Clinical Trials and randomization
Monday, February 23rd, 2009Randomization simply means grouping people together who are very similar. This means that the group is usually in the same age range, weight range, and have a simlar sickness level. There are many criteria for this grouping which can include things like not smoking and/or drinking or not have other health conditions, etc. In this type of study, participants may be divided into two or more groups. One group takes the placebo for a period of time and the other group takes the real medicine. Then the groups switch so that the group that was taking the placebo now takes the medicine and vice versa.
Unfortunately, there is no minimum sample size or duration. Normally statistics require that the sample size be statistically valid. However, there is a formula to compensate for small samples. I personally am wary of this mathematical manipulation. Also the duration can be an issue as some side effects for exposure to certain things may take some time to manifest.
Lastly, the problem with randomization is not the randomization itself, but the selection of the participants. Clincial trials have what is known as a “protocol”, this document states who should be included and excluded from the study. Participants may not be allowed to take over the counter medications or other prescription medications or even drink alcohol during the study. However when the drug receives approval, it may very well be prescribed to people who drink alcohol or who take other medications and/or have additional health problems. Add to that the fact that doctors prescribe drugs for treatments other than what they were originally studied for. This is known as “off label prescribing”.
Off label prescribing unfortunately is often done for young children. The reason for this is simple, for some reason children react to drugs very differently than adults do, because of this there is a need for pediatric studies. However, no one wants their child to be the guinea pig. As a result if your child gets sick, the end up being the guienea pig for that medicine.
Later I will write what all of this has to do with alternative cures.

