MAJOR CHANGE TO CONTRACEPTIVE CLINICAL TRIALS NECESSARY, PANEL SAYS
An FDA advisory committee is recommending that the agency fundamentally change the way it tests new contraceptives to focus on comparative drug studies.
The agency needs to adopt active control trial standards that pit the proposed drug against an approved contraceptive to determine effectiveness, the Advisory Committee for Reproductive Health Drugs said at a Jan. 23 meeting. Comparing two drugs provides a more accurate assessment of a drug's efficacy than the current agency practice of using historical studies of contraceptives as a baseline for assessment, the committee concluded.
The committee also agreed that premarket trials should focus on efficacy, not safety. It is "virtually impossible" to get adequate and accurate safety data because of the size of the clinical trial necessary to do so, Charles Lockwood, the committee's acting chair, said. Such an approach would "restrict access of new drugs to the market" because of the time and expense involved.
Furthermore, the panel recommended that drug manufacturers include at-risk populations in their contraceptive testing, such as smokers and women with body-mass indexes above 35. This "real world testing" will provide more accurate results about a drug's efficacy, but will lead to much larger clinical trials, Lockwood said.
The FDA is using the meeting to help craft a new guidance for contraceptive clinical trials. The agency is trying to determine what information is necessary prior to product approval for marketing and what should be required postapproval, an agency briefing document said.
The FDA is doing an "enormous disservice to women" by using outdated studies to estimate proposed drugs' efficacy, advisory committee member Diana Petitti, a senior adviser at Kaiser Permanente Southern California, said. "The time has come" for the agency to drop historical trials, Bruce Stadel, another committee member, added.