By Paul S. Savuto, MS, MBA Blinded Diagnostics
Potential clinical trial participants and sponsors typically wait 2-3 days for lab results to determine eligibility. For the would-be participant every day that elapses could contribute to the loss of interest and increase the risk of losing a potential study subject for many reasons. And for the pharmaceutical sponsor, delays in enrollment increase the costs of the study and impact the future revenues from commercialization. Sponsors are well aware that the availability of lab test results can make a difference in the completion of key milestones in a clinical trial project. The shipping process of blood samples for a standard battery of chemistry tests represents the most significant cause of the delay as most laboratories can complete a battery on the day they receive the sample. In addition to the time lag, shipping lab samples in test tubes typically adds 25-35% of the total cost of central lab testing. In short, shipping blood samples for enrollment is not only slow, it can be very expensive.
Pharmaceutical sponsors are adapting to improved methods to reduce shipping delays and costs.
Technology used in major university medical centers around the world as a standard of care offers a unique opportunity to pharmaceutical companies engaged in clinical trials and actively enrolling patients. The standard of care in hospital emergency rooms, trauma centers, operating rooms and ICUs provide clinicians the ability to quantitatively assess a patient’s medical status within minutes because urgent treatment decisions are required quickly. Even in the most efficient hospital laboratories, a “STAT” chemistry sample has to be transported to the lab, logged in, spun by centrifuge, processed by the technologist and only then can results be sent or called in to the physician. In most cases, turnaround time (TAT) is 45 minutes for the entire “STAT” process. Clinicians in this setting demanded faster results. In the late 1990s, point of care (POC) manufacturers developed micro-sensor and dry reagent chemistry test platforms. These multi-test POC chemistry devices enabled clinicians to get lab quality results in less than 5 minutes, changing patient outcomes and reducing hospital treatment costs.