clinical trials: when costs add up
Clinical trials are necessary to determine whether medical products and treatments are safe and effective for humans. Successful trials must receive FDA approval through three phases before being released to the general population. Even after Phase III approval, Phase IV continues to monitor the product's safety.
How Are Clinical Trials Conducted?
When determining whether a medicine or procedure is more effective than an existing option, the clinical trial phases begin with only a few patients to determine whether the product has any apparent detrimental side effects. If approved at this earliest stage, the candidate medicine continues through subsequent stages, each level involving more patients and measuring additional elements of efficacy and safety.
At various stages of a clinical trial, physicians or technicians draw blood or other fluid samples to determine the side effects, if any, of the prospective medicine or procedure. In a Phase III Clinical Trial, the number of patients may be in the hundreds or even thousands.
How Are Liquid Blood Samples Drawn and Transported?
The traditional method of blood sampling is with a needle puncture of a vein and a draw of a volume up to 10ml. The blood must be refrigerated immediately and, if transported to a remote lab, specially packaged, labeled, and kept refrigerated during the journey.
The samples must be labeled as a hazardous material for shipment.
Handling liquid blood samples is an expensive process, often adding millions of dollars to the total cost of a clinical trial. Shipping a small, dry-iced biosample via FedEx within the United States can be over $175 per shipment.
VAMS: A More Efficient Alternative to Standard Blood Sample Collection
Volumetric Absorptive Microsampling (VAMS™) involves drawing a single blood drop from a simple finger prick. Using the FDA Class One Mitra® Microsampler by Neoteryx, the sample can be self-drawn with a precise amount of blood absorbed into the tip. The microsampler folds back into the protective case and may be sent by ordinary post, without refrigeration nor special handling, to the laboratory destination. The samples are only 20µl (microliters), roughly 1/500th of the volume of a standard specimen. Equipment and analytic techniques have evolved sufficiently to evaluate such a tiny specimen accurately.
Microsampling saves valuable medical research money by eliminating the refrigeration, packaging, labeling, and transport required for traditional blood samples.
Topics: Clinical Trials