Clinical Trial Paper
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- Category: Science
- Date Submitted: 04/17/2010 09:24 AM
- Pages: 16
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The Purpose of Clinical Research
When a pharmaceutical company wants to bring a new drug to market, they need proof that the drug is safe and effective. It's important to realize, however, that no drug is absolutely safe. There is always a risk of an adverse reaction. The FDA uses a cost benefit analysis to determine if the drug can be released to the public. When the FDA determines that the benefits outweigh the risks they consider the drug safe enough to approve. The purpose of clinical research is to determine the safety and efficacy of the Investigational New Drug (IND) for the treatment of a particular disease or condition in humans.
Clinical research is divided into three phases in the normal course of testing. The first phase is the Pre-Clinical Research Stage. During this stage, the drug is synthesized and purified. Tests are performed on animals and the institutional review board assesses the studies to make recommendations about how to proceed. If recommendations are positive, then an application is submitted to the FDA and clinical tests begin.
Following the Pre-Clinical Research Stage are three phases of clinical studies and trials. These studies look at how the drug effects human volunteer patients. Next a larger clinical trial is conducted on a larger human population for the purpose of learning about short-term side effects or risks. Finally, the phase 3 clinical trials provide more informaiton about the safety of the drug and look at the effects on a larger population with which scientists extrapolate the results to the general population.
There are several checks and balances in the process of clinical trials; among them is the use of institutional review boards (IRBs) and advisory committees. IRBs are designed to protect the rights and welfare of people participating in clinical trials both before and during the trials. IRB's are made up of a group of at least five experts and lay people with diverse backgrounds to provide a complete...
When a pharmaceutical company wants to bring a new drug to market, they need proof that the drug is safe and effective. It's important to realize, however, that no drug is absolutely safe. There is always a risk of an adverse reaction. The FDA uses a cost benefit analysis to determine if the drug can be released to the public. When the FDA determines that the benefits outweigh the risks they consider the drug safe enough to approve. The purpose of clinical research is to determine the safety and efficacy of the Investigational New Drug (IND) for the treatment of a particular disease or condition in humans.
Clinical research is divided into three phases in the normal course of testing. The first phase is the Pre-Clinical Research Stage. During this stage, the drug is synthesized and purified. Tests are performed on animals and the institutional review board assesses the studies to make recommendations about how to proceed. If recommendations are positive, then an application is submitted to the FDA and clinical tests begin.
Following the Pre-Clinical Research Stage are three phases of clinical studies and trials. These studies look at how the drug effects human volunteer patients. Next a larger clinical trial is conducted on a larger human population for the purpose of learning about short-term side effects or risks. Finally, the phase 3 clinical trials provide more informaiton about the safety of the drug and look at the effects on a larger population with which scientists extrapolate the results to the general population.
There are several checks and balances in the process of clinical trials; among them is the use of institutional review boards (IRBs) and advisory committees. IRBs are designed to protect the rights and welfare of people participating in clinical trials both before and during the trials. IRB's are made up of a group of at least five experts and lay people with diverse backgrounds to provide a complete...