tag:blogger.com,1999:blog-1474751880645498536.post8349388328908239806..comments2023-10-10T10:14:36.340-04:00Comments on Medical Evidence Blog: Are Merck and Schering-Plough "enhancing" the ENHANCE data?Scott K. Aberegg, M.D., M.P.H.http://www.blogger.com/profile/17564774546019869201noreply@blogger.comBlogger5125tag:blogger.com,1999:blog-1474751880645498536.post-32014123313173121582007-11-30T18:42:00.000-05:002007-11-30T18:42:00.000-05:00Echoing the anonymous comment above is this perspe...Echoing the anonymous comment above is this perspective in this week's NEJM:<BR/>http://content.nejm.org/cgi/content/extract/357/22/2217<BR/>Which also focuses on this newly passed legislation.Scott K. Aberegg, M.D., M.P.H.https://www.blogger.com/profile/17564774546019869201noreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-60375483814634972802007-11-28T14:35:00.000-05:002007-11-28T14:35:00.000-05:00Sir or Madam - that is an excellent comment. Very...Sir or Madam - that is an excellent comment. Very informative! Thank you!Scott K. Aberegg, M.D., M.P.H.https://www.blogger.com/profile/17564774546019869201noreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-37630031574383177452007-11-28T12:36:00.000-05:002007-11-28T12:36:00.000-05:00Regarding your suggestion re: ClinicalTrials.gov, ...Regarding your suggestion re: <A HREF="http://clinicaltrials.gov" REL="nofollow">ClinicalTrials.gov</A>, Section 801 of <A HREF="http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf" REL="nofollow">Public Law 110-85</A>, enacted on Sept 27, 2007, enhances this NIH-operated clinical trials registry and adds a mandatory summary results reporting provision, which would require posting of summary data from clinical trials testing FDA-approved drugs -- such as Zetia, Zocor, and Vytorin -- and FDA-approved or cleared medical devices within a year of completion (or up to two years if the trial will be used to support a "new use"). Data to be reported include demographic and baseline characteristics of patient sample, primary and secondary outcomes, and serious and frequent adverse events. Failure to comply could result in civil monetary penalties or withholding of Federal grant funds. When the new law is implemented, it should increase transparency in clinical research and mitigate common data reporting issues, such as the ENHANCE case. (See <A HREF="http://prsinfo.clinicaltrials.gov/fdaaa.html" REL="nofollow">http://prsinfo.clinicaltrials.gov/fdaaa.html</A> for more information.)<BR/><BR/>NOTE: The primary outcome measure listed in the ENHANCE trial registration (<A HREF="http://clinicaltrials.gov/ct2/show/NCT00552097" REL="nofollow">http://clinicaltrials.gov/ct2/show/NCT00552097</A>), which was only submitted recently (Oct 31, 2007) is: "Change in ultrasound-determined average carotid artery intima-media thickness (IMT) on a per subject basis between baseline and endpoint. [ Time Frame: 24 months ]" The other three endpoints are listed at ClinicalTrials.gov as <I>secondary</I> outcome measures.<BR/><BR/>According to the <A HREF="http://www.forbes.com/2007/11/19/zetia-vytorin-schering-merck-biz-health-cx_mh_1119schering.html" REL="nofollow">Forbes article</A>, "Schering and Merck did not list the trial on the government Web site clinicaltrials.gov, ... until asked by Forbes.com about its absence." <BR/><BR/>However, the International Committee of Medical Journal Editors (<A HREF="http://www.icmje.org/" REL="nofollow">ICMJE</A>) , which include <I>NEJM</I>, <I>JAMA</I>, <I>Annals of Internal Medicine</I>, <I>BMJ</I>, and <I>Lancet</I> issued a Clinical <A HREF="http://www.icmje.org/clin_trial.pdf" REL="nofollow">Trials Registration Policy</A> in 2004 that requires, "as a condition for consideration for publication," that clinical trials to be registered "at or before the onset of patient enrollment." The ICMJE stated in a subsequent <A HREF="http://www.icmje.org/clin_trialup.htm" REL="nofollow">editorial</A> that it would "consider for publication ongoing trials that are registered before September 13, 2005." According to its registration record at ClinicalTrials.gov, ENHANCE was initiated in June 2002 and completed in <B>April 2006</B>, but was registered in <B>October 2007</B>. Were the sponsors ever intending to publish the full results in a peer-reviewed journal article?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-48104867624775333692007-11-27T16:14:00.000-05:002007-11-27T16:14:00.000-05:00Yes, it is an intentional pun. And besides, missp...Yes, it is an intentional pun. And besides, misspellings and typos don't undermine story lines or logic.Scott K. Aberegg, M.D., M.P.H.https://www.blogger.com/profile/17564774546019869201noreply@blogger.comtag:blogger.com,1999:blog-1474751880645498536.post-77489133973003945872007-11-27T14:59:00.000-05:002007-11-27T14:59:00.000-05:00Pssst, it's "siMvastatin," not "siNvaststin," unle...Pssst, it's "siMvastatin," not "siNvaststin," unless you're making some sort of pun. This is an interesting story, but I can't bother reading your take on it if you can't spell the name of the drug correctly.Anonymousnoreply@blogger.com