Participation in Clinical Trials
Bringing a new drug to market is a time-consuming task for a pharmaceutical company as it takes many years from the moment it is found in the laboratory to when it can be found in pharmacies.
In order to get it to market however, pharmaceutical companies need your help.
They need to make sure that: 1.
The drug works as they intend 2.
The drug is better than other drugs that treat the same disease or condition 3.
The drug is safe In order to do this, pharmaceutical companies need patients to enroll in their clinical trials.
People enroll in Clinical Trials for a variety of reasons.
It can be to gain access to novel therapies that aren't yet commercially available, or it can be to help further the knowledge of science, or to gain additional information about the disease in question.
Regardless, the decision to enroll in a biomedical research study is a very personal one and you should feel pressured into joining.
A clinical trial is designed to allow researchers to identify whether the designed therapy is working and in certain cases, what is the best method of drug administration such as injection, capsules, nasal spray etc.
The overall design of the clinical trial is known as the protocol and within the protocol you can find a variety of information such as: - Why the Clinical Trial is being conducted - What are the eligibility criteria for participation - What are the ineligibility criteria for participation - What data will be captured about each subject - How many subjects are they looking for - How long will it last If your doctor asks about your participation in a Clinical Trial, make sure to ask about the protocol as well as the risks associated with the trial.
It is always a good idea to discuss a trial with your primary care doctor as they will be more familiar with your condition than the researchers.
If you do decide to participate, it will probably not be with your primary care physician but one who is acting as an 'investigator' in the trial.
When you meet with the investigator, they will go through the protocol and should explain to you: - What the Clinical Trial is trying to show - The risks involved - The criteria to be admitted to the study (such as Age, Gender, Race, Stage of disease etc.
) - The criteria that would exclude you from the study (such as additional medications taken, prior treatments undergone, additional medical conditions you may have etc.
) - How you would be treated - What data on you will be captured - Any other questions you may have The above is known as 'informed consent' and without this, the investigator cannot admit you into the Clinical study.
In order to get it to market however, pharmaceutical companies need your help.
They need to make sure that: 1.
The drug works as they intend 2.
The drug is better than other drugs that treat the same disease or condition 3.
The drug is safe In order to do this, pharmaceutical companies need patients to enroll in their clinical trials.
People enroll in Clinical Trials for a variety of reasons.
It can be to gain access to novel therapies that aren't yet commercially available, or it can be to help further the knowledge of science, or to gain additional information about the disease in question.
Regardless, the decision to enroll in a biomedical research study is a very personal one and you should feel pressured into joining.
A clinical trial is designed to allow researchers to identify whether the designed therapy is working and in certain cases, what is the best method of drug administration such as injection, capsules, nasal spray etc.
The overall design of the clinical trial is known as the protocol and within the protocol you can find a variety of information such as: - Why the Clinical Trial is being conducted - What are the eligibility criteria for participation - What are the ineligibility criteria for participation - What data will be captured about each subject - How many subjects are they looking for - How long will it last If your doctor asks about your participation in a Clinical Trial, make sure to ask about the protocol as well as the risks associated with the trial.
It is always a good idea to discuss a trial with your primary care doctor as they will be more familiar with your condition than the researchers.
If you do decide to participate, it will probably not be with your primary care physician but one who is acting as an 'investigator' in the trial.
When you meet with the investigator, they will go through the protocol and should explain to you: - What the Clinical Trial is trying to show - The risks involved - The criteria to be admitted to the study (such as Age, Gender, Race, Stage of disease etc.
) - The criteria that would exclude you from the study (such as additional medications taken, prior treatments undergone, additional medical conditions you may have etc.
) - How you would be treated - What data on you will be captured - Any other questions you may have The above is known as 'informed consent' and without this, the investigator cannot admit you into the Clinical study.
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