Thoughts from a Lab Rat

What is a Clinical Research Organization? A Clinical Research Organization also known as Contract Research Organization, supports the Pharmaceutical industry in many ways with the primary objective of conducting clinical research trials. There are thousands of sites across the US. They can be as small as sole practitioner or as large as a hospital. The major clinics that I profile on my site only make up a small percentage of the total sites as the majority of the sites are the small sites that do condition specific trials (patient studies). IE, a weight-loss doctor would only conduct weight-loss studies, a diabetes clinic would only conduct diabetes studies and so on. The major clinics, more commonly known as Phase I clinics conducts studies covering nearly all conditions. In fact, what the medication is for is usually a mute point as Phase I trials gather the pharmacology information rather than to see if the drug actually works for its intended purpose.

Every CRO is slightly different, in the way they manage the trials. It is a competitive industry and CRO’s with marginal results will be passed up for CRO’s with the best track records. What kind of results are the CRO’s trying to get? The most accurate results. This primarily focus on having all the data collected uniformly and accurately. It is widely assumed that the CRO’s decide how to carry out the studies. This is false. The sponsor (drug company) comes to the CRO with their requirements of the study and the CRO conducts the study as requested.

The bottom line is that CRO’s are businesses, not charities. They are here to make money, not give it away. The money they pay you is a stipend for services rendered. Operating a clinic is not as simple as it seems. It takes a large amount of preparation to run a study. It is also very expensive. It costs on average $450 to screen a potential research subject. And that is regardless of whether the subject is accepted into the study. For the CRO’s, it is imperative that the studies are carried out correctly. And you should be equally invested in that goal. If a sponsor gets poor results from a CRO, it will choose a different CRO in the future which in turn will reduce your study opportunities. So be appreciative of the chance you have to not only help medical science but to also earn a little extra change in the process.

It seems that Keebler, a member of Just Another Lab Rat’s forum and the guy behind Lab Rat Crew will be on the Tyra Banks Show. It should air on Friday, May 29th on the CW network I guess he wasn’t actually on the stage? Well, let’s all watch and see what transpired on that cold February day.

I am working on the bi-annual updates to the site but it is taking longer than expect. I am moving to San Antonio as I long for a bigger city life than Austin. So, that’s this weekend so hopefully after I get settled in, I should be able to hammer out the update.

Many studies which have a smoking restriction test for cotinine which is metabolite or by-product of nicotine. Cotinine has a half-life of about 24 hours depending on the amount of cigarettes or cigars smoked. For most people, cotinine can be detected for up to a week after cessation of smoking.

The big concern for healthy subjects who do not smoke should be passive exposure or second-hand smoke. Maybe you live with someone who smokes or you work part-time in a bar where smoking is permitted. By being exposed to second-hand smoke, you are not only putting your health at risk, you are increasing your chances of having a positive cotinine test. Yes, you don’t actually have to smoke cigarettes to test positive! A marginal reading is typically acceptable though depending on the assay method used to test, it may still lead to a disqualification. Levels of 10 ng/mL to 100 ng/mL are generally associated with light smokers and passive exposure or second-hand smoke. Anything higher than 100 ng/mL would be considered an active smoker.

There are two types of second-hand smoke, sidestream and mainstream. Sidestream is the smoke that is emitted from a lit cigarette. Studies have shown that up to 80% of the smoke in the air is from sidestream which makes this type of secondhand smoke more dangerous. Mainstream smoke is the smoke exhaled from the smoker. Exposure to second-hand smoke can thicken the blood by increasing the production of red blood cells. This can lead to clotting and strokes which can lead to heart disease and cancer. Second-hand smoke can also cause increased blood-pressure.

How much second-hand smoke exposure to be harmful is unclear but any prolong periods of exposure is putting you at risk. If you live with a smoker, then you should definitely be concerned. Ask them to smoke outside. I have heard reports of people who live with smokers and have failed a cotinine test. If you are staying in a hotel, make sure you get a non-smoking room. Just because there isn’t someone smoking in front of you doesn’t mean that being in an environment that has been smoked in is any better. I occasionally am exposed to second-hand smoke and I usually end of gagging and covering my mouth with my shirt. Since I rely on studies for my income, I have always been weary of my exposure to second-hand smoke but after doing some further research, I will try to avoid it at all costs.

http://en.wikipedia.org/wiki/Second-hand_smoke

http://health.howstuffworks.com/understanding-secondhand-smoke-ga.htm

Many studies which have a smoking restriction test for cotinine which is metabolite or by-product of nicotine. Cotinine has a half-life of about 24 hours depending on the amount of cigarettes or cigars smoked. For most people, cotinine can be detected for up to a week after cessation of smoking.

