Ethics Case Studies in Biodesign

Case 6 - Outside US (OUS) Trial

Neuvesel Corporation has been satisfied with the results of animal trials of their new blood vessel prosthesis. They have decided, after much discussion to move on to human testing of the device. Because of cost and logistical barriers in the United States, they will arrange to test their device first in India and then in European centers.
There are discussions within the company about several aspects of this plan:

• The number of patients that can be enrolled in a short period of time.
  
• The rigor of the case selection criteria in compliance with the experimental protocol.
  
• The ability of the company to acquire complete records on the patients for future device approval processes, since company personnel cannot remain on-site throughout the study period.
  
• The end-points of the study for regulatory purposes.
  
• The cost of the study when fully completed.
  
• The ability of the Indian patients to fully understand the experimental nature of the first implantations regarding informed consent.
  
• The compliance of the surgeons with the strict implantation protocol.
  
• The need to modify the device and/or protocol as a result of the initial human experience.
  
• The attitude of the United States F.D.A. to the initial testing outside the United States.
  
• The ‘image’ of the company when doing OUS studies.
• Which of these points can you address and which do you think are most important to you as an officer of the company getting through the regulatory process as rapidly as possible to conserve the funds in the company?
  
• Which do you think are most important to you as member of the company learning the value and issues of your device?
  
• Which do you think are most important to you as member of the company concerned about the patients getting your device?
  
• What steps can you take to address each of these concerns?
  
• What are the specific "cost and logistical barriers in the United States" that would induce Neuvesel to do it’s initial human trial outside the United States?
  
• What are the potential (balancing) advantages of doing the initial human trials in the United States?