The Emergence Of A Hybrid Laboratory Testing Model In Pharmaceutical Clinical Trials

By Paul S. Savuto, MS, MBA 

Thought leaders aware of technology and standard medical practices, foresee the emergence of a hybrid laboratory testing model for clinical trials. As the cost of R+D continues to rise, pharmaceutical leaders are calling out for innovation to improve the return on investment, speed up delivery to market and by all means, maintain the highest standards of quality, safety and efficacy. In the clinical trial testing arena, sponsors and CROs alike are under the same pressures and constraints reminiscent of the struggles faced by their medical practice colleagues back in the 1990s (G.J. Kost in Priniciples & Practices of Point of Care Testing, 2002). Clinical laboratories used by physicians and hospitals were compelled to innovate and adapt to the demands of managed care to do more with less while doing it faster.

What is a hybrid laboratory?

The hybrid laboratory consists of distributed but clinically integrated testing. The principle of the Kost model is the use of more efficient diagnostic tools and connectivity to collect data at the patient’s side in order to reduce the time to therapeutic treatment. In the clinical trial application, point of care testing (POCT) serves to augment the testing paradigm to speed participant enrollment, improve participant retention, reduce sample shipment costs, and facilitate real time data collection.

Kost describes three fundamental “roots” of modern POCT, first invented then innovated and pioneered clinically: miniaturized biosensor-based whole blood analysis, on-site hemostasis testing, and glucose monitoring. Historically, accurate biosensors enabled medically essential whole blood test clusters to be performed quickly in operating rooms, intensive care units and emergency departments. Invention and innovation created compact, portable and handheld point of care (POC) instruments that simultaneously measure electrolytes, such as Ca+, K+, Na+, Cl- and Mg2+, blood gases (PO2 and PCO2), and pH and hematocrit or hemoglobin. Tests for metabolites, such as glucose, lactose, urea nitrogen, creatinine and other important analytes (eg. O2 saturation and co-oximetry) were soon included. In parallel, hematology, hemostatis, and focused test clusters such as Troponin I and T, CK-MB, myoglobin and BNP markers also migrated to POCT.

As the POC test menu of these analytes has expanded, adoption in the clinical arena has increased on a global scale. Since the 1990s, in-vitro diagnostic testing by hospitals, clinics and physicians has shifted more than 35% of all tests to POCT systems. In last 10 years, the use of the same POCT technology has now been incorporated in 11 major clinical trials resulting in 4 new drug approvals. In one trial, the pharmaceutical sponsor reduced the cost of shipping by $3 million using a POCT platform.

How is a hybrid laboratory patient-centric?

Criteria for inclusion or exclusion often involve a participant’s ability to achieve specific test values which may vary depending on the nature of the clinical trial. During the initial interview and exam, a point of care test can be performed simultaneously with acquisition of a small blood sample (ie. 50μl) by fingerstick. This not only saves time and enhances safety for the individual by minimizing the amount of blood required for testing but also facilitates the making of an informed decision about participation, thus streamlining the enrollment process.

Would-be participants who meet the clinical trial selection criteria may have challenges getting to and from an investigator site. With minimal training, a visiting nurse can perform many of the point of care tests at a participant’s residence, making collection of data independent of the participant’s ability to travel. Great convenience for participants increases the chances of them being retained throughout the course of the trial.

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