Patient Samples Key to Effective RBM in Biomarker-Driven Trials

Dr. Jian Wang, President and CEO, BioFortis

Dr. Jian Wang, President and CEO, BioFortis

Patient samples (biospecimens) are an increasingly important component of any effective risk-based monitoring (RBM) program, especially when it comes to biomarker-driven precision medicine clinical trials, says Dr. Jian Wang, president and CEO of BioFortis. Done properly, biomarkers can save time and money by helping identify the right type of subjects to include in the trial at the very outset, he says.

Unfortunately, many sites fail to grasp the importance of biomarkers. Specifically, they fail to properly manage and track biomarker samples as they are collected, stored, processed, and shipped. It can be a costly mistake, Wang says. Example: A trial manager recently told him that trials could be delayed four to six weeks if trial managers waited until the end of the process to reconcile biomarker samples.

Even as the complexity of the data has increased, patient biomarker data drives more and more trial decisions, Wang says. “Data must be timely,” he stresses. The risk of slow or missed biomarker sample and data? “You can lose patients because they don’t want to wait, they move on,” he says.

Webinar: How RBM Can Improve Precision Medicine Trials by Incorporating a Biospecimen-Centric Perspective – Join Wang July 18 to learn best practices in utilizing sample-centric risk-based monitoring components from a centralized monitoring perspective to empower your study teams with up-to-date, accurate, and actionable insights on sample activities and relevant consents on sample use. Addressing this missed opportunity in RBM results in improved trial execution, as well a reduced operational and compliance risks for both ongoing trials and future translational medicine studies. View Program Details

Adoption of technology and the use of biomarkers in trials is moving faster and faster. Education is not keeping pace, Wang says. For example, he says it’s not uncommon for samples to be collected from patients without garnering and documenting the proper informed consent. “If you don’t monitor that, you can have a problem” with the Food and Drug Administration and other regulators down the line, he says.

“Historically, trials have not been managed from a sample-centric perspective,” Wang says. That’s a big mistake when it comes to precision medicine trials, he adds. “If you don’t have samples, you don’t have biomarker data. If you don’t have data, you can’t make decisions.” Put another way, “in biomarker-driven clinical trials, patient samples are as important as patients themselves.”

Smart trial managers will put in place a program that gives them real-time reports on which sites are turning in the patient biomarker samples on time and with high-quality reports on the results, and which sites aren’t up to speed yet.

Wang and coauthors also published a column on this topic in the June Clinical Researcher titled Good Management Practice: Improving Precision Medicine Trials by Extending RBM Principles to Include Specimen and Consent KRIs.

Author: Michael Causey