The big concern for healthy subjects who do not smoke should be passive exposure or second-hand smoke. Maybe you live with someone who smokes or you work part-time in a bar where smoking is permitted. By being exposed to second-hand smoke, you are not only putting your health at risk, you are increasing your chances of having a positive cotinine test. Yes, you don’t actually have to smoke cigarettes to test positive! A marginal reading is typically acceptable though depending on the assay method used to test, it may still lead to a disqualification. Levels of 10 ng/mL to 100 ng/mL are generally associated with light smokers and passive exposure or second-hand smoke. Anything higher than 100 ng/mL would be considered an active smoker.

There are two types of second-hand smoke, sidestream and mainstream. Sidestream is the smoke that is emitted from a lit cigarette. Studies have shown that up to 80% of the smoke in the air is from sidestream which makes this type of secondhand smoke more dangerous. Mainstream smoke is the smoke exhaled from the smoker. Exposure to second-hand smoke can thicken the blood by increasing the production of red blood cells. This can lead to clotting and strokes which can lead to heart disease and cancer. Second-hand smoke can also cause increased blood-pressure.

How much second-hand smoke exposure to be harmful is unclear but any prolong periods of exposure is putting you at risk. If you live with a smoker, then you should definitely be concerned. Ask them to smoke outside. I have heard reports of people who live with smokers and have failed a cotinine test. If you are staying in a hotel, make sure you get a non-smoking room. Just because there isn’t someone smoking in front of you doesn’t mean that being in an environment that has been smoked in is any better. I occasionally am exposed to second-hand smoke and I usually end of gagging and covering my mouth with my shirt. Since I rely on studies for my income, I have always been weary of my exposure to second-hand smoke but after doing some further research, I will try to avoid it at all costs.

http://en.wikipedia.org/wiki/Second-hand_smoke

http://health.howstuffworks.com/understanding-secondhand-smoke-ga.htm

Many studies require a baseline as part of a study. In simple terms, a baseline is a period of time and collection of records that is compared to another set of time and records which is normally known as the pharmacology line. Okay, it’s probably not called the pharmacology line but it sounds good. The baseline is usually a period of 24 hours but can be shorter or longer. The only difference between the baseline and the pharmacology line is that the baseline is conducted without the study drug and the pharmacology line is with the study drug. All of the procedures during both periods will be done at exactly the same time. The purpose of obtaining a baseline is to compare the normal function of a study subject to the same subject taking the study drug. This allows investigators to see what changes the study drug does to your body. Normally, a baseline is done before the first dose of the study drug. That means that you may check into a study 1 to 2 days or more before the first dose. Normally, backup subjects are kept during the baseline period as subjects can still be disqualified before the first dosing. The pharmacology line period usually begins with the first dose. When doing a study that has a baseline, it is important that both periods are done exactly the same. If some time points in during one period differ from the other, then the results cannot be deemed valid. So if you do a study with a baseline, make sure you are to your procedures early.

Well, you all have probably heard about this flu that is going around and the fatal effects it can have. As a precaution, if you have travelled to Mexico within the last 2 weeks or you have been experiencing the flu or flu-like symptoms, then it is highly recommended that you do not attempt to screen or check-in to a study. The consequences of exposing a large number of study volunteers and clinic staff to this potentially fatal virus can be devastating and irresponsible. While earning some extra cash by participating in a research study is great, killing a bunch of people is not. Okay, that sounded really bad but it is true. I have that worst case scenario mentality. Hopefully this threat will subside in the near future and it will be a distant memory but for now, take extra precautions to protect yourself. Simple things like washing your hands and avoiding crowded and cramped conditions.

Major updates coming the middle of May. I am getting ready to do my bi-annual update and verification of my site. While I do update clinic pages as new or changed information comes in, I check all of the travel information twice a year. I am working on some other ideas but am not sure when I will implement them. I am seeing how twitter works and have been told this could be a simple yet effective tool.

One of the most common problems people get disqualified for seems to be ‘out of range’ blood pressure. More than likely, it’s just nervousness and or anxiety. For many people, getting into a study means the difference between paying your rent and living on the streets. It shouldn’t be that way. But it’s stress like that than can cause your blood pressure to go up. Most of the time it is a psychological problem. If you stare at the machine or the clock or the technician and your waiting for the test to start, then your body is going to tense up. Try just staring at a fixed object. Let your body relax. Don’t anticipate the test starting. Think about something you like to do or something relaxing. Sounds retarded but it works for me most of the time. When I screen and check-in to a study, my blood pressure us usually in the upper limits but once I’m in the study, my blood pressure returns to normal. Again, it’s mostly psycological. Just don’t think about it. Some other minor factors include wearing tight clothes, tight shoes, the cuff is too tight or too small and talking. You should not talk or laugh during the test. Lastly, try to breathe as normally as possible. Don’t try to regulate your breathing because your just using more energy which can drive up your bp.

How to remove a camera from a laptop (New!)

How to avoid scams on the internet (New!)