Thoughts from a Lab Rat

I think I’ve touched on this topic a few times but I’m too lazy to research the last time. As if it’s that difficult to look it up. Anyhow, I’ve got a few people asking about it.
What is a washout?
It’s a period of time where one does not do something. In this case, it’s a period of time where you don’t do another clinical research study. Each clinic operates in a slightly different manner but for the most part, you must wait a minimum of 30 days between investigational drug studies. More specifically, it depends on the type of study you have done and the next study you plan on doing. Most drugs carry a 30 day washout. Certain studies such as radiolabel studies carry a one year washout before you can do another radiolabel study but usually a 30 day washout for a non-radiolabel study.
When does the washout period begin?
Well, each clinic and sponsor will decide. There are two possible scenarios. It may go based on the last dosing of the drug or it may go based on the last participation date of the study which means out-patient and or phone call. Again, this depends on the clinic and or sponsor of the next study you participate in.
Who is responsible for enforcing washouts?
Why that would be you! I recommend keeping a log of the studies you participate in, the dates and the drugs involved. It’s good information to have in order to make sure you don’t violate the washout rules and to make sure you don’t do the same study twice. Most sponsors do not allow participants to do the same study drug more than once. While they will eventually figure it out, it’s better to avoid it all together when you are researching studies to participate in.

It all starts with the first study. First of all, doing studies is not for everyone. Obviously, people who are squeamish about needles probably should stay away. My biggest recommendation is that you find a short study, less than a week so you can test the waters. By doing a short study, you will be able to see how the process works, how it feels to have 10 to 20 blood draws in a day and how it feels to be secluded from society. If you find that you don’t like how things are going, I do recommend at least finishing the study. A lot of hard work goes into putting a study on and while yes, you do have the right to quit a study at anytime, for any reason, once you have started taking the study drug, the safest thing to do is to finish out the study. If you do ask to be dropped from a study early, the study doctor will typically ask you to stay for at least one night to make sure that the study drugs are not having any adverse side-effects. Again, this is for your safety.

So, what should you expect during your first study? A lot of what happens during the study takes place at the screening. You will usually have ECG’s, vital signs, blood draws and examinations by the study doctor. Depending on the study, there may be additional procedures such has heart monitors, urine collection and position restrictions. All of the study procedures are outlined in the informed consent. Chat with some other people at the screening. Chances are, many of the other people there have done a study or two and can share some of their experiences. It’s usually not as bad as many people think it is. Most people who think being a research subject is dangerous or freaky probably have never done a study before. Of course, the media and film portrayals don’t help. Sure, things do happen but as long as you are truthful while enrolling in a study, you will minimize most risks.