Task Force Calls for Joint EDC Standards

Biopharmaceutical and ehealth initiative standards must converge to help electronic health records (EHRs) become a regular source for clinical research, said a discussion paper from the eClinical Forum and PhRMA EDC/eSource Task Group.

The group, composed of health IT leaders from dozens of companies including Abbott, Covance, Eli Lilly, Phase Forward and Quintiles, wants to help convince ehealth initiative groups of the value in involving the biopharma industry in planning and architecting ehealth environments so that the clinical research requirements are included and EHR systems can be used to collect clinical research data.

Electronic data capture (EDC) systems capture and maintain data:

That are first recorded on paper and then entered into a sponsor's EDC tool; From a lab transmitted electronically to the sponsor; That are first captured via instrumentation; and That are entered by patients via ePRO/eDiary systems into personal devices or web-based systems.

While praising EDC, the task force admitted it was far from perfect. For starters, it acknowledged that the "transformation from paper to EDC has not been smooth." Transcription from paper or electronic charts to EDC results in "extensive duplication of data entry and lack of clarity on what is the original source," the discussion paper said. Another challenge: The typical investigative site has three different EDC systems.

Among other fixes, the task force called for:

Joint data standards for EDC, interpretation and exchange; A system compliant with regulatory and clinical research requirements for system validation and data reliability; and Controlled, secure and regulatory-compliant processes for releasing and transferring data between healthcare and research systems.

The task force called for biopharmaceutical and ehealth initiative standards to converge "such that common data exchange standards allow for flexible data interchange and interpretation between EHR and clinical research systems." It also called for common data standards to be adopted "extensively" across clinical research sponsors, and the adoption of a digital identity standard.

Regulators must also accept data sourced from accredited EHR systems for research purposes, the task force said.

It also called for regulatory guidance for eSource. eSource through the use of EHR must be part of a system with "appropriate validation and built-in security and audit features and under system life cycle control," the task force discussion paper said.

The task force called for several interim steps from industry and regulators to advance EDC. For starters, it urged both to support joint standards including the Clinical Data Interchange Standards Consortium, HL7 and SAFE.

The task force also called on the biopharmaceutical industry to audit investigator EHR systems, urge investigators to purchase only EHR systems compatible with clinical research and continue its involvement in eSource pilots.

The task force called on government agencies to modify privacy regulations to accommodate clinical research needs, as well as private citizens, and develop an EHR certification process.

Failing to advance EDC will harm the entire industry, the white paper suggested. "Reduced efficiencies could lead to a decrease in introduction of new therapies while increasing their costs," it said. Failing to advance the technology could also mean that the research community would not be able to "quickly react to emergent healthcare" crises.

More information on the task force is at www.eclinicalforum.com (http://www.eclinicalforum.com). Comments on its proposals should be sent to info@eclinicalforum.com (mailto:info@eclinicalforum.com).