# Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01)

> **NIH FDA U01** · UNIVERSITY OF ROCHESTER · 2022 · $800,000

## Abstract

The development of improved treatments and greater understanding of existing interventions
will address the enormous public health burden resulting from limited efficacy and safety of
existing pain treatments, increasing prevalence of opioid and stimulant addiction, safety risks of
adult anesthesia (e.g., post-operative delirium), and potential developmental neurotoxicities
associated with pediatric anesthesia, especially in vulnerable children. A compelling rationale for
developing new paradigms to identify treatments with improved efficacy and safety is provided
by the limitations of existing approaches to identifying novel treatments, inadequate
understanding of the explanations for negative and inconclusive clinical trials, incomplete
characterizations of treatment risks, and lack of knowledge of factors associated with clinical
trial assay sensitivity. The mission of the public-private partnership described in this application
will be to “identify, prioritize, sponsor, coordinate, and promote innovative activities — focusing
on maximizing treatment benefits and minimizing their risks — that will expedite the discovery
and development of improved analgesic, addiction, and adult and pediatric anesthetic
treatments for the benefit of the public health.” The major objective of the partnership will be to
provide a multidisciplinary collaborative framework to prioritize research objectives and conduct
methodologically-focused studies and other activities to facilitate the discovery and development
of analgesic, addiction, and anesthetic interventions with greater efficacy and safety. In each of
these therapeutic areas, there are multiple opportunities to develop innovative research
methods that can accelerate the translation of preclinical research results to phase 2 and 3
clinical trials and to meaningful studies of real-world data and evidence. Systematic efforts to
increase the efficiency and informativeness of clinical trials and other types of clinical research
to detect efficacy and effectiveness, determine patient preferences, and improve assessments
of safety — for example, by analyzing the methods and results of preclinical studies,
randomized clinical trials, and rigorous observational studies — can provide the foundation for
evidence-based recommendations for the design and interpretation of future research. To
achieve its objectives, the partnership will include representatives from academia, multiple
professional societies, government agencies, patient advocacy organizations, and industry. The
overarching goals and promise of the public-private partnership are to improve the lives of
patients of all ages and thereby contribute meaningful benefits to the public health.

## Key facts

- **NIH application ID:** 10607632
- **Project number:** 1U01FD007702-01
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Robert H Dworkin
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $800,000
- **Award type:** 1
- **Project period:** 2022-09-20 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10607632

## Citation

> US National Institutes of Health, RePORTER application 10607632, Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01) (1U01FD007702-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10607632. Licensed CC0.

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