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Old 08-07-2009, 10:52 PM
LindaH LindaH is offline
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Join Date: Aug 2006
Posts: 230
15 yr Member
LindaH LindaH is offline
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Join Date: Aug 2006
Posts: 230
15 yr Member
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There are also some new regs on reporting clinical trial results to clinicaltrials.gov, including trial results
Here are some references :
11/09/07 FACT SHEET (Available at http://prsinfo.clinicaltrials.gov/)
Registration at ClinicalTrials.gov:
"As required by Public Law 110-85, Title VIII
On September 27, 2007, a U.S. law was enacted that expands the types of clinical trials that must be registered in ClinicalTrials.gov, increases the number of data elements that must be submitted, and also requires submission of results data."

On http://prsinfo.clinicaltrials.gov/re...finitions.html
a draft of the basic results data elements are defined for the results database. As of July 2009 the data base doesn't seem to be up and runniing yet, however results can be included in the existing clinicaltrials.gov record

Also according to the FDA Amendments Act (FDAAA), Section 801: “Basic Results”Provisions [Source: Pub L. 110-85, Sec. 801, adding new 42 U.S.C. 282(j)(3)(C)]‘‘(C) BASIC RESULTS.—
"Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall include in the registry and results data bank the following elements for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act and devices that are cleared under section 510(k) ofthe Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act:

at: http://prsinfo.clinicaltrials.gov/FD...sicResults.pdf
the basic result elements that should be included are described, but it appears to be only for drugs that have been FDA approved, so no data on failures?
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girija (08-08-2009), olsen (08-08-2009), pegleg (08-07-2009)