Developing Meaningful Endpoints for Pain Clinical Trials (Day 2)

More than 25 million Americans suffer from daily chronic pain, a highly debilitating medical condition that is complex and difficult to manage. In recent decades, there has been an overreliance on the prescription of opioids for chronic pain, contributing to a significant and alarming epidemic of opioid overdose deaths and addiction. Innovative scientific solutions to develop non-opioid, non-addictive alternative treatment options are thus urgently needed. One of the goals of the Helping to End Addiction Long-term (HEAL) Initiative is to accelerate the discovery and preclinical development of new medications and devices to treat pain. Two recent NINDS workshops focused on (1) identifying endpoints in pre-clinical pain models and (2) discovering biomarkers to enhance pain therapy development. A logical next step is to identify the scientific gaps and development challenges in moving candidate therapeutics through proof-of-concept studies, early phase clinical trials and to later phases of development including regulatory approval. One major challenge facing the development of non-opioid alternative pain medications in each pain condition is the heterogeneity in patient populations combined with high variability in individual responses to any given intervention. This is further compounded by the diversity of specific disorders associated with pain. Consequently, it is often difficult to define reliable endpoints, both within specific pain conditions and across pain conditions...
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