Equipoise and test

Comparison or control conditions may include treatment-as-usual or other standard or experimental interventions of proven efficacy.  However, placebo or sham interventions might be used where appropriately justified, for example, in studies of augmentation strategies (blinded) added to existing treatments (generally open-label).  In contrast to efficacy trials, it is anticipated that effectiveness trials might not be double-blind; while self- and clinician-ratings can be informative and may reasonably be collected, unless otherwise justified, raters responsible for key outcome measures should be blinded as to subjects’ treatment assignment.  Primary outcome measures should be validated and generally accepted by the field.  Given the emphasis on practice relevant questions, outcomes of interest extend beyond symptom reduction to include short- and long-term assessment of changes in functioning across domains (such as school, work, family, peer functioning) for children, adolescents, and adults, and also might include other outcomes of interest to key stakeholders (., efficiency, value, or other factors related to the eventual implementation of new intervention and services approaches). 

  • December 13, 2016 - This RFA has been reissued as RFA-MH-17-608 .
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
  • NOT-MH-15-013 ; NOT-MH-15-002 ; NOT-MH-15-009 ; NOT-MH-14-015 ; NOT-MH-14-007 ; NOT-MH-15-012 and NOT-MH-14-004     

    Equipoise and test

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