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.

Public Health Relevance

Millions of Americans suffer from pain, addiction, and peripheral neuropathy and the available treatments are inadequate. The primary objective of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTION) public-private partnership is to identify, prioritize, sponsor, coordinate, and promote innovative activities that will expedite the discovery and development of improved analgesic, anesthetic, addiction, and peripheral neuropathy treatments for the benefit of the public health. The research projects and other activities conducted by ACTTION will focus on optimizing the design, analysis, execution, and interpretation of clinical trials, and the knowledge to be gained has the potential to make novel medications and other interventions available that are more effective and safer than existing treatments.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01FD005936-01
Application #
9297674
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2016-09-15
Project End
2021-08-31
Budget Start
2016-09-15
Budget End
2017-08-31
Support Year
1
Fiscal Year
2016
Total Cost
$500,000
Indirect Cost
Name
University of Rochester
Department
Anesthesiology
Type
Schools of Dentistry
DUNS #
041294109
City
Rochester
State
NY
Country
United States
Zip Code
14627
Walco, Gary A; Kopecky, Ernest A; Weisman, Steven J et al. (2018) Clinical trial designs and models for analgesic medications for acute pain in neonates, infants, toddlers, children, and adolescents: ACTTION recommendations. Pain 159:193-205
Gewandter, Jennifer S; Chaudari, Jenna; Iwan, Katarzyna B et al. (2018) Research Design Characteristics of Published Pharmacologic Randomized Clinical Trials for Irritable Bowel Syndrome and Chronic Pelvic Pain Conditions: An ACTTION Systematic Review. J Pain 19:717-726
Kent, Michael L; Tighe, Patrick J; Belfer, Inna et al. (2017) The ACTTION-APS-AAPM Pain Taxonomy (AAAPT) Multidimensional Approach to Classifying Acute Pain Conditions. Pain Med 18:947-958
Gewandter, Jennifer S; Burke, Laurie; Cavaletti, Guido et al. (2017) Content validity of symptom-based measures for diabetic, chemotherapy, and HIV peripheral neuropathy. Muscle Nerve 55:366-372
Rothstein, Daniel; Kitt, Rachel A; Smith, Shannon M et al. (2017) Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review. Reg Anesth Pain Med 42:392-399
Kent, Michael L; Tighe, Patrick J; Belfer, Inna et al. (2017) The ACTTION-APS-AAPM Pain Taxonomy (AAAPT) Multidimensional Approach to Classifying Acute Pain Conditions. J Pain 18:479-489
Williams, Mark R; Ward, Denham S; Carlson, Douglas et al. (2017) Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 1 Efficacy: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations. Anesth Analg 124:821-830
Smith, Shannon M; Dworkin, Robert H; Turk, Dennis C et al. (2017) The Potential Role of Sensory Testing, Skin Biopsy, and Functional Brain Imaging as Biomarkers in Chronic Pain Clinical Trials: IMMPACT Considerations. J Pain 18:757-777
Gewandter, Jennifer S; Kitt, Rachel A; Hunsinger, Matthew R et al. (2017) Reporting of data monitoring boards in publications of randomized clinical trials is often deficient: ACTTION systematic review. J Clin Epidemiol 83:101-107
Smith, Shannon M; Jones, Judith K; Katz, Nathaniel P et al. (2017) Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations. J Pain 18:1287-1294

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