June 11, 2018: Updates on Novel Clinical Outcome Assessments

  • QUALITE-Pain (QUALIfied for Therapeutic Evaluations of Pain), led by Shannon Smith, PhD, ACTTION Senior Assistant Director: Individuals with diverse acute and chronic pain conditions have been interviewed about their experiences with pain, understanding of several existing pain measures, and opinions about how their pain should be rated. Qualitative analyses of these interviews are ongoing, and the results will inform the development of the conceptual framework for QUALITE-Pain.
  • PAACT (Physical Activity Accelerometry Assessment for Analgesic Clinical Trials), led by Kushang Patel, PhD, ACTTION Assistant Director: FDA has entered PAACT into the Clinical Outcomes Assessments Drug Development Tools qualification program, and a draft protocol for qualitative studies is being prepared and will be submitted to the FDA for comments.