On the Short Regulatory Horizon

September 6, 2011 – 8:08 AM | By Mark McCarty | No comments yet


As the saying goes, there are things we know we don’t know, but here are three things we do know, namely guidances that will affect device makers. One of these might have the effect of making some clinical trials less expensive, but another could put the brakes on provider training even in first-in-human studies unless the sponsor is willing to roll out a training protocol for all physician users in the post-market setting.

FDA to put brakes on surgeon training?

FDA issued a mid-August draft guidance for device clinical trials indicating antipathy toward a sponsor’s training of doctors in trials unless the sponsor is willing to do the same for doctors in routine practice. This would seem to apply even to studies engaged prior to the pivotal clinical trial.

The draft also reintroduces the boilerplate pertaining to the standard of “least burdensome,” which had been omitted from a number of documents issued by the agency over the past 18 months. This guidance defines the phrase as “a successful means of addressing a pre-market issue that involves the most appropriate investment of time, effort and resources on the part of industry and the FDA,” seemingly adding FDA to the bodies subjected to the least burdensome requirements.

NIH updates 1995 financial conflict guidance

The Department of Health and Human Services recently cut in half the threshold for reports on potential financial conflicts of interest (FCOI), but it appears that publicly funded research institutions will not have to post all financial relationships on a website, but make the information available when requested.

The Aug. 23 NIH statement indicates that the new threshold for determining “significant financial interest” will for the most part be reset from $10,000 to $5,000, and a subsequent passage states that before an institution spends any government monies, that institution must “post on a publicly accessible web site information” on significant financial interests “of senior/key personnel” for whom a conflict might be imputed, seemingly eliminating the need to routinely post information online for all clinical researchers at that institute.

FDA draft guidance for risk-based clinical trial monitoring

FDA released a late August draft guidance for clinical trial monitoring that opens the door to less granular monitoring of clinical trials via the “greater use of centralized monitoring methods.”

FDA says there is a consensus regarding risk-based monitoring processes that “are more likely to ensure subject protection and overall study quality” by zeroing in on “the most critical data elements,” rather than on “routine visits to all clinical sites” in pursuit of “100% data verification.”

Among the features of centralized monitoring cited by FDA is the use of data checks to ensure the completeness of data from case report forms, but the guidance also states that sponsors should consider identifying higher-risk sites for on-site monitoring as well. The draft recommends further that sponsors or CROs use statistical analyses “to identify data trends not easily detected by on-site monitoring.”

Several exceptions pertain here, including trials with adaptive designs, trials that call for “multiple device placement,” and trials that are not blinded.


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