Role of the industry sponsor: Protection of human subjects in early device-application studies

Industry sponsors face unique challenges when designing early studies of the application of medical devices studies for disease states in which standard treatments are ineffective. Although accountability for the protection of people who volunteer for these important research studies is shared by industry, investigators, regulators and institutional review boards, industry must play a principal role in balancing the goals of science, medicine, and regulatory approval. From an industry perspective, subject protection is predicated on an understanding of the disease state to be studied, predicting the potential effects of therapy with a particular device on disease, ethical study design, and compliant study conduct in accordance with recognized regulatory standards. Long-term planning and methodical approaches in the design of studies of early application of medical devices can mitigate conflicts of interest or improper research oversight that could result in harm or injury to study subjects.