Discovery and Validation of Biomarkers, Endpoints, and Signatures for Pain Conditions
The Research Need
Only a small fraction of new pain medications advance from safety testing in humans to approval by the U.S. Food and Drug Administration. One reason is because the research community lacks specific, measurable characteristics, or biomarker signatures, to assess pain objectively in individual patients.
About the Program
The program funds research to identify specific, reproducible characteristics of pain conditions (biomarker signatures) that reflect indicators of a normal or abnormal process, a condition or a disease, or a treatment response. These characteristics can be used to define pain levels objectively as well as to predict the development of chronic pain from injury or various diseases.
Careful selection of research participants for pain clinical studies based on these specific, measurable characteristics (called signatures or phenotypes) can improve the success of clinical trials by reducing variation among participants as well as developing a more precise set of targets. A program goal is to develop new, individualized therapies based on specific pain-related characteristics and predictive models. Novel treatments can then be tested through program-funded prospective clinical studies or through the Early Phase Pain Investigation Clinical Network (EPPIC-Net).
Because many individuals have more than one type of pain, the research leverages existing clinical studies to follow subsets of participants with two or more chronic overlapping pain conditions and determine relevant features that can serve as markers for development, progression, and treatment response to these conditions. The program also funds exploratory research, including with nonpharmacological treatments for muscles and associated soft tissues (such as fascia, a highly understudied tissue type in many painful conditions).
To date, through the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, NIH has funded 16 awards for this program, totaling $46.3 million.