Although there are clinical trials for devices as well as other diseases and treatments, drugs for cancer patients are used in the examples of clinical trial phases described here. The purpose of this phase is to help speed up and streamline the drug approval process. This may help save time and money that would have been spent on later phase trials. Phase 0 studies use only a few small doses of a new drug in a few people. They might test whether the drug reaches the tumor, how the drug acts in the human body, and how cancer cells in the human body respond to the drug.
People in these studies might need extra tests such as biopsies, scans, and blood samples as part of the process. The benefit will be for other people in the future. Phase 0 studies are very small, often with fewer than 15 people, and the drug is given only for a short time. Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects.
These studies also help to decide on the best way to give the new treatment. Phase I trials carry the most potential risk. But phase I studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose to join phase I trials when all other treatment options have already been tried. Clinical trials are essential to the development of new medical treatments and diagnostic tests.
Without clinical trials, we cannot properly determine whether new treatments developed in the laboratory or by using animal models are effective or safe or whether a diagnostic test may work properly This is because computer simulation and animal testing can only tell us so much about how a new treatment might work, and are no substitute for testing in a living human body. Clinical trials also allow testing and monitoring of the effect of a treatment on a large number of people to ensure that any improvement as a result of the treatment occurs for many people and is not just a random effect for one person.
The risk may be higher in a clinical trial because there are more unknowns. This is especially true of phase I and II clinical trials , where the treatment has been studied in fewer people. Perhaps a bigger question is if the possible benefits outweigh the risks. People with cancer are often willing to accept a certain amount of risk for a chance to be helped.
Ask your doctor to give you an idea of what the benefits may be and which is likely for you. Some people may decide that any chance of being helped is worth the risk, while others may not. Others may be willing to take certain risks to help others. You will not be a guinea pig, but it's true that the purpose of a clinical trial is to answer a medical question. People who take part in clinical trials may need to do extra things or have certain tests done as part of the clinical trial.
In fact, most people enrolled in clinical trials welcome the extra attention they get from their cancer care team.
Studies have shown that people with cancer who felt well informed before they took part in a clinical trial had less regret after the study than those who felt unsure. A placebo is a fake pill or treatment used in some types of clinical trials to help make sure results are from the new treatment or drug. Most cancer clinical trials do not use placebos unless they are given along with an active drug.
Went along and, you know, a medical, a check-up to see that I was okay to take part in a trial, so I was accepted into the trial, which I believe was a phase 2 trial. It was six months of chemo. It ended up there was a kind of group of us of four or five. In Phase 2 trials we can start to get some idea of whether a treatment works for some people, and what kind of side effects they experience. But at this stage the numbers of people included are still too small to give us firm evidence about its effects and that any observed change is not just happening by chance.
This is why Phase 3 trials are needed. Phase 3, randomised clinical trials Phase 3 trials are usually large, and may include hundreds or even thousands of patients. They often compare the effects of newer drugs or treatments with standard treatments if there are any. They provide a better test of whether new treatments work better than existing treatments, and firmer evidence about how common and serious any side effects are.
Almost all Phase 3 trials are randomised clinical trials RCTs. In an RCT, one group of people, the experimental group, is given the new treatment. The other group, called the control group, is given the standard treatment. If no standard treatment exists, the control group may not be given any specific treatment or may be given a placebo. Some trials may compare more than two groups. A placebo is a treatment, with no active ingredient, which is designed to appear very like the treatment being tested.
There are several ways in which the results of trials can be made as reliable and accurate as possible. In a blind trial the participants are not told which group they are in. This is because if they knew which treatment they were getting it might influence how they felt or reported their symptoms. Some trials are double-blind, which means that neither participants nor the doctors and others treating them know which people are getting which treatments.
Here Wendy describes a typical RCT design comparing standard treatment for bowel cancer with an extra chemotherapy drug. Wendy was asked to take part in a year-long trial of chemotherapy for bowel cancer. She thought Just before Christmas I went to a major hospital away from where we lived, and I had an appointment there to see one of the oncology team.
I also saw a professor, who was leading a trial. So I was then told the, the plan was to have six months of chemotherapy. Alongside that I was offered the chance, if I wanted to, to go into this clinical trial. I asked a few pointed questions. It was all taped, by the way, so we could take the tape away, listen to all the questions, listen to all the things the professor had mentioned. We also had it all in writing as well, so we could read it. She did some research.
We researched it and we had about, I think, two weeks. We went back to see him, at which point he wanted an answer as to whether we were going to go through with it or not.
They explained all the side effects and everything. And after much discussion in the family, thinking about the impact on the children, and if all these side effects did materialise what impact that would have on us as a family with no extended family to call upon, I thought it was too selfish of me to ask for that. They wanted to compare the two. It was a drug that has been used very, very successfully in advanced bowel cancer patients and they now want to trial it to see what the implications are of it on other bowel cancer patients.
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