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medical ethics stastistics www.drsvenkatesan.com

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Of late many drugs are entering the  market  for human  consumption backed up by  Non -Inferiority trials (NIT ) .Few examples.

“The ONTARGET trial: Telmisartan is non-inferior to Ramipril in  New Study Results Published in the New England …”

Feb 20, 2013 – in the New England Journal of Medicine Show Dabigatran Etexilate ... daily was non-inferior to warfarin (p=0.01) in preventing recurrent VTE, …”

What is the logic behind these  Non inferiority trials ?

Why it came into vogue ? 

Do you agree with the concept of NIT ?

I have taken the  privilege  of putting my answer in the title. Believers  of NIT please excuse me.

Reference

Non inferiority drug trial

Non inferiority drug trial 2

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In this world of  evidence based medicine  the  funny bedside vocabulary of  medical statistics   has withstood the test of  time. The following words are liberally used by physicians of all walks of life.

We never bother to find what these words mean to our patients  !

Here is a crude and  wild   numerical attempt to  decode  these words.

  • Always                                    99 %
  • It s a rule                                  95-99%
  • Almost always                       90-95%
  • Very common                       > 90 %
  • Common                                  > 75%
  • Uncommon                            < 30 %
  • Rare                                          < 10 %
  • Very rare                                < 5 %
  • It is an exception                2 -5 %
  • Remote                                   < 2 %
  • Never                                     < 1%

Apart from the above   there two  hugely popular  medical words used over  million times every day in all walks of medical practice.

They are  ” May” and “May not”

The greatness of these words lies  in the fact   it can convey any of the above  10 meanings in a single phrase without any fuss !

Further ,  the words may and may not are numberless un-quantified statistical  jargons that   can convey a deep meaning or  . . . no meaning  depending upon the circumstances !

Doctor ,  is there a possibility of  my stent getting occluded    as i have skipped  the  clopidgrel ,and aspirin for the past two weeks

You may  be at risk  . . . but you may not develop  an heart attack immediately . I would advice you start the drug immediately .

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