new comfort and convenience for clinical trials

It can be challenging to recruit and retain research participants for clinical trials. Two reasons are the time commitment required and the inconvenience of participation. People would be much more likely to volunteer for clinical trials if they could do the majority of clinical procedures and activities from home, at times that work best with their schedules.

New, remote devices and digital technologies mean that this is possible, making the drug development process simpler. Recruitment, retention, adherence and compliance for clinical trials can be improved. Significant points of friction can be removed by following a decentralized clinical trial model. Powerful changes can be as simple as the way blood samples are taken.

Microsampling Devices Make Blood Collection Quick and Easy

The technology available for collecting blood samples – a critical component of clinical trials –has advanced. With newer remote microsampling technologies, portable devices like the Mitra^® device or hemaPEN^® based on volumetric microsampling can be sent out to research participants at home to collect their own blood samples from a simple finger-stick.

After an initial training session with clinical trial managers, patients can be offered the option to participate remotely in a mail-based study using Mitra^® Sample Collection Kits or to participate in a traditional onsite study. A hybrid clinical trial may also be an option, where some of the onsite clinic visits are replaced with virtual "visits" conducted via phone or video chat (i.e., Zoom).

These new models for decentralized clinical trials or hybrid clinical trials using remote microsampling and remote kits widens and deepens clinical trial recruitment pools. This approach also dramatically improves the patient experience, especially for vulnerable populations including children, the elderly, and the immuno-compromised who need to shelter at home. Remote sampling also improves access for those in low-resourced regions.

Even for onsite blood collection, clinical trial staff often prefer finger-stick sampling:

“The nurses taking the blood samples preferred the [volumetric microsampling] method over the DBS method. Mitra doesn't need a ‘drying period,’ because the packaging is designed to not touch anything. Therefore, the Mitra device can be put away immediately.” – Jennifer Keiser, PhD, Swiss TPH

Volumetric microsampling with Mitra is based on a patented VAMS^® technology, which is designed to help anyone, anywhere collect a precise volume of blood for scientific analysis. The volumetric absorptive microsampling tip on the end of a Mitra device absorbs just a few drops of blood in precise volume from a lanced fingertip. Watch the video to learn more:

Study participants can collect small, precise samples of blood (or another biological fluid) at home, or anywhere by following the illustrated instructions included in the kit. They easily ship their samples to the lab in the provided specimen pouch and envelope – using standard mail. Finger-stick sampling is considered less stressful and painful than venipuncture. 

“When I see how much easier it makes things for patients, when they can self-sample and take agency in the process, it really hits home." – Dr. Jon Jin Kim, Nottingham University Hospital

Pharma companies can bring new drugs to market in less time. Microsampling makes things a little easier for drug study participants and can make an enormous difference for research scientists and leaders in the pharmaceutical industry.

“With VAMS, we could just communicate that they don't need to come out of their homes. We send the kits via regular mail and instruct them to sample themselves.” – Dr. Christophe Stove, PhD, Ghent University

Small samples can make a big difference in pharma and clinical trials.

92% of clinical trial participants surveyed prefer at-home fingerstick blood collection.

Contact a Microsampling Specialist today to take your next step toward smarter, more person-centered clinical trials.

Image Credits: Shutterstock, iStock, Trajan Scientific and Medical, Neoteryx