# Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private Partnership

> **NIH FDA U01** · UNIVERSITY OF ROCHESTER · 2020 · $550,000

## Abstract

Pain is the most common symptom leading patients to consult a physician in the United States.
According to the 2012 National Health Interview Survey, over 100 million adults report experiencing pain
within the past 3 months, and approximately 50% of these individuals reported that the impact of their
pain was moderate or severe. Chronic pain is associated with both direct (e.g., health care) and indirect
(e.g., disability) costs that have been estimated to range from $560-635 billion annually. Although
considerable progress has been made in understanding the pathophysiologic mechanisms of pain, the
most widely prescribed medications for acute and chronic pain—non-steroidal anti-inflammatory drugs
and opioid analgesics—have major shortcomings, including modest efficacy and significant risks that can
limit long-term use. Consequently, there is a compelling public health need for the development of
treatments with improved efficacy and safety. Unfortunately, many analgesic treatments examined in
recent randomized clinical trials have failed to show efficacy. The explanations for these results are
unknown, raising questions about the ability of clinical trials to distinguish efficacious treatments from
placebo or less efficacious treatments (i.e., assay sensitivity). Patient characteristics, clinical trial
research methods, outcome measures, approaches to data analysis, and statistical power may all play a
role in accounting for difficulties in demonstrating the benefits of efficacious treatments. The identification
of specific clinical trial characteristics associated with greater assay sensitivity and the development of
outcome measures with greater validity can provide the foundation for an evidence-based approach to
the design of clinical trials, not only of pain treatment but also in other therapeutic areas. The primary
objective of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations Innovations,
Opportunities, and Networks (ACTTION) public-private partnership is to facilitate the development of
novel analgesic, anesthetic, addiction, and peripheral neuropathy interventions with improved efficacy
and safety. ACTTION is a multidisciplinary collaboration that prioritizes research and other initiatives to
achieve this objective. The major activities of the ACTTION partnership include conducting systematic
reviews, consensus meetings, and methodologically-focused studies as well as developing and
qualifying novel clinical outcome assessments with the aim of increasing the assay sensitivity and
informativeness of clinical trials. The results of these efforts have the potential to inform and accelerate
the development of improved treatments for pain, anesthesia and sedation, addiction, and peripheral
neuropathy.

## Key facts

- **NIH application ID:** 9984968
- **Project number:** 5U01FD005936-05
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Robert H Dworkin
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $550,000
- **Award type:** 5
- **Project period:** 2016-09-15 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9984968

## Citation

> US National Institutes of Health, RePORTER application 9984968, Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private Partnership (5U01FD005936-05). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9984968. Licensed CC0.

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