Have you ever wondered who discovered Viagra and how many years of research it took for it to come out on the market? Have you ever thought about the number of voluntary patients who sell their bodies to clinical trials in the name of science? Well, the number is staggering, mainly because of the large paycheck that comes with the job.
how does it work?
Although drugs go through various testing procedures, there are generally four stages involved in bringing a new drug from the drawing board to the general public.
Research and development
Hundreds of researchers in different fields of biological and chemical studies work together to identify existing or potential diseases, and formulate thousands of variations on the chemical structure of a drug in order to find the perfect one for each disease.
Preclinical trials
Pharmaceutical companies investigate the safety of about 0.002% of the potential drug variations in a controlled laboratory environment -- that is, on animals. Usually, the animals are "destroyed" after the completion of each trial. The type of animals include -- but are not restricted to -- mice, rats, rabbits, dogs, and chimps.
Phase I - III clinical trials
The next step is a study designed to assess the benefits and side effects of certain drug compounds on approximately 30 to 100 human subjects. It is the first evaluation of a new drug in humans.
In addition to assessing its safety and tolerance, the researchers gain information about its side effects. As they do so, they also select an optimum dose range for the new drug. Finally, comparative testing is performed with conventional marketed therapies if any exist.
Phase IV - Post-marketing evaluation
This stage is designed to identify rare or infrequent side effects once the drug has been approved by the FDA for use by the general public. Researchers also evaluate the pharmacoeconomics and quality of life attributed to the new drug.
the good and the bad
As a university student, I used to hear a lot of chatter about easy ways to make a lot of cash quickly.
A friend of mine told me about a Contract Research Organization (which will remain anonymous) that was recruiting healthy, non-smoking males between the ages of 18 and 45 for a two-weekend stay at their clinical site. And the best part of the deal was that they paid $2,000. Who could say no? Well, I did.
Shortly after, another buddy of mine told me how badly he was treated. They literally made him feel like a guinea pig. His meals, sleep and playtime were strictly controlled, and he had no privacy whatsoever. However, after I went into the field of clinical research myself, I realized the importance and benefits of enrolling in these trials, and I also found out that my buddy was exaggerating.
benefits
There are many benefits to participating in clinical trials:
• They allow affected patients to be exposed to new and innovative therapies that wouldn't normally be available to them.
• They help ensure the safety and effectiveness of new medicines, devices and medical therapies.
• You can make a lot of money; a two- to three-day clinical trial will generally pay between $1,000 and $2,000.
side effects
Although there are clearly more pros than cons in this matter, the major downside of participating in these trials is the potential serious damage to your health.
For example, I remember a study in which 70 cancer patients were enrolled in a Phase I trial for a new drug that was used in conjunction with lasers to destroy cancerous cells.
The drug was supposed to sensitize skin cells in order to help the laser to do its job. However, an unfortunate event occurred: The effect of the drug never wore off, and the patients still experience first- and second-degree burns on their skin when exposed to regular daylight.
your life, your choice
A word of caution for those interested in participating in a clinical trial: Read the fine print of the Informed Consent Form.
Nothing is hidden from the patient. This form basically explains what they will do to you during the trial and what the possible side effects of the drug are. Of course, there is always a risk involved, but you should generally be safe, as pharmaceutical companies follow a strict ethical code of conduct when running these trials.
A brand new drug therapy holds more risk than one that has already been tested and is out on the market -- yes, they still perform trials on already marketed drugs. So choose carefully and wisely.
I highly recommend that people who suffer from a yet non-curable disease try new therapies. Not only do you have nothing to lose, but you will also be helping to get the drug onto the market where others might also benefit from it.
how does it work?
Although drugs go through various testing procedures, there are generally four stages involved in bringing a new drug from the drawing board to the general public.
Research and development
Hundreds of researchers in different fields of biological and chemical studies work together to identify existing or potential diseases, and formulate thousands of variations on the chemical structure of a drug in order to find the perfect one for each disease.
Preclinical trials
Pharmaceutical companies investigate the safety of about 0.002% of the potential drug variations in a controlled laboratory environment -- that is, on animals. Usually, the animals are "destroyed" after the completion of each trial. The type of animals include -- but are not restricted to -- mice, rats, rabbits, dogs, and chimps.
Phase I - III clinical trials
The next step is a study designed to assess the benefits and side effects of certain drug compounds on approximately 30 to 100 human subjects. It is the first evaluation of a new drug in humans.
In addition to assessing its safety and tolerance, the researchers gain information about its side effects. As they do so, they also select an optimum dose range for the new drug. Finally, comparative testing is performed with conventional marketed therapies if any exist.
Phase IV - Post-marketing evaluation
This stage is designed to identify rare or infrequent side effects once the drug has been approved by the FDA for use by the general public. Researchers also evaluate the pharmacoeconomics and quality of life attributed to the new drug.
the good and the bad
As a university student, I used to hear a lot of chatter about easy ways to make a lot of cash quickly.
A friend of mine told me about a Contract Research Organization (which will remain anonymous) that was recruiting healthy, non-smoking males between the ages of 18 and 45 for a two-weekend stay at their clinical site. And the best part of the deal was that they paid $2,000. Who could say no? Well, I did.
Shortly after, another buddy of mine told me how badly he was treated. They literally made him feel like a guinea pig. His meals, sleep and playtime were strictly controlled, and he had no privacy whatsoever. However, after I went into the field of clinical research myself, I realized the importance and benefits of enrolling in these trials, and I also found out that my buddy was exaggerating.
benefits
There are many benefits to participating in clinical trials:
• They allow affected patients to be exposed to new and innovative therapies that wouldn't normally be available to them.
• They help ensure the safety and effectiveness of new medicines, devices and medical therapies.
• You can make a lot of money; a two- to three-day clinical trial will generally pay between $1,000 and $2,000.
side effects
Although there are clearly more pros than cons in this matter, the major downside of participating in these trials is the potential serious damage to your health.
For example, I remember a study in which 70 cancer patients were enrolled in a Phase I trial for a new drug that was used in conjunction with lasers to destroy cancerous cells.
The drug was supposed to sensitize skin cells in order to help the laser to do its job. However, an unfortunate event occurred: The effect of the drug never wore off, and the patients still experience first- and second-degree burns on their skin when exposed to regular daylight.
your life, your choice
A word of caution for those interested in participating in a clinical trial: Read the fine print of the Informed Consent Form.
Nothing is hidden from the patient. This form basically explains what they will do to you during the trial and what the possible side effects of the drug are. Of course, there is always a risk involved, but you should generally be safe, as pharmaceutical companies follow a strict ethical code of conduct when running these trials.
A brand new drug therapy holds more risk than one that has already been tested and is out on the market -- yes, they still perform trials on already marketed drugs. So choose carefully and wisely.
I highly recommend that people who suffer from a yet non-curable disease try new therapies. Not only do you have nothing to lose, but you will also be helping to get the drug onto the market where others might also benefit from it.
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