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.

Repeats are routine but what are they and how do they work? Well, a repeat is called by the study doctor when a lab value, ECG, blood-pressure or other screening factor is outside of the protocol range. Each study has a range that every lab result must be within. Depending on how out of range the result is will determine whether a repeat will be allowed. Typically, things like blood pressure, body temperature and pulse rate will have an automatic repeat and depending on the study, may allow a manual repeat by a paramedic. Values related to drugs, cotinine and alcohol are not repeated and typically will result in automatic disqualification. For street drugs and sometimes alcohol, you may be banned from the clinic permanently. For most urine and blood values, if your results are slightly out of range, you will typically be called in for a repeat. If the study doctor feels that your results are “clinically significant” or abnormally out of range, you may not get a repeat and will be disqualified from the study. Sometimes the study doctor will refer you to your own physician for a follow-up before you are allowed to screen again.
A repeat can happen at any stage of the study. You can have a repeat from your screening, check-in, anytime during the study, your exit labs and or any outpatient visits. It is important to note that if you have a repeat for your screening, you are not considered screened until you complete the repeat. If you are finishing a study and have a repeat, you are not considered finished with the study until you complete the repeat. Any delays in doing a repeat can affect your inclusion into a study and your payment after a study. If you are asked for a repeat, you should try to get it done as fast as possible.
The reason repeats are done is to ensure your safety before, during and after a study. The study doctor wants to make sure that your screening labs are all within normal or sponsor required ranges to see if there are any changes once you start dosing in the study. Comparisons are done throughout the study to detect any problems. It’s best to think of repeats as being “better safe than sorry”.

It happens a lot. Even I get disqualified occasionally. But a good 20% of disqualifications are for out-of-range blood pressure. Every study has certain ranges that everything must fall into. The blood pressure ranges are usually 90/50 to 140/90. The first number is systolic and the second number is diastolic. The pulse is usually 40 to 50 over 90. For a detailed explanation of blood pressure, click here for the wikipedia entry. Certain studies may have lower or higher cut-offs depending on the sponsor requirements.

There is a lot of talk about the machines that some clinics use, being poorly calibrated because the only time they have out-of-range blood pressure is when they use that machine. While it is true that machine measurement is not the most accurate method, it is considered clinically reliable, hence why they are used. However, most people who get disqualified are are only a few points over or under which is not clinically significant. I have a problem with getting stressed out. I mean hey, I trying to get into a study so my stress level is high. Once I get into a study and my mind knows this, my blood pressure is normal, middle range. It’s only at screenings and check-in.

There are a few tips to help improve your blood pressure. First of all, make sure you use your bare arm. Sleeves can give abnormal results. Breath deeply. Don’t look at the machine or the clock. If your body knows when it’s going to run, it’s going to tense. Keep your feet flat on the floor. Wear loose fitting clothes. Don’t wear anything that will constrict your waist. Rest the arm that you use as high as possible. The lower your arm is from your heart, the harder it has to pump to circulate blood. Don’t think about it. That’s kinda hard, but think about something else. If you have to get a repeat, breathe deeper and don’t stress out.

If you are disqualified for out-of-range blood pressure, unless it was very high, you can still screen for another study at a later date. Occasionally, they may suggest that you see your physician to follow up. While it is unfortunate to get disqualified, there is not much you can do. Sometimes your body is stressed out, sometimes you get a bad reading. But once the clinic runs the tests, the results are final. Just relax and don’t panic.

In almost every study, you will have at least one day of heavy blood draws more commonly known as PK day, kinetics or pharmakinetics. Depending on the study, you may have one or more of these days. Your blood will be drawn from six or seven to fifteen or more times. Unless otherwise specified, these will be straight sticks or a fresh needle each time. In the event the phlebotomist can’t get enough blood on the first try, someone else will try again with a new needle. Some studies will allow a heplock or also known as a heparin cannula. This is a plastic tube that is inserted into your vein and operates like a spigot. Each time it is used, it must be flushed with heparin, thus many sponsors do not allow heplocks.

It is highly recommended that subjects have at least 2 good veins on each arm which should minimize difficulties in drawing blood. In order to assure that you have minimal problems, you should drink a consistent amount of water everyday, in a study and during your normal life. Two liters a day is recommended for most people. On the day before, during and after a kinetic day, you should increase your water intake by sixteen to thirty two ounces. After a blood draw, hold your arm straight and the gauze with firm pressure for at least ten minutes. Just because it stops bleeding on the outside doesn’t mean it has stopped on the inside. This will reduce the chance of scar tissue. If your blood draw site becomes swollen, you should ice it and switch to a different vein or the other arm. Do not get your blood drawn after the vein has been iced. It can be painful and the vein will be constricted. If your veins have trouble popping to the surface, consider a squeeze ball or stress reliever. Once the blood gets flowing into the tube, relax your fist. On a final note, once your study is complete, use vitamin E oil or lotion to help heal the scarring. Cocoa butter lotion is also good.

Well, it’s been quite a rough year so far. Just not having a lot of luck as far as getting into studies is concerned. Just little things getting out of whack like too much potassium (strange as I don’t eat bananas) or my blood pressure is too high. Unfortunately, that is part of the game. You will have times when you don’t get into studies and it always seems to be at a time when you want the money the most. If you are excluded from a study for a laboratory result, it doesn’t necessarily mean you are unhealthy. It just means that your results were out of the range the sponsor was looking for. Your lab values change from day to day and I’ve said it a millions times that it’s amazing that all the things they check for are ever all within range at one time. You just gotta make sure you eat healthy, don’t do any heavy exercise and keep trying. And by way, a lot of people like me, get nervous and overexcited during vitals. So your results are artificially high. As soon as I dose and know I’m in the study, my BP is rock solid in the mid range. So, a few tips, don’t look at the machine or the clock, keep your feet flat on the ground, wear loose clothes, breathe deeply and just relax. Your friend in time, Paul