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.