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December 15, 2009 to December 16, 2009
Bethesda, Maryland

Main Objectives

  • What is a clinically meaningful and scientifically valid primary outcome for effectiveness trials on substance abuse treatments?
  • What is the most appropriate approach (e.g. instrument, algorithm, or procedure) for capturing that outcome?

Expectation from Meeting

To reach a consensus on:

  • What we know today, and therefore what doesn't need to be re-addressed.
  • The key issues needed to fill important gaps in our scientific knowledge.

Why is this important?

  • So that we collect and analyze data on clinically meaningful outcomes at critical time points in the most cost-effective manner
  • So that we compare treatment effectiveness across trials based on a common scale
  • So that we conduct secondary analyses across trials based on common elements
  • So that we don't revisit the same issues over and over again every time we design a new trial

Two Different Harmonization Issues

  • (Drug abuse) Science harmonization, the focus of this NIDA Science Meeting
  • Operational harmonization, i.e. standardization of instruments, questionnaires, case report forms, etc.


  • Introduction
  • Alcohol Experience
  • Tobacco Experience
  • Mental Health (Depression) Experience
  • History of Outcomes in Substance Abuse Effectiveness Trials
  • Panel I: State of the Science in Assessing Drug Use in Clinical Research: Biological Measures
  • Panel II: State of the Science in Assessing Drug Use in Clinical Research: Self-Reported Measures
  • Panel III: Primary Outcome
  • Panel IV: Other Important Measures to Consider

Meeting Consensus

website graphic for NIH meeting - New Models for Large Prospective Studies Symposium
  • Different studies with different goals, treatment aims, and target populations necessitate different outcomes.
  • Drug use, measured by self-report and biological test, is one strong candidate for primary outcome.
  • But consequences of drug use, e.g. psychosocial functioning, quality of life, criminal justice involvement, may also be as important.

Moving Forward

  • "Operational harmonization" helps "science harmonization" by evaluating assessment tools across studies
  • Conduct long-term follow-up studies to identify short-term predictors of long-term outcomes, and to better understand which are important
  • Analyze CTN data currently on CTN's Public Data Share (22 studies) based on common instruments
  • Plan another workshop in 2-3 years, but with results from analyses

How Should NIH Approach Future Prospective Cohort Studies

  • Ensure future studies, including disease-specific studies, address widest possible range of outcomes
  • Strong leadership is essential
  • Use standardized measures to permit diverse studies to be combined (and that could start NOW)
  • Establish consents that allow for broad research use and data sharing
  • Maximize cost-efficiency where appropriate by:
    • Exploring centralized recruitment and exam models
    • Considering lower recruitment yield if associations rather than prevalence are primary objective
    • Utilizing electronic records