Stomach cancer clinical trials are important as they are a way of determining whether a drug or therapy is beneficial or not.
New and innovative drugs are often created, but their safety and effectiveness always needs to be determined before it can be used widely.
It is through testing that this is determined and that is why these are so important.
So, what is a clinical trial and how are they organized?
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There are a variety of clinical trials that can be done, but the one with most relevance is the double blind, controlled clinical trial.
It is known as double blind as neither the doctor, nor the person with the condition, knows whether they are getting the treatment or not.
The treatment being investigated is compared to either a recognized therapy to see if it is more effective or to a placebo.
A placebo is an inert drug which looks the same as the medication under investigation, but doesn’t exert any effect on the individual taking it.
In most, new drugs are compared to the most common (and known effective) treatments rather than true placebo. Pure placebo treatments tend to be used in animal studies before human use.
They are always voluntary, but there are few patients these days that are not enrolled in them.
This is testimony to the development of novel therapies for stomach cancer and most people are keen to get involved with this.
Entering a trial after, discussion with your oncologist, will involve consenting to have treatments that may have previously had only limited use in humans.
Most do have exclusion criteria. By this, there is usually an age range and some people may be ineligible because of other health conditions they may have or drugs they are taking.
This all needs discussing with your oncologist.
Stomach cancer clinical trials can be classified in to phase 1, 2, 3, 4 clinical trials are the stages in which a new drug or therapy is checked for benefits and side effects.
Phase 1 involves a very small number of people, usually 15 to 30 people, where the initial effects of the drug are looked at.
If the drug seems to be efficacious, without any serious side effects, a larger sample of people are looked at.
Phase 2 would involve up to 100 people are looked at, testing the safety and benefit in a larger group and the dose of drug that works best.
Phase 3 is undertaken if all goes well and this involves comparing the new drug or treatment against a standard treatment.
It normally involves many more people, hundreds to thousands and if successful, the new treatment can be approved by the governing body (FDA, MHRA, EMA).
Phase 4 occurs after a license has been obtained and these look at the longer term effects of the treatment.
If you would like further information take a look at CenterWatch.
During a trial you will be monitored closely.
At various stages of treatment, measurements will be made to determine the effectiveness of the therapy.
This may be in the form of a questionnaire to determine whether your symptoms have changed, blood samples or scans to determine whether your tumor is responding to your therapy.
If you are having inappropriate side effects or the treatment is ineffective, you may be taken out of the trial and possibly started in a new one.
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