Wielding the Double-Edge Sword of Cardiac Biomarkers in Clinical Trials: A Discussion with Dr. James Januzzi, MD

Validated cardiac biomarkers have been instrumental in drug and device development for the last several decades and have accelerated market approval by the regulatory authorities. Yet despite the salutary effects of biomarker utilization in cardiovascular clinical trials, inconsistencies in biomarker application and interpretation in clinical trials have hindered the realization of its full impact and arguably contributed to a stagnation of new drug development in cardiovascular disease, at a time when the need for new therapies is at an unprecedented peak.

In cardiovascular trials, surrogate biomarkers often appear in different regalia, as clinical endpoints, for eligibility criteria, and/or for safety monitoring. On the one hand, cardiac biomarkers may be used to help precisely carve out the right study population with surgical precision. On the other hand, biomarkers, if used inappropriately, may bluntly and inefficiently whittle the trial population and objectives.

Determination of appropriate study endpoints is the backbone of any drug development program. Cardiovascular clinical research requires a precise approach to ensuring that study targets are met. Thus, carefully planned applications of each biomarker must be clearly outlined at the start of development and should be used in conjunction with functional and quality of life endpoints to measure safety and efficacy of new therapeutic options.

Selecting appropriate biomarkers and thresholds for patient eligibility and patient safety monitoring throughout the course of a clinical trial can improve the efficiency of the study, duration of study enrolment, and enhance selection of the most appropriate trial population. Cardiac biomarkers, when used in conjunction with standard safety assessments can help to pinpoint safety concerns or identify markers of trial success.

James Januzzi, MD, Hutter Family Professor of Medicine, Harvard Medical School

Richard Lee, MD, Senior Medical Director, Medical Department

Liz Moore, DNP, MSN, CPNP-AC, CPN, Advanced Clinical Practitioner Manager, Medpace

Kelly Millhaem, MHA, Senior Clinical Trial Manager, Medpace