pediatric clinical trials: microsampling gives kids a better experience

Children often benefit from off-label use or new applications of prescription drugs, but they are not always well-represented in clinical research studies. One explanation is that children require special considerations when they are involved in clinical trials. Their welfare and wellbeing are of utmost importance. The willingness of the child’s family to support the child through the study also matters.

Several reasons deter families from enrolling their children as participants in clinical trials. Some parents worry about the adverse side effects of new, untested drugs on their children. Others fear there will be no health improvement despite their child undergoing tests and taking drugs for a long-term trial.

Other obstacles to participation in pediatric clinical trials include:

• Emotional and psychological impact – Children with chronic conditions that require frequent medical visits may associate the visits with pain and trauma, particularly if they involve needles for specimen collection and lab tests. This negative association may cause them to be less willing to comply with their medical care during or after pediatric clinical trials.
• Lost time, learning, and wages – Participation in clinical trials usually means absence from work or school for the study participants as they attend appointments for monitoring and follow-up. Traveling to and from the trial site to participate in the studies is also time-consuming and inconvenient.
• Pain, stress, or trauma – Clinical trials require routine blood testing, and poking a needle into a child's vein to draw blood can be painful. It is also stressful for parents to watch their child scream in pain and know the process will be repeated.

Remote Microsampling Is Changing the Clinical Trial Landscape

Since the 2020 coronavirus pandemic, clinical trials underwent changes as researchers turned their attention to fighting SARS-CoV-2 and Covid-19 illness. Scientists found creative ways to conduct their research when in-person visits were scrapped. They started performing trial "visits" virtually via video chats, mailing out medications and supplies, and asking participants to monitor their vitals at home. All this was an advantage to pediatrics research groups undertaking clinical trials.

Remote or decentralized pediatric clinical trials are now on the increase. Some trial managers are scheduling an initial onsite visit for training or orientation, and then conducting the remainder of the trial via a telehealth model.  A game-changing approach is to mail specimen collection kits to families at home. Specimen collection at home that is performed by a parent or other caregiver is less traumatizing for a child participating in pediatric studies. Stress and discomfort are reduced with at-home kits because they allow kids to stay in familiar surroundings for the specimen collection event, and the collection methods are minimally invasive—no big needle pokes in the arm.

One at-home kit is the Neoteryx Mitra^® Collection Kit, a remote specimen collection kit for self-collection by study participants. The Mitra^® devices in the kit are specially designed to easily collect bio-fluids such as blood, saliva, or urine. The kits come with easy-to-follow instructions and all the supplies needed for specimen collection. Videos are also available online for additional guidance. Families can help their children collect small "microsamples" for scientific analysis.

Study participants’ parents can then mail the samples on the same day they collect them to the designated lab in pre-paid packaging. After the specimen samples have been analyzed in the lab, research staff can follow-up and monitor study participants through web-based portals and video chat calls via Zoom or other video platforms.

With remote microsampling, it’s now easier to recruit and retain volunteers in virtual, or decentralized, pediatric clinical trials. Families appreciate the ease and convenience of participating in a trial from home, and are more likely to remain committed throughout the term of the study.

“We can now collect a sample at home using the device, mail it to the lab, and get accurate results without ever leaving home," says Caroline Knapp, the mother of a young kidney transplant patient enrolled in a remote pediatric therapeutic drug monitoring program in the United Kingdom. "The method is more convenient, as we don’t need to spend a whole day at the clinic for a blood test or visit, which leaves more time for school attendance.”