Glass Harold E
University of the Sciences in Philadelphia, United States.
Contemp Clin Trials. 2009 Jan;30(1):34-9. doi: 10.1016/j.cct.2008.09.008. Epub 2008 Sep 18.
The FDA database on investigators completing the 1572 form constitutes a rich database of practicing investigators. Within the most recent three-year period, roughly half of all the principal investigators appear only once in the 1572 database, which leads some to conclude that many of these investigators have only conducted one study and may be reluctant to be involved in a second clinical trial. Part of the misunderstanding about these investigators comes from the incorrect notion that 1572 forms are required to be submitted to the FDA. Drawing upon a random sample of 762 US investigators, the study concludes that many of the one-time 1572 investigators have participated as principal investigators in far more than one clinical trial, although the number is less than the number of clinical trials reported by investigators with multiple 1572s on record. There are few demographic or prescribing differences between the one-time 1572 and the multi-1572 groups. Nor do they differ in the reasons for taking part in clinical trials. Investigators with multiple 1572s are more likely though to come from academic medical centers, teaching organizations or research centers. Investigators with one 1572 are no more dissatisfied with the key activities of running clinical trials at their sites than are other investigators, although the one 1572 investigators appear slightly less willing to continuing their participation in clinical trials. Investigators with multiple 1572s, with their record of IND trial experience are a valuable pool of candidates for clinical trials. However, the data in this study cautions organizations conducting clinical trials to not overlook the single largest group of investigators, those in the one-time 1572 pool.
美国食品药品监督管理局（FDA）关于填写1572表格的研究者的数据库构成了一个丰富的执业研究者数据库。在最近三年期间，所有主要研究者中约有一半仅在1572数据库中出现过一次，这使得一些人得出结论，这些研究者中的许多人只进行过一项研究，可能不愿参与第二项临床试验。对这些研究者的部分误解源于一种错误观念，即认为需要向FDA提交1572表格。该研究抽取了762名美国研究者作为随机样本，得出结论：许多仅填写过一次1572表格的研究者作为主要研究者参与的临床试验远不止一项，尽管其数量少于有多项1572记录的研究者所报告的临床试验数量。仅填写过一次1572表格的研究者与填写过多次1572表格的研究者在人口统计学特征或处方方面几乎没有差异。他们参与临床试验的原因也没有不同。不过，有多项1572记录的研究者更有可能来自学术医疗中心、教学机构或研究中心。仅填写过一次1572表格的研究者对在其机构开展临床试验的关键活动的不满程度并不高于其他研究者，尽管仅填写过一次1572表格的研究者似乎稍不太愿意继续参与临床试验。有多项1572记录且有研究性新药（IND）试验经验记录的研究者是临床试验的宝贵候选人群体。然而，本研究中的数据提醒开展临床试验的机构不要忽视最大的单一研究者群体，即仅填写过一次1572表格的那些人。
