Case Report Forms: Why paper is so patient

29.07.2010 13:05

High investments, time disadvantages: What hurdles electronic CRFs still have to overcome

It has been predicted for many years that paper documentation forms in clinical trials will soon become a thing of the past. In fact, the research-based pharmaceutical industry's interest in data collection using electronic Case Report Forms (eCRF) is increasing noticeably. In contrast to the handwritten paper version, direct electronic data capture (EDC) enables immediate availability, the data is immediately accessible on the web, and workload and thick stacks of files are reduced. However, some pharmaceutical companies and investigators do not yet standardize on electronic data capture systems, the modern way of documenting clinical reports. The paper form has not yet been replaced. Because practice shows that paper has advantages that many users do not want to do without. No technical hurdles or software installations as well as a comparatively short time required to start the study are the top priority.

“Especially in studies with a few patients or those that last a long period of time, setting up an EDC system is often not worthwhile,” explains Dr. Michael Sigmund, who has been working in clinical research for more than 20 years. The employees of his company, SSS International Clinical Research GmbH, supervise projects in clinical test centers. Sigmund estimates that around a quarter of projects are still documented on paper instead of typing the data directly into the computer. There are many reasons for this: “An EDC system is always a major investment that requires time, money and patience.” A corresponding program only makes sense if it is easy to use and easy to understand and thus provides a real benefit for everyone involved offers advantage.

“Incorrect or poorly programmed electronic data collection forms not only annoy my employees, but also the investigators. This can even lead to those involved becoming demotivated,” Sigmund points out. “Any resulting delays in patient recruitment would be an expensive worst-case scenario for the sponsors.” Problems also arise if, for example, the internet connection is poor or the devices first have to be delivered to the test centers, which are often located around the world.

05.07.2010