Document 0606
 DOCN  M9460606
 TI    Performance evaluation in multicenter clinical trials: development of a
       model by the AIDS Clinical Trials Group.
 DT    9404
 AU    Rosendorf LL; Dafni U; Amato DA; Lunghofer B; Bartlett JG; Leedom JM;
       Wara DW; Armstrong JA; Godfrey E; Sukkestad E; et al; Policy Analysis
       and Legislation Branch, National Institute of; Allergy and Infectious
       Diseases, NIH, Bethesda, Maryland 20892.
 SO    Control Clin Trials. 1993 Dec;14(6):523-37. Unique Identifier : AIDSLINE
       MED/94163900
 AB    The AIDS Clinical Trials Group (ACTG), supported by the National
       Institute of Allergy and Infectious Diseases (NIAID), is the largest
       federally funded program of AIDS clinical trials. It is a collaboration
       involving 59 institutions and affiliated clinical centers, known as AIDS
       Clinical Trials Units (ACTUs), NIAID staff, and a Statistical and Data
       Analysis Center (SDAC). An institutional evaluation tool was developed
       to evaluate ACTU performance, distinguish between clinical centers with
       superior performance and those not meeting standards, and assist NIAID
       in allocating funding based on performance. The evaluation tool was
       designed to reflect the many distinguishing features of ACTG study
       protocols and clinical trial centers in order to measure performance
       objectively. The evaluation focused on assessing the financial resources
       expended by the ACTU in recruiting, treating, and following study
       patients during the evaluation period; the number of women and
       minorities enrolled; and the ACTU's scientific contributions to the
       ACTG. To help quantify the ACTU's performance in enrolling study
       subjects, a formula was derived to assess the total effort required to
       screen, enroll, treat, and assess subjects participating in ACTG
       studies. A weighting system was developed for each study protocol to
       account for the variations in effort and resources required by the
       different protocols. Future directions in the ACTG evaluation process
       include strategies to evaluate performance in relation to quality of
       data and to determine ways in which the evaluation process can be used
       to enhance the achievement of programmatic goals.
 DE    Acquired Immunodeficiency Syndrome/*THERAPY  Clinical
       Protocols/STANDARDS  Clinical Trials/*STANDARDS  Evaluation Studies
       Female  Human  Male  Models, Statistical  Multicenter Studies/*STANDARDS
       National Institutes of Health (U.S.)  Program Evaluation  Research
       Design/STANDARDS  Research Support  Support, U.S. Gov't, P.H.S.  United
       States  JOURNAL ARTICLE

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       protected by Copyright Law (Title 17, U.S.Code).