FDAnews
www.fdanews.com/articles/84698-firms-enhance-trial-efficiencies-through-electronic-case-reporting

FIRMS ENHANCE TRIAL EFFICIENCIES THROUGH ELECTRONIC CASE REPORTING

February 20, 2006

The use of voluntary electronic case reporting to the FDA frees up resources that lets drugmakers focus on interpreting clinical trial data rather than handling the data, according to pharmaceutical industry officials.

The benefits of electronic case reporting only begin at the clinical trial level, said William Gregory, director of Worldwide Harmonization at Pfizer. Leveraging E2B as the standard of electronic exchange of individual case safety reports (ICSR) provides a valuable "continuum" that allows firms to achieve business efficiencies from clinical trials through product roll-out and beyond, he said at a recent Drug Industry Association (DIA) event.

E2B is one of several electronic standards for electronic data transfer -- others include the electronic common technical document (eCTD) and structured product labeling (SPL). Health Level Seven (HL7) is one of several American National Standards Institute (ANSI)-accredited standards developing organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. HL7 is working to expand the use of E2B across the entire healthcare sector to speed the exchange of important safety information. The introduction of standards is widely viewed as a tool to drive down the cost of technology by creating a competitive marketplace for vendors.

E2B has become the standard for the electronic exchange of ICSRs, said Kostas Kidos, senior director of clinical and regulatory information services at Merck. E2B is already widely used by regulators and industry and is likely to be adopted by the extended healthcare sector, Kidos added.

E2B also can be beneficial for a company considering a clinical trial for a new indication for an approved drug, Kidos said. Using E2B the first time around makes it much easier, more efficient and faster to communicate subsequent results with the FDA, he said. It creates information collection mechanisms that make it far easier for FDA investigators to access and interpret any new data.