Guidelines for evaluating new antimicrobial agents.

Abstract

Evaluating new antimicrobial agents is governed mostly by interaction between the pharmaceutical industry and the Food and Drug Administration (FDA). Clinical trials are designed to comply with FDA guidelines published in 1977. Basic principles of the 1977 guidelines remain valid; however, changes in the clinical application of anti-infective agents and in the accepted design of clinical trials have occurred. Some changes are inconsistent with the requirements of the 1977 documents. Members of the Infectious Diseases Society of America (IDSA) have the perspective and knowledge needed to assist in updating the 1977 guidelines. It is proposed that the IDSA establish a formal working relationship with the FDA to review and modernize the 1977 guidelines. Industry participation in this process is desirable. If the IDSA can help orchestrate guideline revision in an environment of mutual respect and cooperation, the result may be a more efficient drug-evaluation process that continues to protect the public interest and is more consistent with contemporary concepts of treatment for infectious disease.