Edata Trial Works to Get Part 11 Compliance

Researchers at Siemens Medical Solutions (SMS) and the Technical University of Munich (TUM) unveiled last week a method of electronically transferring clinical data gathered at the source (or point of care) for use in clinical trials — but the method is not yet compliant with 21 CFR Part 11.

“We think it meets the spirit of the regulation,” Siemens General Manager of Clinical Trials Business Hugh Donovan told PIR Sept. 22. Siemens is working through the Clinical Data Interchange Standards Consortium (CDISC) in discussions with the FDA to secure Part 11 compliance, he said.

While he declined to predict the outcome of those discussions, Donovan noted that Part 11 was “not designed with source records in mind.” Donovan believes the FDA will have to address that issue in a new regulation at some point.

At its core, a trial using the new SMS/TUM method attempts to address the capture of clinical trial data, which has been labor-intensive and error-prone, requiring data to be transcribed into a paper case report form (CRF) or, more recently, entered manually into internet-based data capture systems.

SMS/TUM’s solution offers a scalable, automatic direct transfer of data between electronic medical records (EMRs) and electronic data capture (EDC) systems, overcoming interoperability challenges associated with systems that operate on different technical standards and work within distinct business environments, Donovan said.

Trial Shows Benefits of New Solution

One trial was an open-label, prospective, multi-user clinical trial, with stratification into two groups and a total of 90 subjects. It was designed to evaluate response rates to pre-operative chemotherapy in locally advanced breast cancer patients, stratified by HER2 status. Preliminary results for that trial found that 53 percent of eCRF data fields were filled in automatically, meaning they required only a single entry — as opposed to a source entry that must be re-entered again to transform it into an EMR. That figure was actually slightly higher than Donovan’s team expected, he said.

Under the SMS/TUM system, eCRFs are completed in less than a day, compared with the nearly five weeks required with paper CRFs, Donovan said.

Data entry time was reduced by 27 percent, he added. “I think it will get better as users become more familiar with it,” he said. Lab data was transferred every 24 hours, and data entry was performed during the actual patient visit.

The solution, which enables immediate data transfer, is being tested in a pilot study that was initiated in June 2006. Preliminary results of this pilot were released Sept. 19 at ExL Pharma’s 2nd Annual Merging Electronic Health Record & Electronic Data Capture conference in Washington, D.C., and during an eClinical Forum presentation in Paris on Sept. 20. Donovan said reception at the D.C. event was especially encouraging because those in attendance were committed to advancing EDC capabilities.

“EDC [alone] is not the final thing,” he said. “It’s a good step.”

The pilot implementation was designed to create an automatic EDC platform for two studies focusing on women’s health. One of the trials is evaluating the effectiveness of various types of chemotherapy on women with breast cancer. The second trial will evaluate the diagnostic value of the use of motion correction algorithms on magnetic resonance imaging, and is slated to begin next month.

Connecting Systems, Reducing Workload

The solution’s goal is to connect disparate systems using Siemens OPENLink and Soarian Portal so clinicians and research staff can automatically view, retrieve and disseminate clean data, while reducing the workload of manually collecting and entering trial data, Siemens said in a release.

The solution is designed to be flexible and compatible with any EMR product and EDC system, such as InferMed’s MACRO technology, which is used in this pilot, Siemens said.

The Soarian Portal provides web-based access to patient information through a secure, personalized portal. Single sign-on capability enables the integration of multiple applications and content to meet varying clinical workflow needs. Siemens OPENLink is an interface engine that supports the integration of web-based standards, and health system and research standards such as XML, HL7, SSL, X12, DICOM and CDISC. — Michael Causey