Ensuring Patient Centricity In Oncology Trial Sample Management

By Hope Meely and Mark Melton, Slope

Oncology clinical trial participants are required to contribute various biological samples — such as blood, saliva, and tissue — to demonstrate how a study drug could potentially affect their disease. Collecting, shipping, storing, monitoring, and recording data on these samples is a complex undertaking with significant ethical implications. The collection process can be difficult for patients, especially when it involves highly invasive procedures, such as multiple blood draws, biopsies, or spinal taps. Not only is valuable data lost when samples are mismanaged, but participants may be asked to provide more material; this creates undue physical burdens on persons already dealing with a severe disease.

Sample mismanagement can result in a participant being excluded from a trial entirely — and even prevented from enrolling in other trials that could have used the same sample. Pharmaceutical companies investigating oncology drugs must strategize their sample management processes as early as possible to consider the burden to the patient while still meeting study objectives.