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Let us go back to the golden age of simple clinical trials & get rid of    big, motivated RCTs.

Posted in Uncategorized, tagged , , , , , , , , on April 19, 2026|

Very soon, blogs and independent writing will be the only source of unadulterated truths. One such article is shared here written by Adam Kroetsch , formerly in the FDA

A review and comments

The above article compellingly recounts how clinical trials evolved from ad-hoc, investigator-led efforts in the mid-20th century to the bureaucratic behemoths of today. It highlights the “golden age” of the 1980s-1990s, when academic “trialists” pioneered large simple trials like ISIS and GISSI. These mega-trials enrolled tens of thousands with minimal protocols ,one-page forms, no routine monitoring or source data verification (SDV), proper randomization, and focus on clinical hard endpoints and mortality delivering transformative, low-cost evidence on treatments like streptokinase and Aspirin.

The decline followed the rise of Contract Research Organizations (CROs) in the 1990s, global Good clinical practice -GCP guidelines (1996), and FDA missteps. Trials are now industrialized and bureaucratized: extensive on-site monitoring, exhaustive adverse event reporting, data audits, and risk-averse compliance layers inflated the costs (rising 10% annually). Academic and NIH-funded large trials plummeted .Pharma shifted to smaller, often useless biomarker-driven studies instead of clinical outcome. (Eg Drug X reduce NT-pro BNP by this,and it is crowned in glory ). The irony is ,the trialists are crying “foul” at GCP, and call it unscientific as they interupt the industry.

Who is responsible for this chaos?

Primarily commerce and greed in a profit-driven ecosystem .Alos pharma’s risk aversion and demand for speed and volume. Other factors were, heavily empowered CROs, Perverse incentives and Industry balance sheets, dictated the how science should behave. No surprise , true academics and genuine funders retreated amid prohibitive costs.

Final message

GCP  is not a taboo subject,  as some non- academic forces would like to envisage. Let us bring back the golden age of simple trials—even observational ones will bring the truth when done appropriately .Let us stop this big commercialised RCT nonsense  with ultier motives.

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A new “Null Hypothesis” in medical research !

Posted in bio ethics, medical quotes, Two line sermons in cardiology, tagged , , , , , on December 21, 2014| 1 Comment »

Picture4

After nearly three decades of , treating patients , teaching students and little involvement in research , created a new definition for null hypothesis in medical research  !

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You are a foolish cardiologist . . . don’t corrput young minds !

Posted in bio ethics, cardiology-ethics, Land mark articles in cardiology, medical quotes, tagged , , , , , , , , , , , on November 26, 2013| Leave a Comment »

In one of my  meetings , I told a small gathering  , that regular exercise can shrink atherosclerotic plaques and regress CAD. I also quoted , a recent  large  study which  has proven this fact convincingly !

I concluded, simple  exercise  and other life style changes,risk factor correction  may convert a 90% lesion to 70 or even 50 % . I stressed the importance of this study and asked my colleagues to avoid misuse of  Angioplasties .

When many  seemed to agree with me , one  angry  Interventional cardiologist questioned me, and  asked  the name of the  study, and in which journal  it came , What was quality of the paper ?

evidence based medicine ebm experince

I told him , It is an Imaginary study done  in my back yard . It never got published in print. You may call it as E-journal* , not exactly though.It is not available in any websites , but located in the  biological servers, and  neuronal circuits as digital imprints in learned brains !

*Journal of experience

You may call it , a scientific  forgery , to quote a non-existent study,

“But this study  benefits whole lot of my  patients”.

He was amused , and became agitated !

He told over the mike , “You are making  foolish statement. . . don’t corrupt young minds” !

May be , he is true !

I asked him to be calm and  requested  to listen to another study which I was about  to quote  . . .

He couldn’t sit any more  and rushed  out of the hall !

Final message

We  are ready to believe all those  rubbish stories about a fourth  generation   self disappearing BVS that is  able to scaffold a coronary artery and maintain a MLD by 2.5mm  and TVR by 20 % and prevent near MAZE  at 30 days  by 9 % and improve long term survival  by 6 months at  the cost of 100, 000 Rs  per month  .Only to realise, it may be a farce  . . .  5 years down the lane !

How to cleanse the darkened face of science ?

When falsehoods come with evidence and harm people , Good deeds can  be preached without evidence to save our fellow human beings !

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Modern medical quotes : Medical research

Posted in Uncategorized, tagged , , , , , on June 18, 2012| Leave a Comment »

                                           Essential qualification for becoming a great medical  researcher  is  the    “Fine art of  mis-interpretating  data “                                                     Venkatesan sangareddi MD .Chennai .India

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When every one is blinded . . . who shall awake medical research ?

