COSTS OF DEVELOPING A NEW DRUG. The costs of developing a new drug continue to increase at rates exceeding the general inflation rate. The Tufts Center for the Study of Drug Development now estimates that it costs $802 million to bring a new drug to market. In 1991 the cost was only $231 million. This cost includes preclinical and clinical research costs and includes the substantial costs of those compounds that fail at any point in the research and development pathway.
 

PHARMACEUTICAL INDUSTRY SPENDING ON CLINICAL INVESTIGATION. In 2001, pharmaceutical, biotechnology, and medical device companies spent approximately $3.8 billion on clinical research, a 16% increase over 2000 levels.
 

CLINICAL TRIAL COSTS. DataEdge reports that the cost per research subject of performing a clinical trial has increased from $4,500 in 1990 to $7,200 in 2001. At the same time the number of procedures and tests per protocol is increasing at an annual rate of 8%.
 

GAO REPORT ON CONFLICTS OF INTEREST IN BIOMEDICAL RESEARCH AT UNIVERSITIES. The General Accounting Office reviewed five universities that are top recipients of NIH funds for policies and procedures regarding financial conflicts of interest. The GAO found that there was insufficient informing of IRBs about conflicts of interest, even when other university entities (administrators or conflict of interest committees) had handled a potential conflict matter. Not surprisingly, university records regarding financial interests were often not well organized. The GAO also criticized the government for not providing adequate guidelines to universities regarding institutional financial conflicts of interest. The complete report is available at http://www.gao.gov/new.items/d0289.pdf.