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Uses of Laboratory Data in anti Infective Drug Approval Processes*

Laboratory data represent a largely unused body of data in the drug approval process. Such data, when properly collected and used, can provide invaluable insights into drug efficacy and safety in subgroups of the target population. The Statistical Evaluation and Research Branch's use of these data for these two purposes uncovered several problems. These include the lack of standard nomenclature and terminology, properly established reference intervals, and documented auditing methods plus doubts about the validity of data due to lack of proof of good laboratory practices (GLP). There were errors in computerization of data that adversely affected evaluation and interpretation of these data.