“Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges & opportunities”
In 2018, the NIH-led Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop convened scientific leaders from academia, industry, government and patient advocacy groups to discuss progress, challenges, gaps and ideas to facilitate the development of biomarkers and end points for pain. The outcomes of this workshop are outlined in this Consensus Statement.
Pain medication plays an important role in the treatment of acute and chronic pain conditions, but some drugs, opioids in particular, have been overprescribed or prescribed without adequate safeguards, leading to an alarming rise in medication-related overdose deaths.
The NIH Helping to End Addiction Long-term (HEAL) Initiative is a trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to support biomarker discovery and rigorous validation in collaboration with industry leaders to accelerate high-quality clinical research into neurotherapeutics and pain.
To help improve pain management, there is a need to develop translational tools, such as well-validated biomarkers and objective clinical trial end points for pain. This topic provided the basis for the NIH Discovery and Validation of Biomarkers to Develop Non-Addictive Therapeutics for Pain workshop. In this Consensus Statement, we report on the outcomes of this workshop and provide guidance for the development and validation of biomarkers and end points for chronic pain.
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