Clinical Core

Leadership

Dr. Stephanie O'Malley

The Clinical Core has established common methodologies to facilitate cognitive and clinical research domains and allow us to compare and pool data across projects for secondary analyses to help us define issues of vulnerability. All subjects enrolled in a CTNA project or pilot study will complete the Clinical Core assessment battery. We also provide training in key assessments such as the timeline follow-back and the SCID and help promote recruitment into studies.

Activities

The CTNA Clinical Core serves an important function as the central resource for the diverse clinical projects and pilots. It represents the distinct advantage of an Alcohol Research Center over a cluster of individual grants. The opportunity to fund a central facility with a distinguished leader provides a programmatic method to define needs and assign resources to address central issues. The central components of the Clinical Core are oversight of subject recruitment and clinical assessments for all clinical projects, data management (Directed by Elaine LaVelle) and data analysis (Directed by Dr. Ralitza Gueorguieva and Brian Pittman).


The specific aims for the Clinical Core are:

  • Centralized monitoring of subject recruitment to: 1) Enhance the efficiency of enrollment into each project, including pilots; and 2) Update the Principal Investigators (PIs), the Scientific Advisory Board, and the Data Safety Monitoring Board of progress on the protocols. 
  • Central oversight of assessments to: 1) Provide efficiency in training and assessment; 2) Maintain consistency in the administration of assessments; 3) Enhance the ability of investigators to pool data across studies; 4) Insure that validated and current assessment tools are used; and 5) Support secondary analyses utilizing core assessments.
  • Central provision of Data Management and Biostatistics support to: 1) Provide design and analytical expertise to meet the goals of the CTNA scientific agenda; 2) Provide state-of-the-art methods for data management; 3) Generate randomization lists and assess randomization implementation; 4) Interface with specialized data analysis expertise related to particular technologies associated with the CTNA, including genetics and imaging; 5) Prepare reports related to the progress of clinical studies for the Data Safety Monitoring Board; and 6) Provide statistical support for all investigators.