Gilbert D N
Chiles Research Institute, Providence Medical Center, Portland, Oregon 97213.
J Infect Dis. 1987 Dec;156(6):934-41. doi: 10.1093/infdis/156.6.934.
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.
新型抗菌药物的评估主要由制药行业与食品药品监督管理局（FDA）之间的相互作用所主导。临床试验的设计需符合FDA于1977年发布的指南。1977年指南的基本原则仍然有效；然而，抗感染药物的临床应用以及临床试验公认的设计已发生变化。有些变化与1977年文件的要求不一致。美国传染病学会（IDSA）的成员具备协助更新1977年指南所需的视角和知识。提议IDSA与FDA建立正式的工作关系，以审查1977年指南并使其现代化。行业参与这一过程是可取的。如果IDSA能够在相互尊重与合作的环境中协助精心策划指南修订，结果可能是一个更高效的药物评估过程，既能继续保护公众利益，又更符合当代传染病治疗理念。
