Clinical Trial Design: Part 2

Page 2, almost done. Promise.

Types of Variables

Good experiments have independent and dependent variables. The independent variable is the treatment. The dependent variable is the result or what they are measuring.

Again, the idea is to keep as much as possible the same between our two or more groups. The groups are generally treatment(s) and control. Control groups get the sham ‘treatment’. The only things that ideally should be different among the groups are the independent variables, treatments.

In reading a study you can tell what your chances are of getting a treatment by checking how many different treatments they are looking at. For example, if there are three, different quantities of stem cells they are inserting and only one control group, you have a 75% chance of getting a treatment.

The Statistics

After the experiment is done, the researchers do statistical magic and find out if there was a real effect of the treatment. They want to see if what happened could have happened by chance. If there is little chance that it did happen by chance, they are that much closer to finding an effective treatment. At least in the studies I am interested in, people in the control group are offered the effective treatments when the experiments are done. They are not out of luck.

Remember, the medical research we may volunteer for has been done many times on laboratory animals. Unless you are very brave and sign up for a phase 1 clinical trial, other people have had the procedure before you. Real research is published in reputable journals. Ask where their initial findings were published. If you don’t get a decent answer, be very cautious. If you do get a journal reference and cannot interpret it, send it along. I don’t guarantee we will get it right, but we will give it the old, college try.

Size of the study

Also, in research there is such a thing as a cohort. A cohort is a group of subjects going through the same treatment pretty much at the same time. Phase 1 cohorts are small, maybe 7 or 8 people, but phase 2 cohorts may be a couple of dozen people. There are more people in the higher phases. If you are told you are the only one or one of just a few, be suspicious.

Those are some of the things that legitimate research have as well as a couple of extra tips on making sure you are looking at a legitimate study. The information is pretty dry but having access to it is better than falling for a bogus offer and being rendered blind. That is, after all, what we are all trying to avoid!

Just remember, caveat emptor. Check things out very well first.

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