Thoughts from a Lab Rat

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.

I know many people do it. What am I talking about? Plan B. It’s tough to get into a study sometimes and with the possibility of cancellations, postponements and just not getting into a study, it only seems right to have a backup plan. While it may seem like good intentions, it can backfire.
Let’s say that you signed up to screen for Study A on the 1st and it checks in on the 14th. You then sign up for Study B which screens on the 3rd and checks in on the 18th. So, if for whatever reason you don’t get into Study A, then you could still get into Study B. Sounds simple, right? Wrong! So let’s assume that you pass the screening for both studies so you check into Study A. You make it in. So when Study B calls to confirm check in, you of course have to decline. While yes, you can withdraw your consent at anytime, a clinic may penalize you on future studies. Some clinics will temporarily ban you from doing studies while others will do nothing. It’s not so bad when you cancel a study before the screening as the clinic hasn’t spent but a few dollars but if you cancel once you have screened, the clinic has spent on average $450 to screen you. This is of course part of running a study but if the clinic has too many qualified people canceling at the last minute, then it eats into the bottom line and of course clinics are businesses (there to make money) so they will make adjustments to their policies to curve the problems. Furthermore, if too many people cancel out of a study and the clinic can’t screen enough people to replace those in time; the study can be postponed or cancelled. So the problems you’re trying to avoid can lead to the same problems for your fellow volunteers.
Okay, so is it bad to have a backup? Yes and no. If you cancel a study for a legitimate reason such as a death in the family, family emergency, then no, that’s life. But if you have a pattern of constantly signing up and canceling studies, then clinics are going to notice and may crack down.

It seems silly that I have to keep writing about this but my thoughts of the week come from my own experiences and those of my close friends. It seems more and more people feel they don’t have to follow simple rules. They feel like the clinics are treating them like children. Why would people feel like this? Because they are required to do stuff during the study? They are required to be at their procedures before the procedure starts? They are required to follow the rules of the clinic? They are required to do things they feel they shouldn’t have to do? Why? Because that is part of the study.

When you sign an informed consent form and house rules form, you are agreeing to follow the rules of the clinic, to complete all of the required procedures and to be on time. Why is time so important? Because the sponsors (drug companies) of the studies are paying millions of dollars to research and develop new medications to help your family and friends to have better pain medications, shorter flu symptoms, an erection when the time is right and treatments for thousands of other ailments.

Studies are conducted to see how the drug affects different people but in order for a study to be conclusive, every subject must complete the study in the same way ie eat the same foods, blood collected at the same times etc. It may not seem like a big deal to you but when a sponsor has to pull a study because the data is useless, it just means that the clinic you are going to will lose a client and that will equate to less studies in the future. It all goes around.

Many of the clinics I go to ban cameras including camera phones yet people still sneak them in and get upset when they are discovered. They argue that they weren’t going to use the camera. Well, if you sneak a gun on a plane but you weren’t going to hijack the plane, does that make it okay? No! Rules are rules! Rules are created in response to problems in the past to prevent problems in the future.

The vast majority of the volunteers DO follow the rules and make the effort to complete their studies properly. It’s just a few bad apples that spoil it for everyone else. So do yourself a favor, realize that doing a study is a serious responsibly and can have serious consequences both seen and unseen for those who choose not to follow the rules.