The profile of the one-time 1572 investigator

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. (C) 2008 Elsevier Inc. All rights reserved.