hey guys today we're talking randomized vers observational studies EC RG play
the intro hey guys EC RG here today we're talking the
difference between observational studies and randomized studies now these are
quite different as you can tell by the name and there's an important
distinction here because clinical trials what most people know about are the
randomized controlled clinical trials but there is also some use for
observational studies so we're going to talk about the key differences here
today in this video and some of the things you want to know when determining
when looking at the difference between the two so what is an observational
study so an observational study is really a study where the independent
variable if you remember back to basic science at the variable that the
scientist controls is not under the control the researcher because of either
logistical constraints or there could be some ethical reasons like some things
you can't do and it's out of the control of the investigator so the next thing
you would do would be an observational study and one common observational study
that happens is when you're studying the possible effect of treatment on subjects
where the assignment of subjects into a treated group versus a control group is
outside the control the investigator and the reason why you would want to do this
is particularly because so just as an example of an observational study or why
you couldn't run a randomized control trial is let's say you were studying
abortion on breast cancer rates now for a randomized control study you would
separate the Group one been to the ones that would receive
abortions and one group that would not receive abortions and see their chances
of breast cancer well an investigator can't make one group of women have
abortions you can't do that for ethical reasons so he would just have to observe
like an an observational study the incidence of breast cancer for those
that receive abortions you would have to look at the population of people that
receive abortions and then look at their breast cancer rates and then he we have
to compare that with those that receive abortions versus their breast cancer
rates so he would have to observe that he couldn't you know make people get
abortions so that's just one reason why you know why the investigator could not
you know manipulate the in the variable there so there are many types of
observational studies that you may remember from statistics class you're
gonna have case control studies cross-sectional studies longitudinal
studies ecological studies there are many different types of observational
studies and we're not gonna go to in depth there about the different types
just wanted to give an overview of observational studies and you know
observational studies aren't necessarily there to make definitive statements like
randomized controlled trials would be they are there to you know they can
provide information on real-world practice and uses of different things
and they can detect signals and they're usually there to determine what you
would want to study in the future through a randomized clinical trial
because that that that can show causality observational will just you
know be an intro to what you would want to study later on you can they can help
formulate a hypothesis etc etc so that's an observational study now we're going
to talk about the randomized controlled clinical trial
so basically the randomized controlled clinical trial is the gold standard when
it comes to trials and this is because it reduces for all types of confounding
variables and biases along the way with being with the subjects being randomized
and you know double blinding and things of that nature they reduce confounding
variables and bias so basically the flow is you figure out what you want to test
normally an intervention of some sort and then you group you randomize
patients into one group that's going to receive the intervention or one group
that's gonna either receive the current standard of care or a placebo depending
on what the disease you're studying is and so so then you know that's this is
basically the basic form and then you will analyze the difference using some
measurement at the end and see which one is better so that's basically the basic
interpretation of it so why you would do a randomized
controlled clinical trial like I said before is companies will use a
randomized controlled clinical trial to submit to the FDA in order to get their
drug approved and in order for your drug to be improved you have to show that it
is as good or better than the current standard of care on the market and
companies will use this in order to get it approved by the FDA and to make it to
the market in the hopes that doctors will prescribe it or whoever will
prescribe it and their patients will use it
and hopefully will increase their quality of life or something of that
nature or cure the disease now we'll get into whether they will cure or just
increase the quality of life later because that's not really the topic of
this video but basically if you watch my last video
on the different phases that's what a clinic controlled clinical trial is a
randomized clinical trial is and you know there are some disadvantages to
running a randomized controlled clinical trial one can be how expensive it is and
if you watch my last video we talked about all the different phases you have
to bring it through a preclinical phase 1 phase 2 phase 3 and sometimes phase 4
so these obviously cost a lot of money millions of dollars and also it takes
time and you don't know if you're gonna get a return on investment if your
sponsor of pharmaceutical company you don't know because they take so much
time and you know by the time you're halfway through you've already spent so
much money in time that a lot of them don't make it through all the way
through the process they will they will quit beforehand because they just
depleted so many resources and so a lot of drugs don't make it to market for
that reason so it's important to keep in mind these things take time they take a
lot of years they have multiple hands touching them and you know it's a big
effort to get a drug through a randomized controlled clinical trial and
one to be applauded if it makes it through the process it's a very rigorous
process and you know you got to be flexible along the way with that so
that's basically the purpose of this video to talk about the difference
between the randomized controlled clinical trial and the observational
study so if you guys have any questions comment them down below we'll do our
best to answer them thank you so much for liking this video and don't forget
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another video and as always guys email us at elite clinical group at gmail.com
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