Morton W A, DeVries W C, Dobelle W H, Serkes K D, Sheridan R, Dennis C
Trans Am Soc Artif Intern Organs. 1983;29:770-3.
From a research perspective, some of the primary problems created by the FDA regulations include: the amount of time necessary to comply with the regulations and to obtain FDA and IRB review of the studies. The cost of such delays may be great in terms of statistical death. Lack of understanding of the regulations on the part of investigators. Escalated costs and extra restrictions on the use of animals. Benefits of the regulations appear to be: better preclinical testing performed prior to initiating clinical trials, and improved testing protocols, both of which may result in lower risks to patients.
从研究角度来看，美国食品药品监督管理局（FDA）的法规带来的一些主要问题包括：遵守法规以及获得FDA和机构审查委员会（IRB）对研究的审查所需的时间。就统计学意义上的死亡而言，这种延迟造成的成本可能很高。研究人员对法规缺乏了解。动物使用成本增加以及限制增多。该法规的好处似乎在于：在启动临床试验之前进行更好的临床前测试，以及改进测试方案，这两者都可能降低患者风险。
