Non-inferiority trials are unethical because they disregard patients' interests

Affiliations

Silvio Garattini et al. Lancet. 2007.

. 2007 Dec 1;370(9602):1875-7.

doi: 10.1016/S0140-6736(07)61604-3. Epub 2007 Oct 23.

No abstract available

Comment in

The ethics of non-inferiority trials.
Soliman EZ. Soliman EZ. Lancet. 2008 Mar 15;371(9616):895; author reply 896-7. doi: 10.1016/S0140-6736(08)60406-7. Lancet. 2008. PMID: 18342675 No abstract available.
The ethics of non-inferiority trials.
Gandjour A. Gandjour A. Lancet. 2008 Mar 15;371(9616):895; author reply 896-7. doi: 10.1016/S0140-6736(08)60405-5. Lancet. 2008. PMID: 18342676 No abstract available.
The ethics of non-inferiority trials.
Chuang-Stein C, Beltangady M, Dunne M, Morrison B. Chuang-Stein C, et al. Lancet. 2008 Mar 15;371(9616):895-6; author reply 896-7. doi: 10.1016/S0140-6736(08)60407-9. Lancet. 2008. PMID: 18342677 No abstract available.
The ethics of non-inferiority trials.
Nunn AJ, Meredith SK, Spigelman MK, Ginsberg AM, Gillespie SH. Nunn AJ, et al. Lancet. 2008 Mar 15;371(9616):895; author reply 896-7. doi: 10.1016/S0140-6736(08)60404-3. Lancet. 2008. PMID: 18342678 No abstract available.
The ethics of non-inferiority trials.
Menten J, Boelaert M. Menten J, et al. Lancet. 2008 Mar 15;371(9616):896; author reply 896-7. doi: 10.1016/S0140-6736(08)60408-0. Lancet. 2008. PMID: 18342679 No abstract available.

EMA's reflection on placebo does not reflect patients' interests.
Bertele' V, Banzi R, Gluud C, Garattini S. Bertele' V, et al. Eur J Clin Pharmacol. 2012 May;68(5):877-9. doi: 10.1007/s00228-011-1175-4. Epub 2011 Dec 2. Eur J Clin Pharmacol. 2012. PMID: 22134525 No abstract available.
Generic and therapeutic substitutions: are they always ethical in their own terms?
AlAmeri M, Epstein M, Johnston A. AlAmeri M, et al. Pharm World Sci. 2010 Dec;32(6):691-5. doi: 10.1007/s11096-010-9429-2. Pharm World Sci. 2010. PMID: 20924677 Review.
A new approach to psychiatric drug approval in Europe.
Barbui C, Bighelli I. Barbui C, et al. PLoS Med. 2013 Oct;10(10):e1001530. doi: 10.1371/journal.pmed.1001530. Epub 2013 Oct 15. PLoS Med. 2013. PMID: 24143137 Free PMC article.
Ethical issues in naturalistic versus controlled trials.
Helmchen H. Helmchen H. Dialogues Clin Neurosci. 2011;13(2):173-82. doi: 10.31887/DCNS.2011.13.2/hhelmchen. Dialogues Clin Neurosci. 2011. PMID: 21842614 Free PMC article.
Do we learn the right things from clinical trials?
Garattini S, Bertele' V. Garattini S, et al. Eur J Clin Pharmacol. 2008 Feb;64(2):115-25. doi: 10.1007/s00228-007-0411-4. Epub 2008 Jan 29. Eur J Clin Pharmacol. 2008. PMID: 18228013 Review. No abstract available.