It’s no secret that the cost of healthcare has skyrocketed. A primary reason is the expense of taking a drug or device through a lengthy clinical development process, which can last 8 to 10 years and cost upwards of $1 billion. And only a small percentage of these products ever recoup the huge investment.
Electronic data capture (EDC) software has proven effective in reducing the cost of clinical trials. Lower clinical trial costs lead to lower costs in diagnosing and treating disease, which can ease the economic impact of healthcare on society. In the past, EDC software has been very expensive and complex to implement – used primarily by Big Pharma to conduct large-scale clinical trials. But the rapid advance of development tools for Web-based software, along with increased competition among EDC vendors has dramatically lowered the cost of EDC. Improved usability and a reduced need for customization also mean faster, less expensive study deployment. As a result, thousands of smaller biotech companies and medical device manufacturers can now afford EDC software. Just as importantly, it can now be used by large pharma in thousands of early phase trials that previously were too small to warrant the expense of EDC.
Consider a medium-size biotechnology company conducting a clinical trial enrolling 70 subjects over 9 months. Traditionally, the smaller scope of this study meant a paper trial, requiring the faxing of thousands of pages back and forth between coordinators and monitors. With no way of checking values at the point of entry, monitors would spend hours generating queries due to typos or out-of-range values. Additionally, the data needed to be entered a second time electronically into a data management system. This cumbersome process added an extra 1-2 months (or more) before the clinical trial database could be locked. As a result of this extra time, millions of dollars were added to the cost of conducting the trial.
Compared to paper trials, EDC enables every data value typed into an electronic form to be immediately checked for problems. By minimizing data entry mistakes, the process is vastly simplified. Accordingly, that medium-sized biotech can now lock its trial database much earlier than it could using paper.
Lower EDC software costs have dramatically increased EDC adoption. In 2000, fewer than 10% of all clinical trials used EDC because of the expense. Today, more than half of all trials are conducted using EDC, helping contain the cost of bringing new products to market. Within 5 years, it is estimated that 80-90% of all trials will use EDC.1 That’s good news for healthcare, and good news for patients.
1. Drug Information Association’s (DIA) 3rd Annual Clinical Forum survey, “Investigational Site Perspectives on Clinical Trial Information Systems,” update to 2001 survey published on the topic.