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Dear Stephanie, Possibly the best source of your answer is the scathing US Government Accountability Office (GAO) Report on the FDA to the US Congress in July 2010: New Drug Approval: FDA's Consideration of Evidence from Certain Clinical Trials http://www.gao.gov/new.items/d10798.pdf You will find loads of examples in that report. You can also find some good examples from the Draft FDA guidance to industry on non-inferiority clinical trials: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM202140.pdf Finally, there was a very good recent 2011 review of the subject from the Clinical Trials Journal: Through the looking glass: Understanding non-inferiority http://www.trialsjournal.com/content/12/1/106 Regards, Ash >________________________________ >From: Douglas Badenoch <[log in to unmask]> >To: [log in to unmask] >Sent: Monday, 14 November 2011, 13:47 >Subject: Re: Noninferiority trials > >Hi Stephanie > >I can't oblige with a specific example unfortunately, as the only recent example I have seen looks to be pretty decent quality (fortunately!) > >Question: In obese people (BMI ?30 kg/m2) with diabetes who inject insulin, are 5mm needles, as compared to 8mm, effective at maintaining glycaemic control and acceptable to patients? > >Original paper: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3118929/ > >Blog post about it here: http://www.thediabeteself.net/uncategorized/5mm-needles-may-be-as-good-as-8mm-for-obese-patients-with-type-1-diabetes-or-type-2-on-insulin/ > >However, I was going to suggest that these sorts of examples are a great resource for all of us, so would you be willing to summarise and share your findings with the list? > >Also, and this may be of interest to the list in general, the CONSORT group are collating a Library of Examples (of good reporting practices) in RCTs. > >http://www.consort-statement.org/consort-library/ > >Conflict of interest: I host the above website, though I haven't been asked by anyone to post this message. > >cheers > >Douglas > >Stephanie Chan wrote: >> Hello all, >> >> I'm preparing a lecture for my housestaff next week on how to read noninferiority trials. I would love to hear any examples you may recall of flawed noninferiority trials. Examples might include: >> >> -- A trial in which the experimental intervention was found to be noninferior to the control, but the noninferiority margin was very wide. >> >> -- A trial in which the intervention was noninferior to the control, but the control was little better than placebo. >> >> -- A trial in which noninferiority was found, but there were a large number of drop-outs and cross-overs, minimizing any differences between the groups. >> >> Thanks for your help and input! >> >> Stephanie >> >> >> >> -- /Stephanie Chan, M.D./ >> http://www.evidencebasedmommy.com/ > >