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By Brian Reid

September 9, 2002 | WASHINGTON -- Electronic submission of investigational new drug applications with the FDA should help speed the agency’s earliest review of new-drug data, according to Shannon Williams, the manager of PRA International’s electronic submissions group and a former FDA reviewer.

“If you can shave off time, it’s all the better for your company,” Williams said. “The bottom line for doing this is to facilitate the review process.”

Williams laid out the process – and the advantage of the system he said would prove quicker and easier to use than the enormous paper files that now predominate – as part of a workshop on hot topics in clinical trials held by the Regulatory Affairs Professional Society (RAPS) in Washington, D.C., early last month (Over the life of a trial, the paper trail can run from 50,000 to 250,000 pages, Williams said.)

The FDA expanded its electronic submission program earlier this year and formulated the requirements by which companies could use paperless filing to request clearance of so-called investigational new drug applications for biologics. Investigational new drug applications, known as INDs, are requests for permission to test a new drug on humans.

Typically, INDs are rambling documents, with many updates filed at different times as new information about pre-clinical research and clinical results become available. Companies testing a drug must file regular reports with the agency, making electronic filing attractive.

“They’re going to have a greater impact on the process” than other types of electronic submissions introduced at the FDA, says Bernadette Billet of Liquent Inc., a company that has helped biotech companies from Chiron to Biogen prepare electronic submissions. Billet oversees Liquent’s CoreDossier program, designed as an outsourcing solution for companies seeking to file electronic submissions.

The e-submission, in PDF form, should be bookmarked and hyperlinked, Williams said, allowing agency reviewers to easily navigate enormous files. FDA protocol requires that the documents be electronically searchable, freeing reviewers from pawing through old documents. Williams presented the process for creating the file, from the roadmap and table-of-content documents that the agency requires to the specific file names suggested by the FDA.

The agency has been moving toward paperless submissions since 1997. It has outlined in detail the process by which applications for approval for new drugs and biologics can be filed electronically in PDF. Though that avenue has been increasingly popular with drugmakers, the agency hadn’t offered guidance on how that philosophy extended to INDs until March.

There are signs that the FDA may be moving toward a framework in which all documents are filed electronically. The agency in May proposed a rule that would require certain drug and biological labeling in new drug and biological applications to be filed electronically, the first time the agency has proposed requiring a paperless approach.

The FDA’s rationale? “Accuracy and speed on the part of the reviewer,” according to Lester Crawford, the agency’s deputy commissioner.

Billet agrees. “They both have access to information at their fingertips,” she says, and that eliminates what she calls a “volleyball match” in which reviewers and companies are forced to trade phone calls because each side can’t find the same document.

The two-day RAPS meeting, which focused on a range of clinical trial issues, also underscored the importance of information technology in managing trials that are becoming increasingly complex, both in their administration and in their statistical rigor.

In the program’s closing plenary, Nancy Stark, the president of Clinical Device Group Inc., said the landscape for clinical trials would shift in the coming years as the importance of protecting research subjects becomes paramount. For companies sponsoring the research, she said, a key to that effort will be “timely, ongoing communications of relevant information to the organization” and researchers conducting the trial.

And companies are already looking to capitalize on that need for better information. Kendle International Inc., a contract research organization, announced last month that it had released a new version of its TrialWeb service. The Web-based system is designed to provide a central clearinghouse for information about a company’s drug trials. It uses a password-protected site to give those running the trials access to project reports and discussion forums, all in a format that can be searched.

“Technology continues to play an important role in compressing clinical development timelines,” says Chris Bergen, Kendle’s president. The TrialWeb would be “critical to our customers’ ability to bring life-changing drugs to market more quickly and efficiently,” Bergen said.

 





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