Patient-centric healthcare has taken center-stage. With the increasing access to information, patients want to play a role in treatment methods and applications. Patient-centric sampling has an important part to play.

According to the National Institute of Health database, 50,000 clinical trials were registered with ClinicalTrials.gov in 2007. A decade later, the number had increased to more than 250,000 and has since increased by 10-12% every year.

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.

Multinational clinical trials are essential for the efficient provision of generalizable information to both medical and scientific fields. International trials involving several countries are especially vital for rare diseases. They allow for accelerated patient accruals and increased applicability of the research findings.

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.

The Challenge of AKU

Alkaptonuria, or AKU, is a rare and less-studied inherited metabolic disorder. It results from a deficiency of homogentisic acid dioxygenase (HGD), part of the tyrosine degradation pathway. As of yet, there is no cure. However, The National Centre for Alkaptonuria, hosted by The Royal Liverpool and Broadgreen University Hospitals, is supporting international clinical trials that may help change that. And clinical chemist Joseph Taylor says that Volumetric Absorptive Microsampling (VAMS^®) technology and Mitra^® devices already play an important role in the relevant drug development process.