3 ms·

> You can retrospectively get the control data for same time frame. This won't br same as placebo but still good. No you can't and no it won't. Clinical study

> You can retrospectively get the control data for same time frame. This won't br same as placebo but still good. No you can't and no it won't. Clinical study protocol documents are often thousands of pages long because they need to describe mundane procedures down to how doctors and nurses are supposed to draw the subjects' blood so that there aren't significant variations between participating hospitals. The point of a control group is to control as many variables as possible and placebos are only a small part of that. Selecting control groups is an entire subfield of modern medicine. Many drugs with much more promising early results that were gathered under nearly ideal conditions (instead of the chaos of a pandemic) have failed hard in third phase trials.

zeku 7y ago
You actually can. I'm a Software Engineer/Data Scientist whatever--and this is a part of my job. You can take the entire case cohort and filter out all of the people who we don't have robust data for. Then find a control cohort who do have all of the things we're looking at and then analyze the data. Yes it would've been better to do a grade A trial from the get go, but these kinds of studies can be done.
- SiempreViernes 7y ago
  Ok, so are you saying you could find a control cohort for the patients in this study? Or are you making the much less useful statement that a proper study is possible?
- akiselev 7y ago
  I've actually worked on clinical trials. Most of the industry has been moving towards preregistering clinical trials so that statistical analyses like the one above can't be used to demonstrate efficacy by using retroactive patient selection criteria that only keeps the most favorable data points (like this paper does, in effect). I'm not arguing with the validity of the statistics, I'm saying it's not enough to fulfill the medical standards for demonstrating drug efficacy. An actual clinical trial protocol needs to be properly designed and coordinated across participating facilities - otherwise it's simply garbage in, garbage out, no matter the quality of the statistical method. Edit: The exception is cases like this where the drug is approved for some uses and doctors in some countries are legally allowed to prescribe it off label using their own judgement of statistical analyses like the one above. However, the issue becomes liability and most doctors will fall back to FDA recommendations that are based on controlled clinical trials.
  - zeku 7y ago
    Yeah, I agree you need a full up to standard clinical trial to really get something like this into the US medical system under normal circumstances. I was just mentioning that things can be learned from this study retrospectively by creating a control group from an EHR. It has validity in the short term for MD's who might begin using this treatment under our fast track system we're using for COVID stuff. If this trial was done at my institution and my team already had all of the paperwork out of the way with regards to the data access we could have something useful in a week or two out the door. So I hope this will be done by someone somewhere, just to save lives in short term.
    - akiselev 7y ago
      My apologies, I misunderstood your previous reply. I'm just afraid that loosening standards in this specific crisis is walking a really fine line. It makes sense during short burn epidemics like ebola where the fatality rate is so skewed, but exposing millions of people to HCQ during an extended highly infectious pandemic, especially without proper screening, is dangerous. Small price to pay if we're talking about something safe like aspirin or if HCQ cuts the CFR in half but if it's only a 10-20% difference, or the effect disappears with a larger sample size, or the mad rush for the drug causes a breakdown in quality control, or the demand deprives people who need it for other reasons - there's a very high chance of worsening quality of life for many people and creating a net negative. What is the fast track system for COVID? I've seen the emergency use authorizations for clinical testing but not any for new treatments other than the usual off label use.

zeku 7y ago

You actually can. I'm a Software Engineer/Data Scientist whatever--and this is a part of my job. You can take the entire case cohort and filter out all of the people who we don't have robust data for. Then find a control cohort who do have all of the things we're looking at and then analyze the data. Yes it would've been better to do a grade A trial from the get go, but these kinds of studies can be done.

SiempreViernes 7y ago
Ok, so are you saying you could find a control cohort for the patients in this study? Or are you making the much less useful statement that a proper study is possible?
akiselev 7y ago
I've actually worked on clinical trials. Most of the industry has been moving towards preregistering clinical trials so that statistical analyses like the one above can't be used to demonstrate efficacy by using retroactive patient selection criteria that only keeps the most favorable data points (like this paper does, in effect). I'm not arguing with the validity of the statistics, I'm saying it's not enough to fulfill the medical standards for demonstrating drug efficacy. An actual clinical trial protocol needs to be properly designed and coordinated across participating facilities - otherwise it's simply garbage in, garbage out, no matter the quality of the statistical method. Edit: The exception is cases like this where the drug is approved for some uses and doctors in some countries are legally allowed to prescribe it off label using their own judgement of statistical analyses like the one above. However, the issue becomes liability and most doctors will fall back to FDA recommendations that are based on controlled clinical trials.
- zeku 7y ago
  Yeah, I agree you need a full up to standard clinical trial to really get something like this into the US medical system under normal circumstances. I was just mentioning that things can be learned from this study retrospectively by creating a control group from an EHR. It has validity in the short term for MD's who might begin using this treatment under our fast track system we're using for COVID stuff. If this trial was done at my institution and my team already had all of the paperwork out of the way with regards to the data access we could have something useful in a week or two out the door. So I hope this will be done by someone somewhere, just to save lives in short term.
  - akiselev 7y ago
    My apologies, I misunderstood your previous reply. I'm just afraid that loosening standards in this specific crisis is walking a really fine line. It makes sense during short burn epidemics like ebola where the fatality rate is so skewed, but exposing millions of people to HCQ during an extended highly infectious pandemic, especially without proper screening, is dangerous. Small price to pay if we're talking about something safe like aspirin or if HCQ cuts the CFR in half but if it's only a 10-20% difference, or the effect disappears with a larger sample size, or the mad rush for the drug causes a breakdown in quality control, or the demand deprives people who need it for other reasons - there's a very high chance of worsening quality of life for many people and creating a net negative. What is the fast track system for COVID? I've seen the emergency use authorizations for clinical testing but not any for new treatments other than the usual off label use.