Performance evaluation in multicenter clinical trials: development of a model by the AIDS Clinical Trials Group.
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.
Rosendorf
L L
LL
Policy Analysis and Legislation Branch, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland 20892.
Dafni
U
U
Amato
D A
DA
Lunghofer
B
B
Bartlett
J G
JG
Leedom
J M
JM
Wara
D W
DW
Armstrong
J A
JA
Godfrey
E
E
Sukkestad
E
E
D000163:Acquired Immunodeficiency Syndrome / Q000628:therapy*; D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D015233:Models, Statistical; D015337:Multicenter Studies as Topic / Q000592:standards*; D009316:National Institutes of Health (U.S.); D015397:Program Evaluation; D012107:Research Design / Q000592:standards; D012109:Research Support as Topic; D014481:United States