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.
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.