NIDA Science Meeting
Bethesda, MD
December 15-16, 2009

Contacts:

Carmen L. Rosa, M.S.
Center for the Clinical Trials Network
National Institute on Drug Abuse
(301) 443-9830
crosa@nida.nih.gov

Paul G. Wakim, PhD
Center for the Clinical Trials Network
National Institute on Drug Abuse
(301) 402-3057
pwakim@nida.nih.gov

Jack Blaine, PhD
Center for the Clinical Trials Network
National Institute on Drug Abuse
(301) 443-2246
pwakim@nida.nih.gov

View Agenda (PDF - 45 Kb)

• 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.

• 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

• (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

• 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.

• "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

• 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