The negotiation and development of a clinical trial agreement.

A carefully negotiated clinical trial agreement will protect a biotechnology and medical device company in critical areas, including the management and control of data and confidential information, defining publication rights and the ownership of intellectual property. Properly constructed, the agreement can increase a company's value. This article will review the major provisions of a standard industry sponsored clinical trial agreement; the principle areas where there is likely to be differing views that need to be reconciled and interrelated ethical concerns. A form of clinical trial agreement designed for a single site therapeutic trial in the United States follows the article.