Several recent analyses have called attention to the increased scientific and operational complexity of today’s clinical trials. These studies have revealed that:
- During the 10 year period ending in 2010, the average number of endpoints per clinical trial protocol has more than doubled, and the median number of unique procedures and the procedures performed per protocol have increased by 48 percent and 57 percent, respectively.
- The incidence of non-core procedures* almost doubled from 2009 to 2012. A variety of factors explain the inclusion of non-core procedures in clinical trial protocols.
- Each year biopharmaceutical companies spend an estimated $5 billion in direct costs to pay for non-core procedures. In addition to consuming about 20 percent of the trial budget, these nonessential procedures can impose an unnecessary burden on patients and clinical site personnel.
- A typical clinical trial in 2012 generated about 1 million clinical data points, almost double the amount of data that was collected in 2002. However, biopharmaceutical companies do not include 15 to 30 percent of the clinical trial data in their NDAs.