Pediatric clinical trials aim at boosting public health by ensuring safety in child medications. Clinical trials involving children pose challenges distinct from those focused on adults. Approximately 40% of the tests carried out between 2008 and 2011 were uncompleted.
The challenges preventing successful clinical trials are economic, ethical, physiological, and pharmacometric. One big reason is the collection of venous blood. But that's starting to change.
The Swiss Tropical and Public Health Institute is at the forefront of important research using Volumetric Absorptive Microsampling (VAMS®) technology and Mitra® microsampling devices in low-resourced regions. Recently, it tested Mitra® devices against more traditional Dried Blood Spot (DBS) cards in pediatric PK studies in rural Côte d’Ivoire.
Clinical trials must run smoothly to facilitate the development of new drugs. These trials must be conducted under specific guidelines to abide by the law that protects both the test subjects and the companies conducting trials. Below is a summary of the new Draft FDA Guidance on Pediatric Clinical Assays.
Venipuncture is painful. It's frightening. When you're performing research with, or delivering healthcare to, vulnerable patient populations, it can pose a significant impediment.
Traditional blood draws are particularly unpleasant for children - pediatric patients can't fully understand what's going on. With elderly patients, the very ill, or those in low-resourced regions, other difficulties can arise, such as the inability to make long-distance visits to clinics for blood draws.
The most vulnerable patient populations - elderly patients, children, those in low-resourced regions, and others - tend to have the most significant difficulties with venipuncture.
Working with capillary blood in these contexts can potentially make things easier. However, older methods of dried capillary blood collection, such as dried blood spot (DBS) cards and filter paper, suffer from limitations (most notably the hematocrit bias) cramping their ability to get specimens that can in turn generate high-quality data of the sort that is needed to better serve vulnerable populations in healthcare.
Enter Volumetric Absorptive Microsampling (VAMS®) technology, the better dried blood collection system behind the breakthrough Mitra® device. VAMS® is making capillary blood collection easier for vulnerable patient populations and, for pediatric patients, much less intimating.
The telegraph and the telephone were the precursors of modern telemedicine. Doctors could talk to each other over long distances. The space program made great advances in the technology over even greater distances. Then along came the internet and telemedicine was up and running.
Quantitative, volumetrically accurate blood microsampling technology is an indisputable boon for scientists, researchers, and the entire field of health and wellness. And it also makes life easier for organ transplant patients and their families. The experience of one family in England illustrates how.