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.
Any trial is usually preceded by a feasibility study. The drug under development has to undergo several stages of laboratory tests before it can be used in human subjects. This is what is known as preclinical research. The idea here is to determine the effect of the molecule in question on human cells or animal models.
The next step is done in several phases, zero to four. Phase zero marks the start of testing in humans. A small number of people are recruited to take place in the study and are only given a small dose of the drug being tested. This helps avoid serious side effects which may not be known yet.
If a drug shows serious side effects, the next phase cannot take off. The researcher has the option of modifying the molecule or giving up the study at this stage. Phase one is slightly larger than phase zero. The number of persons that are required at this point should be anywhere between 20 and 80. This stage is conducted over a couple of months with the main emphasis being on how safe the drug in question is.
Apart from looking at the safety profile, phase 1 is also critical in determining the optimal dosage of a drug. A gradual increase in the dosage is done over time with the aim of establishing the highest possible dose that is not associated with serious side effects. Information relating to the best mode of administration is also obtained during this phase.
About three quarters of phase one trials proceed to phase 2.The number of subjects is in the hundreds at this point. The usually have the disease or medical condition for which the drug is being developed. Participants will usually be followed up over several months to a few years. Data from this phase are used to determine how the next phase is to be carried out.
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, four, is conducted after approval of the drug. Just a quarter of phase 3 trials get to this point, on average. The role of this stage is to conduct surveillance with the aim of documenting long term and rare side effects. Many years are required for the completion of this stage.
Any trial is usually preceded by a feasibility study. The drug under development has to undergo several stages of laboratory tests before it can be used in human subjects. This is what is known as preclinical research. The idea here is to determine the effect of the molecule in question on human cells or animal models.
The next step is done in several phases, zero to four. Phase zero marks the start of testing in humans. A small number of people are recruited to take place in the study and are only given a small dose of the drug being tested. This helps avoid serious side effects which may not be known yet.
If a drug shows serious side effects, the next phase cannot take off. The researcher has the option of modifying the molecule or giving up the study at this stage. Phase one is slightly larger than phase zero. The number of persons that are required at this point should be anywhere between 20 and 80. This stage is conducted over a couple of months with the main emphasis being on how safe the drug in question is.
Apart from looking at the safety profile, phase 1 is also critical in determining the optimal dosage of a drug. A gradual increase in the dosage is done over time with the aim of establishing the highest possible dose that is not associated with serious side effects. Information relating to the best mode of administration is also obtained during this phase.
About three quarters of phase one trials proceed to phase 2.The number of subjects is in the hundreds at this point. The usually have the disease or medical condition for which the drug is being developed. Participants will usually be followed up over several months to a few years. Data from this phase are used to determine how the next phase is to be carried out.
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, four, is conducted after approval of the drug. Just a quarter of phase 3 trials get to this point, on average. The role of this stage is to conduct surveillance with the aim of documenting long term and rare side effects. Many years are required for the completion of this stage.
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