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Archive for the 'Clinical Trials' Category
It’s important to get the phone number of a doctor or nurse who’s working with the trial who you can call at any time of the night or day, in case of emergency. If you get sick in the middle of the night, doctors in an emergency room may not know what to do, because the treatments in trials are experimental.
Joining a trial is not the same as getting a new doctor. Although your health will be watched at the trial site (where the trial is carried out), clinical trials are not meant to give you comprehensive health care (complete). It’s important that you have your own physician, who knows your complete medical history, in case of an emergency. You’ll need a complete examination before you join the trial, as well as your usual check-ups and lab tests while you’re in it.
You may have to have some of the same tests done for the trial; your doctor and the people at the site can work out a way to share results so you only have to do a test once. And your doctor or you go to the clinic can help you decide whether or not to join the trial
Your doctor can refer you to a trial. But you may have to find out on your own about what trials are taking place. If you find a trial that interests you, the first step is to call a trial site (one of the places doing the trial), which is usually at a hospital. The staff at the site will ask questions over the phone to find out whether you would be eligible for the trial. If you’re still interested, you can arrange to visit the site for an interview. You may want to talk to someone who’s in the trial to get more information before you go.
During the interview, you’ll be asked detailed questions about your health, medical history, and any medication you’re currently using. (You may want to bring your notes or medical diary.) A medical exam and some lab tests will be done. Sometimes you may be asked to come back for a second interview.
Every trial has strict rules about who can join, called inclusion and exclusion criteria. Inclusion criteria are what you need to have or be in order to join the trial. For example, you may need to have a T4 cell count within a certain range, or be above or below a certain age. Exclusion criteria are things that will keep you out of the trial - for instance, you can not have certain illnesses or take certain treatments while in the trial.
If a particular condition is to be treated or prevented, the inclusion criteria are meant to bring in people who have or are likely to get that condition. The exclusion criteria are intended to keep out people who are at greatest risk of harm from the experimental treatment. In practice, the inclusion and exclusion criteria have sometimes been used unfairly to prevent people from participating in a clinical trial.
Pregnant women and drug users are often kept out of trials. Women may have to use birth control because the effects of an experimental treatment on a fetus are unknown, or are suspected to be harmful. Drug companies are unwilling to take the risk of being sued and therefore try to keep out women who do not use birth control. It’s important that women be included in clinical trials, because women’s bodies are different from men’s and may require different doses and types of treatment. More research is needed on treatments for diseases like cervical dysplasia and cancer, which are more common and harder to treat in HIV-positive women.
The relationships between HIV and cervical cancer, and HIV and PID, also need further research. In general, not enough is known about how AIDS develops in women and in children.
Drug users are often kept out of trials because it’s hard for researchers to know what they’re taking (since most street drugs are not pure). They may also be seen as unreliable and in poor health. However, more information is needed on drug use and HIV.
In ideal circumstances, the reason to join a clinical trial would be to help yourself and other people with HIV / AIDS find out whether a new treatment works. However, for some people, joining a clinical trial may be the only way to get free access to a treatment or diagnostic test. Although clinical trials provide access to new treatments and provide medication free of charge, you should be careful not to treat the trial as a form of care. Trials are scientific experiments and, can not replace the care you receive from your physician.
If you join a clinical trial to get a new treatment, you should check with trial organizers to make sure you’re in the group receiving that treatment. If they can not guarantee that you will receive the treatment, you can ask to join the compassionate arm of the trial, if there is one.
Placebos are still used in some Phase 2 and 3 trials. When the first AIDS-related clinical trials were done, some people received placebos and nothing else. But now that AZT, ddI, ddC and have been approved to fight HIV, this is no longer done in tests of anti-HIV treatments. If you join a trial using a new treatment to fight HIV, you should get either an approved treatment or the new treatment. But the trial may still use a placebo in this way:
One group would get the new treatment plus AZT, ddI, ddC or.
For some of the illnesses that people with AIDS can get, there are no approved treatments. In trials for treatments for these illnesses, a placebo may be used alone. However, the use of placebos is becoming rare.
A placebo used in a trial has to look - and be given - exactly like the treatment being tested. So if the treatment is injected into your vein for two hours, the placebo will be injected into your vein for two hours.
Many AIDS activists have questioned the use of placebos in clinical trials. They believe that it is wrong for a person to have to give up other treatments in order to participate in a trial and possibly receive no treatment for an existing infection, or to be exposed to infections that might otherwise have been prevented. This is why AIDS activists fight to have treatments in clinical trials available through compassionate access.
One group, called the study group, takes the new treatment (sometimes this group will take the new treatment in combination with the approved treatment taken by the second group). There may also be a number of study groups taking the new treatment at different doses, to show which dose works best and has the fewest side effects.
Another group, the control group, takes an approved treatment (such as AZT, ddI, ddC or) to see how it works in comparison with the new one.
