Investigator Initiated Trials (IITs) can be a valuable part of a pharmaceutical or medical device manufacturer’s marketing claims arsenal. IITs are relatively low cost, because much of the upfront work is performed by the investigator, and the investigator normally “donates” facilities and staff to the conduct of the trial. In addition, ideas received from independent researchers can be a source of valuable new claims concepts, and the perception of the independence of the research is stronger than it is for company directed trials. They have the added benefit of cementing relationships with investigators with clinical and research expertise, valuable insights into unmet patient and physician needs, and the potential to contribute to the future success of the organization. On the other hand, companies that support IITs face a number of potentially serious risks — legal, ethical, and financial — that need to be managed up-front.

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