Thoughts from a Lab Rat

It’s been four years since I first learned about clinical research from a homeless man at a library in Kansas City and it’s been a wild ride since. I have long forgotten his name and wish him well for turning me on to this gig. This is the dream job that I never knew existed. I am able to help medical science while enjoying a flexible schedule with a generous four weeks off after each study. And while I’m at each study, the free time has allowed me to create this website to inform the masses about this wonderful opportunity.

I am grateful for the position I am in and truly believe in the cause. Indeed, clinical research has vastly improved the quality of my life. That is why I don’t feel the need to make lots of money through this site. I am happy and content with the way things are in my life both financially as well of self-worth. I have been able to pursue and achieve many of the goals I had before I started. Certainly my most recent goals are grander and more exciting but all attainable with the assistance from clinical research. I encourage all of the long-time volunteers to take a look at what clinical research has done in their lives. This website is my gift to the world. What are you returning to the world?

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.

Radiolabel studies – Pretty much every radiolabel study I have seen pays the subjects based on the length of time spent in the study. In fact, most studies will be structured with a minimum amount of time you can spend and with the longest expected time being used as the basis for payment. Additionally, most radiolabel studies are a single dose. The reason for adding the carbon 14 to the study drug is so it appears better in the blood sample. So let’s say you see a radiolabel study advertised as $4500 for 21 days. In actuality, you will spend a minimum of around 10 to 14 days and will only be paid a daily rate if you don’t spend the entire 21 days in house. The discharge requirements of a radiolabel study usually require the radioactivity level in your urine and fecal samples to drop a certain percentage over a certain period of time after a certain period of time has passed since dosing. So, again, if your results constitute discharge early, you only get paid to that point. So, that is where my beef lies with radiolabel studies. Some people get paid more because it took their body longer to process the drugs than the next person. I feel that everyone in a radiolabel study should be paid the same regardless of how long it takes to excrete. Everyone is taking the same risk, the same amount of drug and the same amount of carbon 14. I would like to see drug companies and clinics change this policy to that the payment is fair to all participants in radiolabel studies.

Clinics can ban volunteers from participating in studies for a variety of reasons. Probably the most common reasons include blood pressure, hot drug/alcohol tests and out-of-range blood labs. Other reasons may include failing to follow the rules of the clinic which can include sneaking in contraband, fighting, vandalism, not calling to cancel screenings and much more. So, if you get banned from a clinic, depending on what you got banned for, you may be able to get the decision reversed.

Drugs and Alcohol - Most clinics have a zero tolerance for positive drug and or alcohol results. If a positive screening comes up, most clinics will send your sample to an outside lab for confirmation. It the outside lab confirms the results, you will probably be banned forever. And forever is a long time!

Blood Pressure, ECG’s, urine and blood - Every study will have an acceptable range for the blood pressure and ECG results. If your results are out of that range, you will be disqualified for that study. If your results are abnormal (more than a little out of range), the study doctor may impose a temporary ban and recommend that you see your own physician and have the tests redone and if they are back in the range that the clinic is looking for, then you may be reinstated. Some exceptions may be made for ECG’s. If the results may indicate irregular heartbeat, heart murmur or other heart conditions, you may be banned permanently as these results may indicate serious heart conditions. It would be recommended that you follow up with your own physician. It is of course possible that the results at the clinic were just abnormal due to stress, nervousness and you are in fact perfectly healthy and your physician will not find any problems. You can try to forward those results to the clinic for reconsideration.

Hepatitis and HIV - Most studies will require these test and if they are positive, you will be banned from the clinic. Positive tests in most cities may also be forward to the health department. If you are informed of a positive result, you should definitely follow up with your own physician.

There are many other reasons that a clinic may ban you and it’s never an issue until it happens. If you are banned, most clinics have a person or department in charge of volunteer relations who can give you information on whether or not you can get reinstated and what information you must provide.

Don’t take everything a clinic tells you as fact. You should always follow up with you own physician. Many people do get banned from clinics but at the same time, they may find out about health conditions they did not know they had and can thus get treatment for it.