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the microsampling blog

unlocking the potential of remote microsampling in clinical trials

In the rapidly evolving world of clinical research, every detail matters. From the precision of the laboratory equipment to recruiting study participants from a broad geographic area and ensuring the comfort and convenience of those study participants, the quest for better, more efficient clinical trial technologies and methodologies is ongoing. One of the breakthrough technologies that has the potential to overcome many challenges of clinical trials is remote microsampling, or remote specimen collection.

DCT, global clinical trial recruitmentA handful of biotech device companies around the globe are committed to providing researchers who are working in drug development and other areas of pharmaceutical sciences more advanced and user-friendly tools. Remote and minimally invasive approaches to blood sample collection support clinical trials, public health studies and epidemiology studies more effectively and efficiently.

This blog delves into the myriad advantages of remote microsampling devices and how they can help transform the landscape of clinical research.

Study Participants Don't Want to Travel to Your Clinical Trial Site

A major concern in clinical trials is the collection of blood samples. Traditional blood collection methods require study participants to visit clinics or hospitals for frequent or routine blood draws performed by a nurse or phlebotomist.

While blood sampling in clinical trials may be necessary for gathering critical data, it can be inconvenient for study participants, especially for those living in remote or rural areas. In fact, the inconvenience of travel and discomfort of blood draws are obstacles that discourage people from joining clinical trials.

The Promises of Remote Microsampling

Mitra microsampling device in use at homeWith remote blood microsampling devices, such as the Mitra® device based on VAMS® technology or the hemaPEN®, in-person visits to the clinical trial site are no longer a necessity. Remote participation can be a huge game-changer for clinical trials.

Reluctant study recruits may be more likely to join a trial if there is a "mail-in" option. And those who might be inclined to drop out after a few site visits are more likely to stay committed if they can avoid travel and continue participating from home.

mailing the samples, no-cold-chainRemote devices allow study participants to collect their own blood samples at home and mail them to the research lab using standard mail.

This not only reduces the time and cost of commuting, but also eliminates the need for specialized handling and transport of the samples with dry ice or cold shipping.

The volumetric microsampling devices from Trajan are designed for dried blood sampling. Dried blood samples remain stable at room temperature during shipping. Analyte stability is often significantly improved when the matrix is dried blood versus wet blood.

Remote Microsampling: A Cost-Effective Solution

The economic benefits of remote microsampling are manifold. By eliminating the need for trained staff to perform blood draws for sample collection in a clinic setting, and by reducing the need for cold storage and shipping, microsampling offers substantial cost savings. Moreover, its efficiencies can help accelerate the time to market for new drug therapies, thereby boosting profitability for pharmaceutical companies.

Microsampling and Pediatric Studies

Pediatric studies present unique challenges. Traditional blood sampling methods can be stressful and potentially harmful for children. Many children are frightened of needles, making venipuncture blood draws a source of stress or trauma. Additionally, taking large-volume samples from small children can negatively impact their health.

self-collecting blood samples at homeWith finger-stick microsampling, a small lancet is pressed against a fingertip to prick it and draw tiny drops of blood in a minimally invasive process that is nearly painless.

The sampling process rapidly collects very small, "micro-sized" volumes of blood, making it easier and safer for small children. This innovative approach among younger, more vulnerable study cohorts has been backed by numerous case studies, leading to a shift in pediatric clinical trials.

Boosting Recruitment and Retention in Clinical Trials

collect blood samples with Mitra in the carMicrosampling removes the most common barriers to participation in clinical trials.

The flexibility to collect blood samples at home, in school, at the office, or in the car can significantly increase enrollment and diversity.

This remote and portable approach also enhances the comfort and ease for participants, leading to better adherence and retention in clinical trials.

Enabling Hybrid Clinical Trials

The advent of microsampling has made it possible to conduct Decentralized Clinical Trials (DCT) or hybrid clinical trials. After an initial clinic visit, participants can collect their own blood samples and other specimens at home, thus making the clinical trial process more convenient and patient friendly.

Trials are further simplified with microsampling devices that are based on dried matrix sampling, whereby the specimens can dry on/in the devices and remain stable at room temperature during their journey through the mail from the patient to the lab.

Reducing Technical Problems and Sample Risks

Microsampling reduces the risk of sample mishandling and degradation, ensuring analyte compatibility and stability. Our microsampling team at Trajan Scientific and Medical (Trajan) offers technical user guides, application notes and other resources to provide step-by-step guidance for sample collection, sample processing and analysis, and sample storage.

Streamlining Workflow with Automation

Microsampling devices are suited for manual or automated processing and analysis. For example, Mitra microsamples can be processed in the lab using the Mitra® 96-Autorack™ designed for use with automated instruments. This can help streamline and automate sample accessioning and processing. Our Neoteryx microsampling devices can easily integrate with your lab's dried blood spot (DBS) workflow with only minor adjustments.

Easing Logistics and Deployment

Remote microsampling devices make it easy for you to deploy sample collection kits and facilitate the return mailing of collected samples with minimal risk. The Neoteryx® microsampling team at Trajan collaborates with reputable third-party fulfillment companies to handle logistics in regions around the globe, ensuring smooth operations for your clinical trials.

Some Final Thoughts on Remote Microsampling

In conclusion, remote microsampling can be a real game-changer in the world of clinical research. The microsampling team at Trajan is dedicated to helping both large and small pharmaceutical organizations, Contract Research Organizations (CROs), and professionals across the research spectrum leverage the power of microsampling. Whether you are a researcher, a bench scientist, an executive, a lab director, or an operational professional, we are here to help you take your clinical research to the next level.

Do you need to recruit a more diverse study cohort? Do you need to find a low-volume sampling solution for a pediatric study? Are you trying to collect blood samples from study cohorts across a wide geography?

Embrace the future of clinical trials and contact our microsampling team to experience the difference!

Explore resources for designing a successful decentralized clinical trial (DCT) with remote microsampling.

In some territories our devices are supplied for therapeutic or IVD use Outside of those territories our devices are supplied for research use only

Image credits: Trajan, iStock, image commons

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