New and improved data collection methods

General research could benefit, as well

Clinical research sites involved in the Rare Diseases Clinical Research Network (RDCRN) have numerous advantages from the collaborative work, including the ability to access a data and technology coordinating center (DTCC).

The network, created through National Institutes of Health (NIH) funding, has a DTCC charged with developing a scalable information systems approach to collecting data from many different types of disorders in research settings, says Jeff Krischer, PhD, head of the DTCC at the University of South Florida in Tampa, FL.

The goal is to incorporate into the system data standards across studies, diseases, and sites, Krischer says.

CR sites collect data from their natural history studies and treatment trials and send these to the DTCC.

"We all use the same format and form and went through numerous meetings and phone calls to come to a consensus of what data was important, how to score it, and how to conduct interviews and exams," says Steve Skinner, MD, a senior clinical geneticist and associate director and director of clinical services at the Greenwood Genetic Center in Greenwood, SC.

The DTCC has helped sites navigate the web site and use the database and tools, says Susan Minnix, RN, BSN, research nurse coordinator at the University of North Carolina at Chapel Hill.

"They can post same-time meetings and have your screen come up with whomever is presenting them," Minnix says. "So they educated us about what those tools are."

The key is for the DTCC to be consistent with the NIH roadmap, which includes making data available to the larger research community, Krischer says.

"The larger research community could benefit from the studies we have underway as well," Krischer says. "In the application of data standards, we not only review in terms of applicability to the disease settings we have, but participate in future refinement to make sure they are robust enough to address other clinical research issues."

The DTCC developed the approach with the consideration that the center is supporting 10 research consortia, which represent more than 55 medical institutions in eight countries, he says.

"So the data technology and capture systems have to be robust enough to support studies being done in such diverse settings," he says.

Some of the ways the DTCC has captured data is through interactive voice response systems to collect patient reported outcomes, and information is captured on-line from various types of imaging data, such as MRIs, etc., Krischer says.

Another innovative approach is the patient contact registry, in which individuals who are interested in participating in clinical research can register and be contacted when new trials are open, Krischer explains.

"That's a very valuable resource that we hope will stimulate more rapid accrual to studies," he says. "More than 3,000 individuals are enrolled in that registry, representing a valuable resource for researchers to draw upon."

Most of the DTCC systems are built around Web-based data capture and management, Krischer says.

"We can also receive data from paper forms that are scanned and computer read," he explains. "We use those in special settings where it is more appropriate than data entry on a computer."

At the RDCRN site at the University of Alabama, Birmingham, research information was collected on a regular form and faxed to the DTCC, rather than hand-entered, says Jane Lane, RN, BSN, a research nurse manager at the Civitan International Research Center, at the University of Alabama, Birmingham.

"We wanted to get information entered in a timely fashion, and we were backlogged because we'd collected so much data before the data center was ready to accept it," Lane recalls.

"This process greatly streamlined things for us, so that we could come back from the clinic and fax data there," Lane adds.

Doing it this way did make things more stressful for the DTCC staff, she notes.

"If we didn't write correctly, they might have to hand-check it," Lane adds.

The DTCC has automated systems for data quality control and monitoring, including adverse event monitoring in all studies, Krischer says.

"It can be distributed to the appropriate medical review officers for review electronically," Krischer says.

"We have a system in which we can monitor them in terms of our review and analysis, as it pertains to the safety of the ongoing study," he says.

"It's a continuing process," Krischer adds. "As we open new studies, there are new study requirements."

For example, the DTCC added a system by which we can track distribution of investigational agents, links to research pharmacies at participating sites, manage distribution of study drugs, and replenish it so dispensing of study drug can occur, Krischer describes.

"We make sure there are adequate supplies, and we make sure we can do the statistical component and that the study operating characteristics are maintained throughout," he says. "We have the ability to track biological samples collected by studies, whether they are going to repositories or tissue banks, and we can link samples and data generated as well."