Posted in cardiology-ethics, tagged , , on February 29, 2012| Leave a Comment »

Blindness  brings  doom to most life situations , paradoxically it is supposed make us wiser in medical research .

We are made  to  believe , the shrewdness and the accuracy of  a study is directly related to the  degree of blindness .

Is blindness  such a great thing ?

The fact that medical research requires  tight  blindness  for  maintaining  truthfulness  ,    implies  there is a  huge   potential   for contamination  by vested  vision .

Our experience suggest  the purpose of blinding a study has entirely a different meaning in today’s world.

Telmisartan  is non inferior to  Ramipril  proved  by a double blinded RCT screams a headline in a popular journal !

 

Some of the definitions of blinding

Single blinded study

Patient does not know  . . . doctor knows

Double blinded  study

Both the  patient  the doctor  do not know what is the study the researchers knows it .

Triple blinded study

The  Researchers , the doctors and the patients   . . . no one knows what they are doing . Then who will know it ?

Please  be  reminded ,  few powerful men are always awake  to  manipulate the study.

Other forms of blindness (Cortical blindness !)

Who decides  which drug to be compared to which  drug   . . .  we are blinded

Who decides in which country the study  is to be  done  . . .   we are blinded

Who  appoints the principal investigator  . . . we are blinded

Who is steering the steering committee   . . . we are blinded

Who is going to  liaison with the journal editors for publishing the study   . . . .we are blinded

For the practicing doctors  the  blindness often  continues   even  after publishing the trial as vital information are with held.

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What is the purpose of publishing “Limitations of the study ” in original papers

Posted in Cardiology - Clinical, Cardiology -Interventional -PCI, cardiology -Therapeutics, Cardiology -unresolved questions, cardiology-ethics, tagged , , , , , , on July 22, 2011| Leave a Comment »

“Limitations of a study”   column appear in scientific articles  because . . .

  1. It  offers   lame excuses
  2. It  informs us  ,  not to get  fooled by  their  finding  .It could  be terribly wrong
  3. The editors won’t publish the paper  without this customary paragraph!
  4. Judge yourself . . . we are transparent !
  5. No study is 100% perfect . Just to make sure the readers are aware of it.

I fail to understand , why even  good articles are rejected for minor  errors  in methodology by many   journals.

Meanwhile ,  how on this earth it’ s  possible  ?   for  some articles to  appear in  top journals ( with questionable conclusions )  embellished
with   major errors in methodology ,  but has  a proud declaration and confession about the  flaws  of the study  in the “Limitations of study” column !

So , in this  modern scientific world  ,  it suggests to me ,  one can  can write whatever  you think as science , as long as  you  declare it and able to impress the editors  to  shift the errors into  limitations column ,  you  are likely to be excused  and also  rewarded !

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What are the fundamental difference between randomised and observational studies?

Posted in cardiac surgery, tagged , , , , , , , , , , , , on December 7, 2009| Leave a Comment »

What are the fundamental  difference between randomised  studies and observational studies ?

New discoveries come from shrewed  observations made in bedside or labside  while ,  randomised studies evaluate these discoveries for it’s effectiveness or futileness  .

Let us realise ,  RCTs   primarily  never  contribute to  generation of  original  concepts or discoveries  ! .It is a  statistical tool to assess an observation .

Click below to reach the excellent knowledge  source on above  the issue .

PLoS Medicine: Observational Research, Randomised Trials, and Two Views of Medical Science

The fact that  observational studies are done with open eyes &  mind ,  it is  obvious it  demands  intense conceptualization and thinking .
Blinded studies  are  mechanical studies . It is pure statistical research . It requires  no thinking  , medical  mind , in fact one can do it with eyes closed as it is a strict protocol driven  , even a  non medical men  can do a  medical research , while it needs a  alert mind to do a observational study .

Observational studies , especialy  when done retrospectively  has  zero bias  as the case selection and  the potential intervention are completed even before the research question  is raised. In fact many of the  greatest medical breakthrough comes from retrospective analysis. Of course this has to be proved prospectively  preferably in a randomised fashion.

So , we the medical professionals ,  shall  do great observational  research with open eyes and mind and let the  the statisiticins do the outcome analysis blind folded .

If the core medical professionals are bothered more about  randomised blinded  studies ,which is  meant only for evaluation purposes , the  future of intellectual  medical research is  going to be in jeopardy!

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