Evaluation of the vascular clinical trial program of metrizamide and iohexol.
The vascular clinical trial programs of the contrast media metrizamide (Amipaque) and iohexol ( Omnipaque ), organized by Nyegaard & Co. AS in Northern Europe were assessed and compared. The comparison comprised some selected characteristics of the programs, self-assessment by the investigators involved in both programs (questionnaire) and assessment of the standard of the trial reports (2 evaluators). It was found that Nyegaard clinical research staff spent in average 4 1/2 month for one iohexol trial compared with one month for one of metrizamide. The reason for this found to be a higher priority, increased regulatory requirements and a uniform data pool established for the iohexol program. In general, a quality improvement was revealed for the iohexol program over the metrizamide program. The 2 evaluators as well as the questioned investigators found the reporting standard of the iohexol trials significantly higher (p less than or equal to p less than or equal to 0.05) than that of the metrizamide trials.
D000792:Angiography / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards; D003287:Contrast Media; D006801:Humans; D007463:Iodobenzoates; D007472:Iohexol; D007485:Ioxaglic Acid; D008793:Metrizamide; D011786:Quality Control; D012107:Research Design / Q000592:standards; D012537:Scandinavian and Nordic Countries; D011795:Surveys and Questionnaires; D014283:Triiodobenzoic Acids
D003287:Contrast Media; D007463:Iodobenzoates; D014283:Triiodobenzoic Acids; D007472:Iohexol; D008793:Metrizamide; D007485:Ioxaglic Acid