TRAINING

By Ann Neuer

Nov. 24, 2008 | The Clinical Data Interchange Standards Consortium (CDISC) was recently chosen by the FDA to provide training to FDA reviewers on a whole host of CDISC topics. The training will take place over a two-year period and will be managed by a contract that CDISC won by competitive bid. The contract, valued at $230,000, calls for CDISC to develop content and teach the reviewers about CDISC standards so they will be better prepared to evaluate data that are transmitted to the agency using those standards.

According to George Rochester, lead mathematical statistician for the Drug Safety, Quantitative Safety and Pharmacoepidemiology Group within the Office of Biostatistics at the Center for Drug Evaluation and Research (CDER), “The training is meant to provide reviewers with the tools to communicate with sponsors as they move toward making data standards a part of development.” Rochester says that lack of training slows down the review process and without it, reviewers would be unprepared for the modern review process that is unfolding within CDER.

Frank Newby, CDISC’s chief operating officer, is gearing up for the training, which he says will differ from the usual training. “[It] will not be traditional CDISC training on how to create and set up data to be sent to FDA. Instead, it will focus on how reviewers will actually process the data from their desktops. We are putting the emphasis on how to use the datasets instead of how to build them,” he says.

The FDA reviewer training, slated to launch in early 2009, will have four topics: CDISC Basics; CDISC Study Data Tabulation Model (SDTM); CDISC Analysis Data Model (ADaM); and Advanced Topics on CDISC Standards. Each reviewer will not necessarily have to take all four courses, but according to Newby, it is expected that FDA will want all attendees to take the CDISC Basics module as well as the SDTM course. Reviewers will be evaluated upon completion of courses.

Training will be offered in three modes—live classroom, online internally at FDA through the videotaping of live classes, and through a structured virtual learning method in which a speaker presents scripted material with slides. The online version of videotaped classes will be indexed to allow the viewer to jump to various topics within each course. The virtual learning module is expected to be shorter in length than the other two choices and its content is still being hammered out.

The live classes will be given on a frequent basis over the two-year period, some 36 times across the four courses. The SDTM course, for example, will be offered 17 times. “We are trying to offer the courses in a just-in-time manner to reviewers when they are about to receive new drug applications,” Newby comments.

CDISC has several partners for the training project. Octagon Research Solutions will be working on content for the CDISC Basics module along with Frank Newby who will be the presenter. Octagon is also creating the SDTM module and will be its presenter. Destiny Corporation, a business and technology consulting firm, is on board to videotape the classroom courses and format them for online use within FDA.

Jack Shostak

The ADaM course, which deals with data analysis, will probably be of most benefit to statistical reviewers at FDA and is being developed by Jack Shostak, associate director of statistics at Duke Clinical Research Institute, along with the ADaM team. Shostak will be teaching this course, which will include content from version 2.1, the latest edition of the ADaM model slated for release in early 2009.

The training project was started by George Rochester’s group at CDER, but there is interest from other branches within FDA such as the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH) and the Center for Veterinary Medicine (CVM).

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