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The electronic revolution in clinical trials is still a work in progress, but researchers say it's time to bring EDC to the preclinical world.
Electronic data capture (EDC) may well be the future of data collection in clinical research environments, but some software companies are taking the concept a step further. At least two companies are developing tools that would enable researchers to electronically gather data in preclinical studies.
EDC allows researchers to upload data directly from electronic measuring devices – scales, calipers, chip readers, etc. – onto a computer. The software then sorts the data and graphs them instantaneously to create an up-to-the-minute analysis of the experiment.
The two leaders in preclinical software development are New Jersey-based Innovative Programming Associates Inc., which makes a program called LABCAT, and San Francisco-based Studylog Systems Inc., which makes Study Director.
Professionals are split over whether these types of programs improve the quality and efficiency of research. The question at hand involves whether the current procedure for data collection – in most animal studies, that involves jotting down data in notebooks, then transferring them onto Word processors – adequately serves its purpose, or if using electronics would be more efficient.
Dr. Ingegerd Hellström, an affiliate professor of pathology at the University of Washington and former vice president of Bristol-Myers Squibb, said he believes the current methods of data collection are outdated.
“There are all kinds of possibility for error, and I think that this improved method can decrease investigator error,” Hellström said. “I think that is of great value, and so this in my mind is one of the great advantages of this approach.
“Of course, lots of good work has been done for a hundred years in animal experiments without this fancy software. One doesn’t necessarily need a computer for doing anything, but one is a fool if one doesn’t use the modern technology which is available.”
Since using EDC devices eliminates the need for handwriting data, it decreases the risk for clerical errors. Melinda Hollingshead, chief of the Developmental Therapeutics Lab at the National Cancer Institute (NCI), noted that the most common laboratory errors are clerical – in other words, dumb mistakes that could be avoided by using more sophisticated data gathering processes.
Hollingshead’s lab was the first to implement Study Director, in 2004. Hollingshead said she would recommend the software to anyone who conducts a large number of animal studies, especially if they involve collecting precise data.
Others, however, are slow to accept EDC software as inherently better than the status quo.
“In a generic sense, you have an opportunity to increase your efficiency and also improve the reliability of the data collected,” said Ken Boschert, associate director for the Division of Comparative Medicine at Washington University in St. Louis. “On one hand it does it, but on the other hand it also has the potential to introduce new variables that you didn’t previously consider.
“In my experience, new does not always mean improved.”
On that point, Hollingshead agreed, noting that her lab tried several home-built software programs that actually made the process of data gathering more complicated than taking notes by hand. She has encountered no such problems with Study Director, however.
Study Director is the brainchild of Eric Ibsen, a former cancer researcher who had worked on animal studies for 15 years. Frustrated with what he perceived as inefficiencies in animal research, he set out to design software that would be flexible enough to manage studies and give researchers the ability to change designs on the fly.
Studylog currently has nine customers, including the NCI and three of the 10 largest pharmaceutical companies in the country. The company is now working to create an online database that allows researchers to share their results with the scientific community.
“It’s the preservation of tribal knowledge,” Ibsen said. “It’s having that information at your fingertips where it can be used, and where it’s stored consistently.”
Eventually, Ibsen wants to expand his software to all phases of drug development, from toxicology studies to clinical tests, to create “the first fully integrated system from bench-top to bedside.”
“I want to make drug discovery as optimally efficient as possible,” Ibsen said.
The goal, if not the means, is something all researchers can agree on.