Unapproved Product Trial Data: To Post Or Not To Post On ClinicalTrials.gov?

Full article reprinted from "The Gray Sheet" - June 29, 2009

Device makers say new clinical trial registration and results reporting requirements should be extended to trials of unapproved products only if the trials were stopped for safety reasons. Read more...

Unapproved Product Trial Data: To Post Or Not To Post On ClinicalTrials.gov?

Full article reprinted from "The Gray Sheet" - June 29, 2009

Device makers say new clinical trial registration and results reporting requirements should be extended to trials of unapproved products only if the trials were stopped for safety reasons.

The National Institutes of Health is drafting regulations that will expand its ClinicalTrials.gov database to cover more medical products and include more types of clinical data, as required by the 2007 FDA Amendments Act. A final regulation is required by September 2010 (The Gray Sheet' April 27, 2009).

But the agency has some unanswered questions. It held a meeting last April and posed questions in a March 23 Federal Register notice to help inform its proposed rulemaking. Comments were due June 22.

Among 10 key questions, the agency asked for input on whether trial results should be submitted for applicable device, drug or biologic trials if the product was ultimately never cleared or approved.

Trial results for approved or cleared products are already required under the law; mandatory reporting of basic results information began last fall.

NIH asked for feedback on "potential advantages and disadvantages to the public and public health" of disclosing trial results for unapproved products.

Device trade group AdvaMed says it supports disclosure of such data "if a trial were stopped prior to approval or clearance for safety issues."

 

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