Clinical trials are an important component in the development of new drugs and medical interventions. They provide a mechanism through which the effectiveness and safety profile of new forms of therapy are tested before being adopted as routine practice. There are a number of facts on clinical trials Brandon Fl aspiring researchers need to know.
This process of testing is usually preceded by what is termed preclinical research. At this stage the new molecules or methods of intervention are tested on animal models, human cells or tissues in a laboratory. This step determines whether the trial will proceed or will be abandoned. For instance, if a new drug is found to be toxic to animal models, there is a very high likelihood that it will be harmful to human tissues as well hence, there is no need to proceed.
The clinical research proper starts with phase zero. This is the first point at which a drug is given to human subjects. The number of people is usually small (about 15) and the dose of the drug is also quite low. This is to avoid unwanted effects that may not be known yet. It takes a few months to complete.
The next stage is phase one. This is only carried out if phase zero was successful. If the findings were unfavourable the options include making changes on the molecule or abandoning the study. This phase requires several months to be completed. It involves a slightly higher number of people who range from twenty to eighty. The main aim of this stage is to study the safety profile of the drug.
Phase one is also important in several other respects other than side effect profiling. For instance, it is the period during which the effective dosage is determined. This is done by gradually increasing the amount administered to subjects and monitoring the side effects. The optimal dose is the highest that can be given without resulting in serious side effects. The route of administration can also be determined at this time.
Roughly three quarters of phase one studies move to the next stage. The number of participants is increased to hundreds in phase 2. It is a requirement that all the participants have the condition or illness that is being treated by the drug. This helps in assessing drug effectiveness. Several months of follow up are needed so as to collect enough data.
By the time the trial gets to phase 3, the number of participants usually has expanded to several thousands. This group also comprises persons that are suffering from the disease. The main aim of this phase is to look at the strengths and weaknesses of a new drug as compared to those that have been in use in the treatment of a particular illness. The new drug should be safer and preferably more effective to get approval .
The final phase, 4, takes place after a drug has been approved for human use. About a quarter to a third of studies from the third stage, make it to the fourth. Thousands of participants in a vast geographical area are involved. The idea is to monitor long term side effects of the drug since these may not be evident in the earlier stages.
This process of testing is usually preceded by what is termed preclinical research. At this stage the new molecules or methods of intervention are tested on animal models, human cells or tissues in a laboratory. This step determines whether the trial will proceed or will be abandoned. For instance, if a new drug is found to be toxic to animal models, there is a very high likelihood that it will be harmful to human tissues as well hence, there is no need to proceed.
The clinical research proper starts with phase zero. This is the first point at which a drug is given to human subjects. The number of people is usually small (about 15) and the dose of the drug is also quite low. This is to avoid unwanted effects that may not be known yet. It takes a few months to complete.
The next stage is phase one. This is only carried out if phase zero was successful. If the findings were unfavourable the options include making changes on the molecule or abandoning the study. This phase requires several months to be completed. It involves a slightly higher number of people who range from twenty to eighty. The main aim of this stage is to study the safety profile of the drug.
Phase one is also important in several other respects other than side effect profiling. For instance, it is the period during which the effective dosage is determined. This is done by gradually increasing the amount administered to subjects and monitoring the side effects. The optimal dose is the highest that can be given without resulting in serious side effects. The route of administration can also be determined at this time.
Roughly three quarters of phase one studies move to the next stage. The number of participants is increased to hundreds in phase 2. It is a requirement that all the participants have the condition or illness that is being treated by the drug. This helps in assessing drug effectiveness. Several months of follow up are needed so as to collect enough data.
By the time the trial gets to phase 3, the number of participants usually has expanded to several thousands. This group also comprises persons that are suffering from the disease. The main aim of this phase is to look at the strengths and weaknesses of a new drug as compared to those that have been in use in the treatment of a particular illness. The new drug should be safer and preferably more effective to get approval .
The final phase, 4, takes place after a drug has been approved for human use. About a quarter to a third of studies from the third stage, make it to the fourth. Thousands of participants in a vast geographical area are involved. The idea is to monitor long term side effects of the drug since these may not be evident in the earlier stages.
About the Author:
Learn more about the clinical trials Brandon FL locals are talking about by visiting our official website now. To know more about our future treatments and our cause, click the links at http://www.clinicalresearchofbrandon.com today.
