Trends Bode Well for Increased EDC, Experts Say

Electronic data capture (EDC) in clinical trials and in other day-to-day operations is on the rise and likely to keep climbing, experts tell PIR.

“Many companies are going in that direction,” said Melanie Bruno, vice president of regulatory affairs and quality at Kendle. While larger drug and device companies are moving toward EDC faster, she predicted: “Ultimately, all will” because it is so much faster and potentially more accurate.

Contract research organization (CRO) PRA International is bullish on EDC. Later in the first quarter of 2006 it plans to launch an enhanced EDC platform it says will enable it to provide EDC for all studies globally. Its EDC platform will also offer a hybrid EDC/paper solution. The CRO has already completed 49 EDC studies involving nearly 21,000 patients through a variety of technology platforms, Bruno said.

Smaller Companies Go Slower

Many smaller firms involved in relatively less-involved clinical trials tell PIR they haven’t yet felt the need to harness EDC, but that could change. “Those smaller companies may decide to outsource data collection in trials to firms that specialize in EDC,” Bruno said.

PRA said it processed 401 total projects in 2005, involving about 103,000 patients and 1.5 million pages of data. That work resulted in 76 databases being locked, the majority for integration in upcoming regulatory submissions, PRA said Feb. 1.

Additionally, using Clinical Data Interchange Standards Consortium (CDSIC) methodology, another 77 database freezes were realized, many for ongoing data review by data safety committees (DSC), the company said. PRA has global data centers in Kansas, British Columbia and Wales.

In one DSC program, PRA’s global data centers and clinical operations staff worked to resolve more than 30,000 queries in a six-week period across 23 countries.

PRA also has plans to introduce an integrated web portal later in 2006, the company said.