The clinical evaluation of antibacterial drugs: guidelines of the British Society for Antimicrobial Chemotherapy.

Anti-infective agents differ in several respects from other classes of therapeutic drugs. They are aimed at the treatment or prevention of infection which can occur at several body sites and be caused by a wide range of microorganisms. The infectious process frequently modifies metabolic behaviour which in turn may affect the pharmacology of an agent. In addition, the issue of drug resistance raises concerns in individual patients, hospital units and the broader community. The difficulties in scientifically validating the clinical efficacy and safety of anti-infective drugs led to the Report on the Clinical Evaluation of Antibacterial Drugs of the British Society for Antimicrobial Chemotherapy. The report identifies general principles relevant to the study of these drugs in man and identifies the major microbiological and clinical considerations. Detailed comments on the conduct of pharmacokinetic studies and therapeutic trials are provided with particular emphasis on design, definitions, execution and analysis. Adverse event monitoring, assessment of severity and determination of causality are also reviewed. Pharmaco-economic considerations are identified as a significant issue for the future. The revision of the 1977 FDA guidelines on anti-infective drug development provides the opportunity to harmonise these issues, particularly within the major markets of North America, Europe and Japan.