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Analgesic Clinical Trial Innovations,Opportunities,and Networks(ACTION)

镇痛临床试验创新、机遇和网络（行动）

基本信息

批准号：
8703517
负责人：
Robert H Dworkin
金额：
$ 50万
依托单位：
UNIVERSITY OF ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-09-15 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8703517
关键词：
Analgesic Clinical Trial Innovations Opportunities

项目摘要

Project Summary/Abstract Millions of American experience acute and chronic pain. Despite considerable progress identifying pathophysiologic mechanisms of acute and chronic pain, available treatments remain inadequate. Consequently, there is a compelling public health need for the development of treatments with improved efficacy, safety, and tolerability. Unfortunately, numerous analgesic treatments examined in recent randomized clinical trials have failed to show efficacy. The explanations for these negative results are unknown, raising questions about the ability of clinical trials in chronic pain to distinguish efficacious treatments from placebo or less efficacious treatments (i.e., assay sensitivity). Patient characteristics, clinical trial research designs and 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 analgesic treatments vs. placebo. The identification of specific clinical trial characteristics associated with assay sensitivity in existing data has the potential to establish an evidence-based approach to the design of analgesic clinical trials. The U.S. Food and Drug Administration recently launched Analgesic Clinical Trial Innovations, Opportunities, and Networks (ACTION), a public-private partnership intended to facilitate the discovery and development of analgesics with improved efficacy, safety, and tolerability for acute and chronic pain. ACTION will establish a collaborative initiative to prioritize research objectives, develop a standardized analgesic database platform, and conduct methodologically-focused studies to increase the assay sensitivity and efficiency of analgesic clinical trials. The results of these studies and other activities have the potential to inform and accelerate the development of improved pain management interventions of all types, not just pharmacologic treatments.

项目总结/文摘

项目成果

期刊论文数量（18）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Painful chemotherapy-induced peripheral neuropathy: lack of treatment efficacy or the wrong clinical trial methodology?

DOI：
10.1097/j.pain.0000000000000653
发表时间：
2017-01
期刊：
Pain
影响因子：
7.4
作者：
Gewandter JS;Dworkin RH;Finnerup NB;Mohile NA
通讯作者：
Mohile NA

Reporting of sample size calculations in analgesic clinical trials: ACTTION systematic review.

镇痛临床试验中样本量计算的报告：行动系统评价。

DOI：
10.1016/j.jpain.2014.11.010
发表时间：
2015
期刊：
The journal of pain
影响因子：
0
作者：
McKeown,Andrew;Gewandter,JenniferS;McDermott,MichaelP;Pawlowski,JosephR;Poli,JosephJ;Rothstein,Daniel;Farrar,JohnT;Gilron,Ian;Katz,NathanielP;Lin,AllisonH;Rappaport,BobA;Rowbotham,MichaelC;Turk,DennisC;Dworkin,RobertH
通讯作者：
Dworkin,RobertH

Instruments to Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: An ACTTION Systematic Review.

临床试验中识别处方药误用、滥用和相关事件的工具：行动系统评价。

DOI：
10.1016/j.jpain.2015.01.009
发表时间：
2015
期刊：
The journal of pain : official journal of the American Pain Society
影响因子：
0
作者：
Smith,ShannonM;Paillard,Florence;McKeown,Andrew;Burke,LaurieB;Edwards,RobertR;Katz,NathanielP;Papadopoulos,ElektraJ;Rappaport,BobA;Slagle,Ashley;Strain,EricC;Wasan,AjayD;Turk,DennisC;Dworkin,RobertH
通讯作者：
Dworkin,RobertH

Estimands and missing data in clinical trials of chronic pain treatments: advances in design and analysis.