Cooperative Agreement to Support Activities Related to Analgesics, Anesthetics, and Addiction (U01) Clinical Trials Allowed
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The Food and Drug Administration, under the Department of Health and Human Services, is seeking a cooperative agreement to develop, implement, and evaluate critical research within the fields of anesthesia, addiction medicine, and pain medicine. The primary objective is to establish a comprehensive evidence-based plan that improves the appropriate prescribing of drug products used for analgesia, anesthesia, and substance use disorders. Key research priorities include creating clinical trial endpoints and functional measurements for chronic pain, developing outcome measures for stimulant use disorders, and assessing opioid trials using active controls. Additionally, the initiative focuses on neurodevelopmental outcome assessments for vulnerable pediatric patients exposed to anesthesia and opioids, as well as maintaining a living systematic review of pre-clinical studies regarding anesthetic neurotoxicity. Multiple awards may be granted to qualified applicants.
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To develop, disseminate, implement, and evaluate research needed in Anesthesia, Addiction Medicine and Pain Medicine in various fields of research. Specifically, research is needed in the following fields: function as a clinical trial endpoint and measurement of function in patients with chronic pain, outcome measures for clinical trials in stimulant use disorders, assessment of opioid clinical trials with active control in addition to placebo, neurodevelopmental outcome assessment of vulnerable pediatric patients exposed to anesthesia and opioid, and a living systematic review of pre-clinical studies of anesthetic neurotoxicity. Multiple awards may be considered. Applicants must propose a comprehensive evidence-based plan that advances appropriate prescribing of drug products intended for analgesia, anesthesia, and substance use disorders.
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