentralized clinical trial is conducted remotely with study participants remaining at home. Trial staff utilize telehealth communications, web-based platforms, digital devices, apps, wearables, remote specimen collection and other remote tools. A decentralized trial reduces reliance on physical clinical visits and intermediaries. 

A decentralized model relies on remote monitoring of participants. This means that study participant data is collected using digital and other technologies that enable people to eliminate or reduce their onsite visits. This shift has led to the development of remote tools, such as microsampling devices, that allow untrained study participants to collect their own specimen samples that can be mailed to a lab for scientific analysis and validation.

The decentralized model also redefines how data is collected. In the past, a professional from the study team would collect and record data in person, using a hardcopy case report form. The data would then be manually uploaded to a computer system to provide evidence in support of the study endpoint. The information would be used to monitor participants and inform them about future protocols. 

With decentralized clinical trials, digital platforms and applications (apps) are used to collect more endpoint-supporting data. As such, most of the data collected is participant-generated, either via a web portal where they can input their information from a home computer, or via a wearable device that automatically sends digital data to a central computer. Participant-generated data input reduces the need for trial staff to perform data collection and data entry tasks. This cuts down on staffing costs and often delivers data more reliably and efficiently. These digital and automated data collection methods are key components of a “virtual" or decentralized clinical trial.

Why Decentralized Clinical Trials Are Attractive

Decentralized clinical trials (DCTs) present five major benefits to clinical research organizations and study participants, including:

1. Reduced Clinical Procedures

According to an infographic from Clinical Research.io (CRIO), staffing & administrative activities (20%), and clinical procedures make up the highest percentage (20%) of the overall cost of a drug trial. This is primarily because of the number of site visits participants make during a trial. Clinical trials reviewed by ISMP showed that each study participant makes approximately 11 site visits or more, adding up to $2 million to the overall trial cost.

DCTs use digital technology to reach and engage patients directly. Digital tools and remote specimen collection devices, such as the easy-to-use Mitra® device, work in tandem with a trial website where participants can get information and submit feedback, reports, and more.

DCTs also reduce site-related costs. Since the model isn’t site-dependent, most trials only need one central location from which to coordinate patient involvement. This location might be a researcher's lab or office, rather than a larger trial site that must be specially allocated, leased and monitored following specific regulatory guidance as required for participant visits and trial activities. The reduction in the number of trial sites needed is another driver of cost savings with virtual clinical trials.

2. Easier Sample Collection

Most clinical trials, particularly drug trials, require blood tests to help researchers examine drug concentration levels, side effects and potential toxicity, as well as benefits and efficacy related to drug dosage.

Previously, blood tests have been performed using vials of wet blood samples. Wet samples were collected onsite by trained staff using traditional phlebotomy methods, such as venipuncture. Trial costs using these methods were significantly higher because wet blood needs special handling, cold-chain shipping and storage to maintain its integrity and stability for clinical testing.

With virtual clinical trials, remote sampling kits like Mitra® Collection Kits are shipped out to study participants. The kits contain portable Mitra devices for easy and convenient sample collection by study participants at home. The samples collected with these devices, based on volumetric absorptive microsampling, are analyzed in the lab as dried blood specimens. For this reason, no cold-chain shipping or storage is required.

A finger-prick method is used by participants to self-collect blood samples. The participant can mail their samples back to the research lab for analysis using the regular postal system. No medical professionals are needed for sample collection and no special shipping or storage mechanisms are required. This lowers costs substantially.

This participate-from-home approach presents three other advantages for study participants:

  1. Most trial activities are completed at home, including virtual communications with trial staff
  2. No need to visit the trial site for multiple blood draws
  3. No travel involved for routine tests

3. Leverages Real-Time Data

The success of virtual clinical trials depends on the ability to leverage digital resources. Researchers need real-time data to monitor changes in study participants. With digital applications and wearables, clinical researchers can obtain this data directly from the patients. 

4. Covers Wider Geographical Areas

Decentralized clinical trials allow researchers to recruit participants from more regions because there’s no need for travel. There’s better access to participants across wider geographies, and across broader demographics such as sex, race, age, and others. This approach helps diversify the pool of volunteers, which is essential when collecting data for trials.

5. Improves Volunteer Retention

Traditional clinical trials experience a high drop-out rate because of the amount of time, disruption and resources required. Some participants find they are missing too much work, school, and other activities to continue attending trial visits. This isn’t the case with DCTs.

Remote monitoring and communication technologies enable researchers to collect samples remotely and check-in with the participants virtually as often as necessary without waiting for a face-to-face visit, as in traditional clinical trials.

The researchers can collect biometric information, like heart rate or activity 24/7. With most activities being completed from home, trial participants are more likely to comply with the requirements and stay committed through the completion of the trial. With the right tools in place, a decentralized clinical trial is a win-win for everyone.

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Originally published May 24, 2021 9:00:00 AM, updated on May 24, 2021

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