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Pharmaceutical Processing World

Electronic Data Capture: Changing the Landscape of Clinical Data

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Clinovo introduces another way to capture and manage data during clinical trials.

Clinical trials, a necessary but often elongated process in the creation/approval of a drug, can take years—sometimes over a decade. During this time, countless information is recorded about the patients, the drug, and the interaction of the two. This information is critical not simply for pharmacologists conducting trials, but for manufacturers as they use that clinical data to establish the right manufacturing processes.

In the past, paper-based systems have been utilized to record this essential information. Today, electronic data capture (EDC) systems have emerged and can be used to capture and manage data during clinical trials—after which point it can then be presented to the FDA for approval. EDCs collect clinical trial data electronically, which is one potential solution for streamlining data processing.

According to research cited by Clinovo, approximately 20% of clinical trials are using EDCs worldwide, while the other 80% of clinical trials capture data on paper or in Excel spreadsheets.

But EDCs are not new to the industry.

“EDC systems have been around for a couple of decades,” said Glenn Keet, CEO of Clinovo. “To this day, you can still install some of the databases on your server. In recent years, however, there have been more cloud-based systems.”

In the past, someone had to make case report forms (on Microsoft Word or a similar program), print out the forms, make and distribute these booklets to sites, and then the data was hand-written onto the forms. Problems to this method of data entry could be something as minute as an inability to read someone’s handwriting, to recording the wrong date, to people who neglect to fill out every line—which can prove to be very large problems down the road. Then, once the data was collected, it had to be entered into a database and verified to ensure that there were no errors made during that process.

Today, however, data entry have transitioned to being inputted via the computer and other technologies.

“The idea of EDC is to restrict data entry: to be invalid (if possible), to avoid trivial data capture, to be readable (since it’s recorded on the computer), and to have more complex rules that allow you to compare data across case report forms,” said Keet. “EDC can warn the user in real-time if the data is outside the normal range and it minimizes (or eliminates) source data verification.”

In the U.S., approximately 50% of clinical trials are captured on paper and 50% on EDC. Worldwide, 30% of clinical trials utilized EDC and 70% use paper. This largely due to FDA requirements, as they require certain formats of data that is submitted.

“Cloud-based products are the next generation and are being accepted within the clinical trial industry,” said Keet. “Clinovo and some of our other competitors are trying to get more studies into EDC by virtue of having cloud-based systems and do-it-yourself tools. We think that will tilt the 50% rate in the U.S. of who is using EDC systems.”

This article can also be found in the November/December 2015 edition. 

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