COAs, Biomarkers, and Endpoints, Oh My!
Establishing a common vocabulary accelerates progress by enabling effective communication and collaboration among stakeholders and facilitating cross-study comparisons and evidence harmonization. However, when we work with clinical researchers, they often use the words biomarkers, clinical outcome assessments (COA’s), and Endpoints interchangeably, but technically they mean different things.
I’m confident that my amazing team members often think I’m crazy when I deliberate or nitpick over the use of a single word. The point is words matter, especially in science and definitely in a new field like digital medicine. As this field evolves, definitions and key terms must be used consistently to reduce the hindrance of evaluating and interpreting scientific evidence.
The Digital Medicine Society (DiMe) and other experts in the field recently released an extraordinary resource – The Playbook: Digital Clinical Measures, an industry guide for successfully developing & deploying digital clinical measures across clinical research, clinical care, and public health. One of the most useful features is the purposeful use of language and defining standard terms used in Digital Medicine.
Here are some slides taken directly from The Playbook that describe the differences between Biomarkers, Clinical Outcome Assessments (COA’s), and Endpoints.“This material is based on ‘The Playbook’ generated and maintained by the DiMe Society at playbook.dimesociety.org.”
The Playbook is rich with these little nuggets of knowledge that will help advance the field of digital medicine through cohesive messaging, better science, and ultimately improved patient outcomes. For more information on digital medicine and the advantages of using wearable technologies in your clinical trials, visit our Science Blog or download the eBook 4 Key Principles of Digital Biomarker Development.