[Difficulties in the approval of clinical trials in Spain. An obstacle race]

Time required until approval of clinical trial protocols as well as the more common bureaucratic problems were studied. A questionnaire was administered to AMIFE members and our experience was analyzed regarding twenty-two multicenter clinical trials performed from 1993 to 1996. Payment to centers resulting in indirect costs ranged from 10% and 30% relative to the total cost of the study in the center and median time to obtain the trial approval was 112 days. Some possible solutions to improve the efficiency in the process of protocol approval are noted.