understanding the dangers of pediatric clinical trials

The bodies of children work differently from those of adults, often dramatically and fundamentally so. To cope with devastating diseases, children require different sorts of pharmaceutical solutions and treatments, which must be developed and tested through a challenging process involving pediatric clinical trials.

Pediatric clinical trials pose more difficult challenges than those associated with clinical trials involving adults. They require stoic commitment, patience, and persistence, from children and from their adult caregivers. Extra steps must be taken to minimize pain and discomfort, since children are less prone to understand what they're going through.

The health risks to pediatric participants must also be minimized as much as possible, since children cannot consent to subject themselves to such hazards in the same way adults can. The demands of adherence, compliance, and subject retention in this fraught context are on an entirely different level.

In an interesting and important interview with the website Outsourcing-Pharma.com, Catherine Y. Spong, M.D., of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, explores in depth some of the most bothersome difficulties associated with designing and conducting pediatric clinical trials. Practical, logistical, financial, legal, and ethical concerns are raised on a routine basis.

The human toll of cruel and ill-advised medical experimentation on children comprises some of the darkest chapters in medical history. Suffice it to say that those responsible for pediatric clinical trials must always err on the side of caution, comfort, and convenience on behalf of children and families affected.

Organizations such as the FDA and the Pediatric Trials Network track the medical, scientific, and technological advances that make pediatric clinical trials more palatable and worthy of support and success. Among these is the proliferation of dried blood spotting, or DBS, a blood and specimen collection technique that draws less blood and causes less pain for clinical trial patients, particularly children and the elderly. But traditional DBS methods, involving cards and filter paper, have significant drawbacks that have hindered widespread adoption.

Volumetric Absorptive Microsampling (VAMS™) represents the next generation of dried blood spotting. It solves for the limitations and ambiguities of DBS while maximizing its advantages. It boasts strong applications across pediatrics.

If you are involved with pediatric clinical trials, you owe it to yourself, and to the community you serve, to educate yourself about the uses of microsampling. We can help.