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Phase IV non-inferiority trials and additional claims of benefit.
Bernabe RD, Wangge G, Knol MJ, Klungel OH, van Delden JJ, de Boer A, Hoes AW, Raaijmakers JA, van Thiel GJ. Bernabe RD, et al. Among authors: wangge g. BMC Med Res Methodol. 2013 May 30;13:70. doi: 10.1186/1471-2288-13-70. BMC Med Res Methodol. 2013. PMID: 23721202 Free PMC article. Clinical Trial.
Should non-inferiority drug trials be banned altogether?
Wangge G, Klungel OH, Roes KC, de Boer A, Hoes AW, Knol MJ. Wangge G, et al. Drug Discov Today. 2013 Jun;18(11-12):601-4. doi: 10.1016/j.drudis.2013.01.003. Epub 2013 Jan 14. Drug Discov Today. 2013. PMID: 23328201
Regulatory scientific advice on non-inferiority drug trials.
Wangge G, Putzeist M, Knol MJ, Klungel OH, Gispen-De Wied CC, de Boer A, Hoes AW, Leufkens HG, Mantel-Teeuwisse AK. Wangge G, et al. PLoS One. 2013 Sep 5;8(9):e74818. doi: 10.1371/journal.pone.0074818. eCollection 2013. PLoS One. 2013. PMID: 24040346 Free PMC article.
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