June 26, 2015: ACTTION to Qualify New Pain Intensity Outcome Measure
The FDA has completed review of ACTTION’s Letter of Intent to pursue qualification of a patient-reported outcome measure of acute and chronic pain intensity and has agreed to enter this project into the Clinical Outcomes Assessments Drug Development Tools qualification program. The development and validation of this new measure – Qualified for Therapeutic Evaluations of Pain (QUALITE-Pain) – will be a multi-year undertaking and will begin with qualitative research in different pain conditions and in adult and adolescent patient populations in order to determine the appropriate context of use for QUALITE-Pain. Shannon Smith, PhD, ACTTION Assistant Director, will be spearheading this major initiative and will be establishing a new ACTTION Working Group to oversee the development of QUALITE-Pain.
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ACTTION Guide to Clinical Trials of Pain Treatments
The ACTTION Guide to Clinical Trials of Pain Treatments consists of two supplements published in the journal Pain Reports that include a series of articles describing research designs and methods, study conduct, outcome measures, data analyses and interpretation, and reporting recommendations for clinical trials of acute and chronic pain treatments.
Part I includes 9 articles that can be found here, and Part II includes 6 articles that can be found here.