FDA working with CDISC to develop standards for electronic data exchange: woodcock.

PHILADELPHLA--FDA is working to increase its involvement in standards development in its "Critical Path" initiative by "partnering with a number of organizations in an open, transparent way to develop terminology and interoperability standards for use in animal and human studies," including the Clinical Data Interchange Standards Consortium (CDISC), noted Janet Woodcock, M.D., Acting Deputy Commissioner for Operations.

With such standards, she noted at the DIA annual meeting, researchers in clinical trials could utilize any type of computer system, provided that the terminology is stable and standard.

CDISC is an open, multidisciplinary, non-profit organization that has established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. Woodcock said the group is working on terminology and interoperability standards, and HL7 [Health Level Seven] also has accredited some standards.

Health Level Seven is one of several American National Standards Institute (ANSI)-accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. HL7 develops specifications, the most widely used being a messaging standard that enables disparate healthcare applications to exchange keys sets of clinical and administrative data.

"However," she said, "a national health architecture has not yet been established, and that is where most of the clinical data is." So at this point, we do not know how clinical trial systems would work with electronic health records.

Speaking in more detail about the agency's "Critical Path" initiative, Woodcock provided more information about the opportunities list it published in March, "which brings some concreteness to what needs to be done," she said. Some of the topics include:

* To develop better evaluation tools and to better evaluate the effectiveness of medical devices and drugs;

* To streamline clinical trials through automation and standardization; and

* To use bioinformatics to glean more information from clinical trials.

Woodcock also stressed the need to modernize FDA's regulatory program to fit today's realities, of which Critical Path is a key part.

"Critical Path" is the agency's effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product or medical device is transformed from a discovery into a medical product.

"There are many more studies today that involve children. We want to encourage studies with children. Our ideas about vulnerable populations have changed; we no longer think we should not study them. We just have to make sure we do so carefully," said Woodcock.

"Some of the other things we need to work on are to facilitate more effective IRB oversight, and to assure that public that IRBs are operating effectively." It is important to assure that IRBs have the public's best interests at heart and are not overwhelmed by IRB reports.

The agency also needs to provide regulatory guidance that encompasses all modern trial arrangements. The publishing of final guidance on how to operate centralized IRBs should aid in this, she said.

Woodcock added that soon there will be a requirement for the registration of IRBs, which will feature a central database of existing IRBs. "We are reviewing comments on this and want to finalize it soon," she said. Woodcock offered no specific date.

Next, she stated that the agency is in the process of finalizing a under an IND. Also, a rule is coming on how firms should report information where they have uncovered data falsification. "I think it is in our best interest to find out where people have crossed the ethical line." she noted.

Currently, some companies are afraid to report on data falsification because it could put the clinical trial in jeopardy. Woodcock said: "We need to make tit clear that we don't think companies are trying to get criminals to conduct trials. We want you to monitor your trials, but we are not going to penalize you if you report data falsification to us."

By Joseph Pickett, Managing Editor