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.