EDC Adoption Brings Many Benefits for Sponsors

Electronic data capture (EDC) in clinical trials offers a host of benefits for sponsors if done properly, an expert said at a recent FDAnews audioconference.

When adopting EDC, companies should look for solutions that are easy to use and are based on validated and proven technology, with scalable architecture and an "eClinical vision," meaning "the ability to integrate with and share data with solutions for other enterprise issues," said Paul Bleicher, chairman of Phase Forward, Waltham, Mass.

Look for an EDC vendor with global presence, clinical knowledge and expertise, an experienced service staff, 24/7 support, comprehensive customer experience and references and financial stability, he advised.

On a technical level, Bleicher said, it is important when adopting EDC to "embrace standards natively," that is, from the start, including the use of XML (Extensible Markup Language, a next-generation internet programming language) and standards promoted by the Clinical Data Interchange Standards Consortium and HL7, an organization that is developing data standards for all healthcare operations.

To overcome institutional resistance, "you have to have champions at all levels of the organization," from management to hands-on users, Bleicher said. "Many companies are creating environments in which every trial is done with EDC, and you have to apply to a committee to do a trial without EDC."

Other organizational advice for EDC adoption Bleicher highlighted included:

Defining new processes and redefining old processes to make trial management most effective; Building an EDC team with enough resources and the right skills; Educating and retraining employees; Defining, measuring and evaluating effectiveness; and Understanding that measurable return on investment in EDC can sometimes be long-term.

EDC can be used to improve safety monitoring in clinical trials, which is a hot topic right now, Bleicher said. "There have been multiple waves of concern over safety, but this wave is more intense and more focused on developing solutions."

EDC systems provide databases that consolidate enrollment, case report form, safety and lab data for analysis, Bleicher said. EDC does this by providing data rapidly, offering clinical trials signal detection and "in stream" monitoring and management, which in turn leads to pharmacovigilance, one of today's clinical trial watchwords.

A sponsor using EDC can integrate clinical trial safety data into its postmarketing adverse events database, capture data for registries and use it to implement risk management action plans.

In this way, clinical trial data can be used to add insight when post-marketing safety problems arise, with pooled data from multiple clinical trials and post-marketing registries offering a more complete risk analysis. Clinical trial safety data can be analyzed within the context of post-marketing safety data for class effects or correlations between structurally similar compounds, Bleicher said.

EDC can also improve adaptive trials. With EDC, you can arrange for "just in time" clinical supplies that can save time and money. EDC also makes it easier to develop sample size modifications based on variance and end unsuccessful trials earlier.

By using EDC, adaptive trial sponsors can set up dynamic treatment arms and dosing groups, making it possible to get more accurate dosing evaluation and to combine Phase I and II and Phase II and III trials. EDC also helps with adaptive randomization and resource allocation based on risks and returns, Bleicher said. -- Martin Gidron (mailto:mgidron@fdanews.com)