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sns34 replied to the topic Types of Clinical Studies in the forum Clinical Trials for Medical Devices 7 years, 11 months ago
Recently, I was involved in a single blind user study at work that involved our production parts and an R&D part that will be available on the market within the next year or two. As Dr. Simon mentioned in his lecture, the study involved a concealed identity of a product—in this case it was 3 prototypes of the new product—and a known identity of a product—the company’s production part that is already on the market. We are looking to improve the production part, and thus, for this user study, nurses and pharmacy technicians were asked to come in to participate and give their feedback on all of the devices that were given to them. The person collecting the data knew the differences between the prototypes, while the users did not and this resulted in an unbiased study and honest feedback. The data that was collected by the observer helped the team make final decisions on which prototype would be better than the current production part and would also meet the customer needs. Unfortunately, I have not been part of a single study that involved any sort of drug, but being a part of a R&D user study in a medical device company was extremely exciting and an unforgettable experience.