Haakenson C, Fye C L, Sather M R, Toussaint D J
Control Clin Trials. 1987 Jun;8(2):101-9. doi: 10.1016/0197-2456(87)90035-3.
The Food, Drug, and Cosmetic Act requires that clinical investigations conducted in the United States involving unapproved drugs be done under an Investigational New Drug Application (IND). INDs are often sponsored by pharmaceutical firms or noncommercial research institutions. Most INDs, however, are sponsored by individual researchers. Since the procedures for filing an IND may not be well understood, this article seeks to clarify these procedures. Specifically, this article describes a "Sponsor-Investigator IND," the conditions under which one is required, and the possible advantages of filing one. The information presented aids the investigator in determining whether an IND need be submitted. The authors have developed an IND workbook that can be used to organize and present the IND application in a form likely to facilitate expeditious review and approval by the FDA. The authors have also developed IND guidelines to assist investigators in preparing, submitting, and maintaining an IND. Obligations and responsibilities of both sponsors and investigators are discussed.
《食品、药品和化妆品法案》要求在美国进行的涉及未经批准药物的临床研究须依据新药临床试验申请（IND）开展。IND通常由制药公司或非商业研究机构发起。然而，大多数IND是由个体研究人员发起的。由于提交IND的程序可能未被充分理解，本文旨在阐明这些程序。具体而言，本文描述了“申办者-研究者IND”、要求申办者-研究者IND的条件以及提交该申请的潜在优势。所提供的信息有助于研究者确定是否需要提交IND。作者编制了一本IND工作手册，可用于以可能便于美国食品药品监督管理局（FDA）快速审查和批准的形式组织和提交IND申请。作者还制定了IND指南，以协助研究者准备、提交和维护IND。文中讨论了申办者和研究者的义务与责任。
