THE NASCET1 and the ACAS2 were the largest and best-organized trials affecting the management of extracranial carotid arteriosclerosis. Both trials have clearly defined patient populations that benefit from carotid endarterectomy compared with best medical management.
A repeat of any clinical trial must not be treated lightly when one considers patient commitment and possible sacrifice by randomization to less effective treatment, the use of professional time, and the cost burden to the United States by the expenditure of National Institutes of Health (NIH) research funds. It has been estimated that the NASCET cost the US taxpayer nearly $38 million, and ACAS, more than $24 million. However, if it can be shown with reasonably strong evidence that either trial has come to erroneous conclusions or that the conclusions are no longer valid, then a repeated trial should be entertained. Let us review the possible general reasons why trial . . . [Full Text of this Article]
REASONS TO CONSIDER REPEATING A CLINICAL TRIAL
A Design Flaw
Better Medical Management
Change in the Natural History of Disease
Questions Regarding Statistical Analysis
New Data Showing Conflicting Results
Improved Surgical Management
Alternative Interventional Treatment
REASONS NOT TO REPEAT A TRIAL
Cost
Informed Consent
CONCLUSIONS
