The role of biomarkers in alcoholism medication trials.
BACKGROUND
Increasingly, biomarkers are being incorporated into the research design of clinical trials on medications to reduce drinking in alcoholics. To date, however, there has been little analysis of the unique roles that biomarkers can play in such investigations or of the practical and conceptual considerations that surround their best use in this context.


METHODS
Clinical trials of alcoholism medications published between 1985 and the present were abstracted to determine how biomarkers were used and how changes in them related to self-report measures of drinking.


RESULTS
Six uses of biomarkers were identified: determination of subjects to be included or excluded in the trial; description of baseline sample characteristics; primary and secondary outcome assessment; corroboration of self-reports of drinking status; specification of patients likely to respond to the medication; and evaluation of drug safety.


CONCLUSIONS
Use of biomarkers in such studies appears warranted, particularly as an objective source of information on treatment efficacy that can be considered with patient self-report measures of drinking status. Biomarkers related to liver functioning also can assist in determination of drug safety for medications metabolized by the liver.
Allen
J P
JP
National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland 20852-7003, USA. jpallenphd@cs.com
Litten
R Z
RZ
Strid
N
N
Sillanaukee
P
P
D000437:Alcoholism / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D012106:Research; D012680:Sensitivity and Specificity; D014168:Transferrin / Q000031:analogs & derivatives / Q000032:analysis; D005723:gamma-Glutamyltransferase / Q000097:blood
D015415:Biomarkers; D014168:Transferrin; C056759:carbohydrate-deficient transferrin; D005723:gamma-Glutamyltransferase