Giving and taking: ethical treatment assignment in controlled trials

1. Howick, J . Questioning the methodologic superiority of ‘placebo’ over ‘active’ controlled trials. Am J Bioethics 2009; 9: 34–48.
Google Scholar | Crossref | Medline | ISI2. Senn SJ. Placebo misconceptions. Am J Bioethics 2009; 9: 53–54.
Google Scholar2. D’Aquila, RT, Hughes, MD, Johnson, VA, Fischl, MA, Sommadossi, JP, Liou, SH, et al. Nevirapine, zidovudine, and didanosine compared with zidovudine and didanosine in patients with HIV-1 infection. A randomized, double- blind, placebo-controlled trial. National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group Protocol 241 Investigators. Ann Intern Med 1996; 124: 1019–1030.
Google Scholar | Crossref | Medline | ISI3. World Medical Association (2013). Declaration of Helsinki: ethical principles for medical research involving human subjects. The World Medical Association, Inc. BP 63 01212 Ferney-Voltaire Cedex, France.
Google Scholar4. Howick J (personal communication). No placebos (in trials when we have something better), Please: a plea to return to the original Declaration of Helsinki.
Google Scholar5. Senn, SJ . Ethics of clinical trials from Bayesian perspective: society’s role is important. BMJ 2003; 326: 1456–1457.
Google Scholar | Crossref | Medline6. Evans I, Thornton H, Chalmers I and Glasziou P. Testing Treatments. London: Pinter and Martin, 2011.
Google Scholar7. Gillies, K, Chalmers, I, Glasziou, P, Elbourne, D, Elliot, J, Treweek, S. Reducing research waste by promoting informed responses to invitations to participate in clinical trials. Trials 2019; 20: 613–613.
Google Scholar | Crossref | Medline8. Vist GE, Bryant D, Somerville L, Birmingham T and Oxman AD. Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate. Cochrane Database Syst Rev 2008; 2008: MR000009.
Google Scholar9. Chalmers, I . Adverse effects of statins: Randomized, placebo-controlled withdrawal/discontinuation trials to assess possible adverse effects of statins. BMJ 2014; 348: g3306–g3306.
Google Scholar | Medline10. Herrett, E, Williamson, E, Brack, K, Beaumont, D, Perkins, A, Thayne, A, et al. on behalf of the StatinWISE Trial Group . Statin treatment and muscle symptoms: series of randomised, placebo controlled n-of-1 trials. BMJ 2021; 372: n135–n135.
Google Scholar | Crossref | Medline11. Senn, SJ . The misunderstood placebo. Appl Clin Trials 2001; 10: 40–46.
Google Scholar12. Senn, SJ . Ethical considerations concerning treatment allocation in drug development trials. Stat Meth Med Res 2002; 11: 403–411.
Google Scholar | SAGE Journals | ISI13. Haygarth J. Of the Imagination, as a Cause and as a Cure of Disorders of the Body: Exemplified by Fictitious Tractors, and Epidemical Convulsions. Bath: R. Crutwell, 1800.
Google Scholar14. Booth CC. John Haygarth FRS (1740–1827). JLL Bulletin: Commentaries on the history of treatment evaluation. See www.jameslindlibrary.org/articles/john-haygarth-frs-1740-1827/) (2002, last checked 17 September 2021).
Google Scholar15. Wartolowska K, Beard DJ and Carr AJ. The Use of Placebos in Controlled Trials of Surgical Interventions: A Brief History. JLL Bulletin: Commentaries on the history of treatment evaluation. See www.jameslindlibrary.org/articles/use-placebos-controlled-trials-surgical-interventions-brief-history/ (2017, last checked 17 September 2021).
Google Scholar16. Page MJ, Higgins JPT, Clayton G, Sterne JAC, Hrobjartsson A and Savovic J. Empirical evidence of study design biases in randomized trials: systematic review of meta-epidemiological studies. PLoS One 2016; 11: e0159267.
Google Scholar17. Kaptchuk TJ. A Brief History of the Evolution of Methods to Control Observer Biases in Tests of Treatments. JLL Bulletin: Commentaries on the history of treatment evaluation. See www.jameslindlibrary.org/articles/a-brief-history-of-the-evolution-of-methods-to-control-of-observer-biases-in-tests-of-treatments/ (2011, last checked 17 September 2021).
Google Scholar18. Kaptchuk TJ (2011). A brief history of the evolution of methods to control observer biases in tests of treatments. JLL Bulletin: Commentaries on the history of treatment evaluation (https://www.jameslindlibrary.org/articles/a-brief-history-of-the-evolution-of-methods-to-control-of-observer-biases-in-tests-of-treatments/.
Google Scholar19. Chalmers I. Why the 1948 MRC trial of streptomycin used treatment allocation based on random numbers. JLL Bulletin: Commentaries on the history of treatment evaluation. See www.jameslindlibrary.org/articles/why-the-1948-mrc-trial-of-streptomycin-used-treatment-allocation-based-on-random-numbers/ (2010, last checked 17 September 2021).
Google Scholar20. Marušić A and Fatović-Ferenčić S. Adoption of the Double Dummy Trial Design to Reduce Observer Bias in Testing Treatments. JLL Bulletin: Commentaries on the history of treatment evaluation. See www.jameslindlibrary.org/articles/adoption-of-the-double-dummy-trial-design-to-reduce-observer-bias-in-testing-treatments/ (2012, last checked 17 September 2021).
Google Scholar21. CRASH Trial Collaborators . Effect of intravenous corticosteroids on death within 14 days in 10,008 adults with clinically significant head injury. Lancet 2004; 364: 1321–1328.
Google Scholar | Crossref | Medline | ISI22. Senn SJ. Are placebo run ins justified? Br Med J 1997; 314: 1191–1193.
Google Scholar23. Chalmers I and Glasziou P. Protecting the public from the adverse effects of confused research ethics. 2021 JRSM (in press).
Google Scholar24. Senn. Statistical Issues in Drug Development. 1st ed. Chichester: Wiley, 1997.
Google Scholar

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