Thoughts from a Lab Rat

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”.

The sponsor is the company that is sponsoring the study. In most cases, the company is a pharmaceutical company. When you participate in a research study, you will take drugs from major companies you’ve heard of and from smaller companies all over the world that you never knew existed. Companies like Bristol-Myers Squibb, GlaxoSmithKline, Merck & Co., Pfizer, Sanofi-Aventis and Schering-Plough all use clinics to test their drugs. There are hundreds of other companies you will see as well. Take a look at the wikipedia entries for the above companies and chances are that you may have done a study involving one of their drugs most likely as a reference product or complying drug. When a clinic conducts a study for a sponsor, there will usually be representatives for the sponsor present for the first does of a study and various points throughout the study. You will occasionally see clinic executives giving tours of the facilities while your in-house to potential sponsors. There is typically no interaction between the sponsors and the volunteer research subjects. The sponsor reps are merely there to see that the study is being carried out according to protocol. While you should always be following the rules of the study and the clinic, it is especially important to do so while sponsors are around as THEY are the ones paying you! If they see that the subjects are not following the protocol of the study, they can stop the study and move it to another research clinic in which case the clinic lose business and in turn reduces the amount of studies available to you. So, to wrap things up, the sponsor is the invisible force behind the study and you should respect the sponsor as they not only pay you but are trying to get new drugs into the market place for benefit of countless people in need.

Too often when I’m in the clinics I hear people say that there aren’t any studies available. Well, as the webmaster of this website, I have to disagree. The real problem is that the studies available don’t suit their interests. That’s fine. To each their own.

But let’s not forget what clinical research is all about. We Lab Rats test all drugs that are available to the consumers. Unfortunately, not every drug requires a 52 night, $10,500 study to make it to the market. But every drug is important to someone. Whether it’s the people who need to treat their diabetes to the people trying to get over their cold 24 hours quicker to the people looking for treatments to their cancers. Every drug that makes it to market requires dozens of clinical research studies. Even the many drugs that never make it to market benefit from the few studies conducted as better formulations lead to better drugs.

The beauty of clinic research is that there are so many different types and lengths of studies available to suit the interests of all walks of life.

Together, all Lab Rats make a difference!

I have heard many people talk about how they are ashamed of doing clinical research studies for money. Nothing more than whoring for money. Well, the fact is that new drugs cannot make it to the market unless they are tested rigorously on humans first. There should be nothing to be ashamed of. You are helping drugs get through the pipeline so people with ailments and diseases can live a better life. If anything, you are a hero. A silent hero who nobody knows but a hero nonetheless. Without research subjects, there would be no new drugs. So be proud of what you do! Tell your friends, parents and anyone else you meet that your Just Another Lab Rat! Well, you don’t have to say that, but that you participate in medical research studies which tests new medications. Or that you work in a lab. And their like, so you’re some kind of scientist?