FDA expands search capabilities

U.S. Food and Drug Administration

Officials from the Food and Drug Administration's Center for Drug Evaluation and Research (CDER) recently expanded their use of search technology that helps scientific reviewers who approve new drugs.

CDER is the division within the FDA that ensures the safety of new drugs, including marketed prescription and over-the-counter drugs. Agency officials have been using Convera Corp.'s RetrievalWare for a decade or more. Recently, they introduced a Web-based version and expanded the searchable data sources for the agency's 2,500 scientific employees.

Now reviewers can search as many as 200 file types and formats — Microsoft Corp. Word, image, PDF, HTML, Extensible Markup Language and others — that are stored in relational databases, document management systems and repositories. The Convera technology also can be used to search video and audio files and documents in a variety of foreign languages, although those particular features are not ones that CDER uses.

Reviewers assess the safety and efficacy of thousands of new drugs before approving them for sale. They also monitor drugs through the center's adverse event-reporting system, which tracks serious drug reactions that can result in hospitalizations or deaths. Higher quality searches help reviewers from various disciplines — chemists, microbiologists and medical officers — find information they need in a limited time.

Using the expanded search capability, reviewers are obtaining better information, said Helen Mitchell, CDER's enterprise search product manager. The biggest benefits have been the quality and timeliness of the reviews, she said. Reviewers can now locate documents "they previously couldn't find that easily."

Initially, reviewers began using the RetrievalWare technology to search for trade-secret information, such as documents that list the composition of capsules and how they might react when drug products are introduced. Instead of waiting several weeks for a physical file, reviewers found they could locate previous reviews online within minutes, Mitchell said.

Reviewers then expanded their search capabilities to encompass millions of adverse-event reports. Those reports were originally stored on microfiche but later digitally scanned. Now reviewers can conduct specific and wide-ranging searches on the reports, Mitchell said.

Convera's RetrievalWare is used in civilian agencies such as the State Department and the Social Security Administration, but mostly in Defense and intelligence agencies, said David Connor, vice president of federal sales. About 70 percent of Convera's business is with the federal government.

In the future, FDA officials might want to use the search technology's language capabilities to search for drug reviews from foreign countries, said Jack Warden, Convera's director of federal channel sales. "A lot of countries will approve drugs long before we do," he said. "In that case, they may have feedback on testing or reactions to drugs. You may want to incorporate that data in the future."

Mitchell said future enhancements might include the foreign-language capabilities, concept searches for medical terms and searches for unstructured data such as e-mail messages.

Hadley Reynolds, vice president and research director for the Delphi Group, said Convera has spent a great deal of time over the past two years on classification and taxonomy to improve the accuracy of text analytics and search results. Business users want to work with both structured data and text, and the new capabilities of search products are making it much easier for them to be successful finding the answers they need to work with, he said. But, while much of the information used in business focuses on transactional data, the enterprise applications that house that data do not deal well with text-based information, he added.

"At some point, there has to be a bunch of information of more anecdotal character that somebody types in," Reynolds said. "The difficulty that everyone finds is how to make anecdotal information or text-based information as accessible as structured information."



Officials at the Food and Drug Administration's Center for Drug Evaluation and Research are using Convera Corp.'s search engine technology to conduct specific and wide-ranging searches.

Using RetrievalWare, FDA scientists search through:

3 million adverse-event reports.

75,000 biopharmaceutical reports.

75,000 drug master files.

15,000 division files, which are growing exponentially, according to FDA officials.

Source: Food and Drug Administration


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