I'm thinking of things like antibiotics for meningitis or tuberculosis, or thiamine for Wernicke-Korsakoff syndrome. In those cases the magnitude of the treatment effect might have been so great that it would have been unethical to assign subjects to a placebo group. However, I couldn't find any sources to attest that randomized control trials were never done in relation to those treatments.

I'm referring to treatments trialled in a time and place in which randomized control trials were an option.

  • 3
    $\begingroup$ there were no clinical trials in olden days $\endgroup$
    Commented Jun 10, 2015 at 4:38
  • $\begingroup$ In Japan, the government approved some chinese medicine without clinical trials, even if the system to approve drugs has been already established for a decade by referring to the system by western countries. The medicine is still covered by insurance. $\endgroup$
    – 243
    Commented Jun 10, 2015 at 6:32
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    $\begingroup$ Most surgical medical treatments fall into this category. For example, patients with acute appendicitis who do not receive an appendectomy will die from peritonitis. Also, it is difficult to obtain ethics approval for an RCT where you open up a person and then sew them back up simply as a sham treatment. $\endgroup$
    – mdperry
    Commented Jun 10, 2015 at 10:39
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    $\begingroup$ Often new treatments are compared against best available treatment rather than placebo to alleviate ethical issues. $\endgroup$
    – Rory M
    Commented Jun 10, 2015 at 11:50

1 Answer 1


In recent years, clinical trials are all necessary. You have to have the randomised control To make sure it isn't a placebo effect. If and only if the drug seems to be super effective will they cut the randomised control short and give the real drug to everyone.

Sadly, while it may seem unethical, there was a cancer treatment that two cousins got into. The normal treatment guaranteed death, while the new drug actually had people practically bouncing off their death beds. One got the placebo - in this case normal treatment since it's unethical to not at least give standard care - and the other got the drug. The drug worked so well, the doctors tried to push to cut the trial short but they wouldn't and the one on the normal treatment died.

This drug was PLX4032.

blogspot uproar

clinical trial information

NYTimes article

So to my knowledge about clinical trials, no trial has been able to skip that stage. It's actually Called Phase III testing of the drug, followed by Phase IV which is administration to the public. It can, however, be shortened if it is promising enough.


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