A clinical trial is a study that is done in order for researchers to test the use of new drugs or treatment process. Through the opportunity of clinical trials, patients volunteer for special treatments that have yet to have been fully tested or proven 100 percent safe. The primary purpose of the clinical trial is to contribute to the advancement of brain cancer research so that new drugs can be developed, hopefully proving to be more effective than previously used drugs. Patients have the choice to undergo a clinical trial if they have brain cancer and they qualify for the research program. It is often a hard choice to make and patients usually weigh their options and read their situation before making that very tough decision.
to take part in a clinical trial is no easy decision. A patient with brain
cancer would be contributing a great deal if they do take part in the test,
though they may be at risk if the experimental drugs prove to be dangerous or
ineffective. One of three things can happen-- either a drug will be proven to
be not useful, a drug may show signs of success against the brain tumor, or in
very rare cases, a patient may be harmed by the new drug. While tragedies
involving fatal clinical trials are tough to think about, they are important
because they give researchers new information for the overall contribution to
advanced brain tumor treatments. In all likely situations, fatal accidents
would be avoided in the future, using prior data collected. To protect
volunteers of clinical trials, there have been laws and regulations set into
place designed to protect patients and their rights during clinical trials.
A clinical trial attempts to answer two main questions-- does a drug work against fighting brain tumors and is the treatment safe to use?
If a new drug proves to be effective against brain tumors, further follow up questions are asked. Is the treatment more effective than current treatments? If not, is it just as useful as current treatments? If so, does it produce fewer side effects? Does it work in certain people who have not shown positive results in other treatments? If yes is answered to any of these questions, a clinical trial is considered to be successful, moving forward research either a step or a leap, depending on the breakthrough in knowledge.
As far as drug safety is concerned, this is the most important question asked by researchers. Not all brain tumor treatments are 100 percent safe without any risk factors, though researchers attempt to determine if the positive results of a drug outweigh the risks. Remember, the clinical trial is just one step in the development of a new drug. When a possible new drug is discovered, it it is put through many tests in the lab to determine how it reacts to animal cells. More than a thousand drugs are tested in a lab before they are green lit for use in a clinical trial.
There are several misconceptions that one must know before entering into a clinical trial. Every person who is diagnosed with brain cancer or any other type of cancer has a right to choose whether or not he or she would like to participate in the clinical trial. They are all voluntary. Keep in mind that not all of them just study experimental drugs and treatments. Some focus on detection tools and techniques, experimental diagnoses and prevention processes.
Also, some clinical trials focus on drugs that have already been proven to work well. The only difference is that the drugs may be used in combination with other drugs to see how well the two work together to fight the cancer.
In some instances, a placebo may be given. This rarely ever happens, however. They are used to make a patient think that he or she is being treated, but in actuality, he or she was not given a cancer drug. Some researchers have found that when a patient is given a placebo, he or she may claim to feel better. No patients in a clinical trial will only receive a placebo. When this does happen, some patients will receive a combination of treatments and another group will receive one treatment, along with the placebo. They will then compare the results to see if there really is a difference.
First and foremost, a drug that is thought to be effective against cancer will first be tested in a laboratory on living cells, but not on an actual animal. Cancer cells can be grown in the lab and the drug will be administered and the results are observed. This can involve human cells or animal cells. Next, if the initial test proves that the drug seems to have noticeable effect on the cancer cells, subsequent animal testing phase can commence. Treatments that show positive results are then tested on living animals to see what happens to an animal who receives the drug(s) as a treatment. This phase of the clinical trial, while tells a lot, it does not tell the whole story, after all, lab mice and humans are two very different creatures. If the results of the animal trials seem promising, the FDA will give final approval to advance the drug to the actual clinical trial period.
of a Clinical Trial:
Clinical trials are administered in phases, each designed to give researchers new bits of useful information. Brain cancer patients, and other cancer patients will experience the phases outlined below:
During this phase, researchers may only administer a small amount of the new drug or combination of drugs to find out whether or not the drug reaches the tumor to affect it, if at all. Due to the fact that the drug doses are low, the patient is in a low-risk situation, though they will not receive any benefit from taking the drug. During this phase, researchers determine whether or not drugs do as they are expected and if it has any adverse effects to the body.
This phase is the first time a new treatment or a new combination of treatments is given to a person in an attempt to destroy a tumor. This phase is generally given to a small group of people who are in an advanced or untreatable stage of cancer with no other viable options to choose from. The goal of researchers is to determine what the highest dosage of treatment is safe to administer to a patient. This is done by given one group of patients a low dose, watching them closely for side effects and if it is deemed safe, the next group of patients get a higher dose. The safety of the patients are put in high regard during this phase, especially since it is the most unpredictable.
This stage is designed to test the drug's effectiveness and find a better understanding if it is a viable option for fighting the tumor. This stage is considered to be relatively safe because the drug has already been tested numerous times before in phase I studies. Researchers usually observe the patient and tumor to see if it shrinks and improves the overall health of the patient. They will also keep a close eye on the side effects to make sure that they are consistent with other proven drugs and not too severe.
Phase III of clinical trials is an advanced stage where drugs are used on patients that have been already proven to work in shrinking tumors and improving patients' health outlooks. This phase however, is designed as a precautionary stage. They tell researchers how effective and safe the new treatments are compared to already established treatments. Patients are usually chosen at random to receive either a traditional cancer treatment or the new cancer treatment and then compared to each other. Placebos are most often done in the phase III trial.
This advanced clinical trial phase is designed to answer more questions about new treatments. It is designed to determine what kind of long term side effects are possible during the treatment, and is designed to give researchers other information that can only be obtained in the long-term.
Aside from early phases of clinical trials (especially phase 0) there are many benefits that can come from participating in a clinical trial. You will be contributing to the overall progress of cancer research, giving researchers more information than they had before. Also, you will increase the number of treatment options available to you, giving you a better chance of beating cancer and giving you more peace of mind.