Sometimes the control group takes a substance that does nothing (known as a placebo). Usually no one - not even the doctors - knows who’s taking what until the trial is over. This is called a double blind study.
Controlled trials are done to make sure that the treatment really works. If everyone in the trial gets the new treatment, there’s no way to tell if it’s the treatment making them better or if something else is doing it. They may be getting better because they’re seeing a doctor regularly, or because they’re eating better or taking better care of themselves. So a new treatment is compared to something else to see which is more effective.
Also, if people in the trial believe they’re taking a treatment that works, they may feel better, even if the treatment does not work or they are receiving a placebo. (Feeling better from taking an inactive substance, or placebo, is known as the “placebo effect.”) For example, in a trial to test a treatment to fight diarrhea, half the people who took the new treatment got better. But half the people who took the placebo got better, too. This means the treatment did not work any better than the placebo.
After a treatment has been tested in the lab and on animals, it’s tested on people. There are four steps, or phases, of trials done with people.
Phase 1: Is the treatment safe?
A Phase 1 trial is the first time the treatment is given to people. It’s meant to find out how the treatment is safe. In particular, the researchers are concerned with bad effects which might be caused by the treatment. These range from bad breath, headaches, nausea, and vomiting to more dangerous, and even life-threatening, reactions. It’s important to find out how much of the treatment can be taken without causing serious side effects, as well as what side effects might appear. Everyone in a Phase 1 trial gets some of the treatment, but since these trials sometimes try to find out the best dose (amount) of the treatment, different people are sometimes given different doses.
A treatment in Phase 1 has not been tested on people at all, so very little is known about it. This makes Phase 1 trials riskier than Phase 2 trials. Phase 1 trials are usually three months long or less, and usually involve about a dozen people. As well as studying how a treatment is safe, they may also collect early information on how well it works.
Phase 2: Does it work?
If a Phase 1 trial finds that the treatment is safe enough, a Phase 2 trial is done. In this phase, more people are given the treatment to see whether it works at the dose figured out from Phase 1, and to study the effects more carefully. Researchers try to find out whether the treatment is effective, for example, does it raise your T4 cell count or clear up an infection? Phase 2 trials can last from a few weeks to a few months and may involve fewer than 100 people.
Phase 3: How well does it work?
If the Phase 2 trial shows that the treatment seems to work, a Phase 3 trial is started. By this time, the researchers have information about the most common side effects and the best dose to take. In a Phase 3 trial, usually hundreds or thousands of people are given the treatment to see whether it works for most people and whether it causes problems over a longer period of time. Researchers look for rare side effects that only show up in a few people or after a few years. So Phase 3 trials may go on for several years.
Combined phases
Treatments usually have to go through all three phases before they’re approved by the Health Protection Branch. But phases are sometimes combined in order to answer more than one question at a time or to speed up the approval and availability of the treatment. For example, Phase 1 and 2, or Phases 2 and 3, can be combined into one trial.
Phase 4: Post-marketing trials
Researchers do not always do post-marketing trials - trials done after the medicine is available at drug stores - but these are becoming more important now that some treatments are approved earlier than in the past. They allow for more testing over a longer period of time, to see whether any problems develop over the long term.
Clinical trials are usually not done for complementary treatments such as herbs or homeopathic remedies, or for therapies like acupuncture or massage. This is slowly starting to change, and there are a few trials involving complementary therapies. These studies tend to be smaller and have been run by hospitals, universities, or AIDS groups. In evaluating complementary therapies, you may find it useful to talk to friends who have already tried them, or to other people living with HIV or AIDS. Another possibility is to refer to alternative medical and health publications. Some AIDS groups receive such publications and / or keep files on complementary therapies.
A clinical trial is a scientific experiment, sponsored by the maker of the treatment under study or an institution like a hospital or university, in which people take a certain treatment to find out whether it’s safe and whether it works. If treatments were made available without testing, there would be no information about them. Because not everything is known about a treatment when it’s being tested in a clinical trial, there is some risk involved if you choose to participate in one. It’s important to keep in mind that many clinical trials to discover that treatment does not work.
Clinical trials do not always provide completely accurate information about the treatments being tested. Sometimes the information learned from a trial proves to be inaccurate over time, or as more people use the treatment. Some clinical trials are poorly designed. So you should be cautious about how you use the information that comes from a trial.
Every treatment sold in Canada must be approved by Health Canada’s Health Protection Branch (HPB). The HPB looks at the information from clinical trials to see how a treatment is safe and how well it works. If a treatment is approved by the HPB, then the company that makes it can sell it. Except in special cases, it’s against the law to sell a treatment that has not been approved by the HPB.
When the BPH approves a treatment that does not mean the treatment will work all the time for everyone. It means that it works often enough, in enough people, to make it worth trying. It does not mean that the treatment is totally safe, either - only that most of the dangers are known and that the benefits outweigh the risks for most people.