Clinical Studies and the Price of Information

Abstract

With the performance of clinical studies, pharmaceutical sponsors purchase data on the open market. The price of an individual study is usually known. Whether the price represents a good value, however, often is not. Moreover, whether two trials of different drugs have similar values is also frequently uncertain. The purpose of the current work was to ask and to devise a means of answering these questions. The multiple regression technique was applied to a sample of 56 clinical trials. Although therapeutic class and study location significantly influenced trial costs, the most important factor was the amount, but not the kind, of data collected. The number of case report forms alone accounted for approximately 65% of the variability in the price of clinical trials. Using the model, individual trials could be compared for value and the price range of new trials predicted.