Bill Gluck, Ph.D.
VP, DATATRAK’s Clinical and Consulting Services

In the 1980s and 1990s, one way to streamline the drug development process was to focus on data collection and processing. Technology was introduced into the data capture process in the late 1980s as remote data entry. The use of remote data entry was enhanced through the use of the internet, and data collection techniques soon evolved into electronic data capture as we know it today.
Given advances in technology and improvements in EDC applications the pharmaceutical, biotechnology, and medical device industries have not embraced EDC as the standard method of collecting clinical data. The debate continues about which is better – paper or EDC.
The use of paper is perhaps the easiest concept for most industry professionals to grasp. We have all been exposed to paper forms throughout our lives so the ‘technology’ surrounding a paper-based data collection application is second nature. In contrast, an EDC application is computer-based and, while the number of individuals who are not computer literate is decreasing, over time exposure to technology in general increases. Additionally, training materials have evolved and are leveraging technology.
Perhaps the most obvious difference between the use of paper and EDC to collect clinical data is the use of paper itself. There are printing and shipping costs when using a paper-based application (printing costs can run as high as $100 per casebook – for example a study with 500 patients at $100 per casebook would cost an estimated $50,000 before considering the cost of staff to prepare the books for distribution and shipping) that are not present when using an EDC application. In theory, there is no lag in the time from completion of a form in an EDC application to data being available for review as opposed to the completion of a paper case book form that then needs to be shipped to a data management center for processing before the data are ready for review – in the best scenario this could take several days. Additionally before the data review can be initiated in the paper-base application data must be double-data entered into the clinical data management (double data entry costs can be as high as $3 per page so a 100 page casebook that is completed can cost as much as $300/per casebook and for a 500 patient study cost $300,000) whereas entry in an EDC application occurs at the site.
The process to review and ‘clean’ data using a paper-based application takes time and is done away from the clinical site and records. Data for an EDC application are entered at the clinical site and the majority of edit checks is automatic and visible at the time of entry and therefore is resolved immediately which results in ‘cleaner’ data being entered and saved in the database. The number of queries are reduced in an EDC application between 65-90% when compared to the queries issued using a paper-based application. Perhaps the greatest advantage for an EDC application in contrast to a paper-based application is the availability of data, clean data, to make decisions regarding the progress of a clinical study. Additionally, safety data are more readily available, therefore the safety of patients and determination of safety trends can be defined earlier in the drug development process. Both factors are important in making informed decisions as to whether or not a drug development program will continue. Being able to make the determination earlier in the drug development process to discontinue a drug permits the pharmaceutical, biotechnology, and device industry to focus on the development of the best drug, biologic, or device candidates that will most benefit patients.

Reference: Paper vs. Web: A Tale of Three Trials, Mitchel, J.T., You, J., Lau, A., Kim, Y.J., Applied Clinical Trials: Internet Insight Section pages 1 & 2, August 2001