Evaluation of the Vascular Clinical Trial Program of Metrizamide and Iohexol

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Abstract
The vascular clinical trial programs of the contrast media metrizamide (Amipaque) and iohexol (Omnipaque), organized by Nyegaard and 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 4.5 mo. for 1 iohexol trial compared with 1 mo. for 1 of metrizamide. The reason for this was found to be a higher priority, increased regulatory requirements and a uniform data pool established for the iohexol program. 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 .ltoreq. 0.05) than that of the metrizamide trials.

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