clinical trial expenses: when costs add up

Clinical trials are necessary to determine whether medical products and treatments are safe and effective for humans. In the United States, successful trials must receive FDA approval through three phases before medical products or treatments are released to the general population. Even after Phase III approval, Phase IV continues to monitor the product's safety. In other countries, their regulatory agencies approve trials following similar processes and protocols.

How Are Clinical Trials Conducted?

When determining whether a medicine or procedure is safe and effective, the clinical trial monitoring 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 or procedure continues through subsequent stages, with each level involving more patients and measuring additional elements of efficacy and safety.

Blood Sample Collection in Clinical Trials

At various stages of a clinical trial, physicians, trial staff or technicians draw blood or other fluid samples from the study participants to determine the side effects, if any, of the prospective medicine or procedure. The study participants may be asked to provide blood samples at different time points in a single day or over a period of a week. In a Phase III Clinical Trial, the number of patients may be in the hundreds or even thousands, which means that many blood samples must be collected.

How Are Liquid Blood Samples Drawn and Transported?

The traditional method of blood sampling is with a needle puncture of a vein in the arm to draw a volume up to 10ml of liquid blood. Wet blood must be refrigerated immediately. If is going to be transported to a remote lab, it must be specially packaged, labeled, and kept refrigerated at a stable temperature during the journey.

The samples must be labeled as a hazardous material for shipment.

Blood sampling is a critical component of most clinical trials, yet shipping and handling liquid blood samples is an expensive process, that can add millions of dollars to the total cost of a clinical trial. Shipping a small, dry-iced blood sample or other biological sample via FedEx within the United States can cost over $175 per shipment.

Microsampling: An Efficient Alternative to Standard Blood Sample Collection

There are newer microsampling devices available that are based on a dried blood sample (DBS) approach. Dried blood samples are typically collected via a finger-stick with a lancet to collect a few drops of capillary blood. Dried blood samples don't require cold shipping or storage, so clinical trials that can transition from traditional wet blood sampling to dried blood sampling typically see a significant reduction in their overall trial costs.

Two advances on the DBS approach are volumetric microsampling and volumetric absorptive microsampling. The hemaPEN^® is an easy-to-use volumetric microsampling tool that collects 4 volumetrically identical capillary samples from a single finger-stick. When the end-user clicks it shut, the four samples are transferred to DBS paper disks inside the "pen" and are locked inside until lab processing.

The Mitra^® device is an easy-to-use volumetric absorptive microsampling tool based on VAMS^® technology. The Mitra device has an absorptive VAMS tip on one end, which absorbs a few drops of blood from a quick finger-stick with a lancet. When correctly filled by the end-user, the VAMS tip on the Mitra device collects a precise volume of blood needed for lab analysis.

Both the hemaPEN and Mitra device collect dried blood samples that do not need to be cold shipped to the lab. After sample collection, the sampled devices can be placed inside a specimen bag and a mailing envelope and mailed from the nearest post box via standard mail. A designated microsampling laboratory will process the samples following a DBS workflow. Lab equipment and analytical techniques have evolved sufficiently to evaluate such tiny specimens accurately.

Microsampling saves valuable time and money, reducing overall clinical trial expenses, by eliminating the refrigeration, packaging, labeling, and transport required for traditional blood samples.