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This article was originally published in The Gray Sheet

Executive Summary

DEVICE CLINICAL STUDY DESIGN TO BE DISCUSSED AT FDA/INDUSTRY/PHYSICIAN SYMPOSIUM tentatively scheduled for September. With the input of industry and medical professional representatives, FDA is aiming to define criteria for the design and execution of clinical trials of medical devices. The conference is expected to consist of a general discussion of principles that should guide the design and execution of studies and break-out sessions to discuss how the principles can be applied to various medical specialties. Arranging the symposium is the largest-scale step undertaken by the agency to involve the medical device industry in the formulation of upgraded clinical data requirements for device approval. FDA Commissioner David Kessler discussed agency plans to hold industry workshops on guidance development in a letter to Rep. John Dingell (D-Mich.) in August ("The Gray Sheet" Sept. 14, p. 5). In October, the agency co-sponsored its first workshop with the National Institutes of Health and industry representatives, at which clinical guidelines for ophthalmic devices were discussed ("The Gray Sheet" Oct. 19, p. 16). That workshop, which was limited to one medical specialty, will serve as a prototype for the larger symposium. Alan Andersen, acting director of the device center's office of device evaluation, discussed the agency's plans for clinical study standards at a Feb. 11 dental products advisory panel meeting in Bethesda, Maryland. "What we are suggesting is that, for the future," the approach should be "for industry, the agency, and the medical profession to make the investment right up front to talk about the proper way to design the studies" and "collect the data." ODE staffers plan to make similar presentations at other panel meetings during the year. Andersen said that the agency will bring up concerns about issues such as use of inappropriate clinical endpoints, inadequate study design, and inadequate sponsor control of clinical investigators at the symposium. Andersen stated that "with some frequency, we found that when device manufacturers approach looking at a particular device, they neglect to really focus in on just what endpoint they are trying to have for the product." Andersen added: "Rather than a focused endpoint, what we see quite often is endpoint shopping," in which manufacturers conduct studies, collect data, and then "see if there is a legitimate claim" the firm "can gin up." Instead, FDA wants "manufacturers to come in and work with FDA at the stage in which a study is being contemplated so that we can focus on what the right endpoint is," Andersen said. The agency also will be expecting manufacturers to "ensure that the data that is going to be collected will be adequate to demonstrate that" the endpoint agreed to by FDA and the manufacturer "is either met or not met." Andersen reiterated a concern expressed at the August meeting about the "overuse in the device industry of historical controls." Andersen also faulted clinical investigators for failing to adhere to study protocols defined by manufacturers. "We have seen serious problems crop up in being able to analyze data when in fact [investigators] go off and put their own little wrinkles on the protocol without telling anybody," Andersen noted. Andersen emphasized that new clinical trial standards would not be applied to device studies already under way. "If somebody has undertaken a study that began a year ago and it is going to reach fruition in a year and a half, it is not fair to change signals midstream, and we are going to have to find ways of accommodating studies" that are ongoing, Andersen said. The agency expects one product of the symposium to be an informal document outlining general principles for conducting clinical studies. FDA does not plan to develop a formal guidance document, staffers say. However, ODE does plan to develop a number of guidance documents for specific product areas. Some general recommendations for device studies also will appear in a report being finalized by FDA's committee for clinical review, a group of drug center staffers led by Robert Temple, director of FDA's office of drug evaluation I. The Temple group recently completed a report on its review of the device evaluation program. FDA has sent draft copies of the report to all of its device advisory committee chairmen and is in the process of sending letters to the device manufacturers which had applications analyzed by the committee to inform them of the committee's findings. The agency expects to release the report later this year.

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