The goal of the Medications Development Program of NIAAA is to identify and evaluate the safety and efficacy of medications for the treatment of alcohol use disorders (AUD). The Program has established a rapid and efficient contractual extramural infrastructure to design, conduct, and analyze outcomes of Phase 2 clinical trials of promising medications. A novel and central element of the Program is the responsibility to develop and apply new clinical trials methodology to meet the specialized needs of the Program's studies. This element requires performance of exacting statistical analyses on large data sets from completed trials. These analyses need to be performed quickly, thoroughly and accurately in order to use findings from a completed trial to plan the design of the next study. Inherent in the requirements for the tasks described below is a critical need for continuity of analytic approach. Further work relies heavily on the complex, statistical computer programs and algorithms developed by CSR, Inc. New work must be done in a fashion which replicates these programs so that newly constructed data items are exactly comparable to the preceding work. The Program plans new studies based on analyses provided by the contractor. The effect of lack of analytic continuity would seriously bias the results and provide misleading information to the Program as it plans new studies. Hence, seamless continuity of the analytic work essential to the progress of the program is of paramount importance.
