I was asked to join a research study that is testing a new medication for my condition. I'm not happy with the medication I'm on now, but the idea of research makes me very nervous. What should I do?
(Column: Ask the Doctor)
Joining a Research Study
Peter Weiden, M.D.
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Weiden is a professor at the State University of New York, Downstate Medical Center, and is Director of the Schizophrenia Research Program there. He is a strong advocate, a wonderful physician, and conducts many medication research trials. Since our question is about taking part in research, he seemed the perfect person to write this column. - Stephen Goldfinger, M.D.
There's no right or wrong answer here, but one thing is for sure. There are many new psychiatric medications being developed. For a new drug to get approved by the FDA, it needs to be tested in research studies to make sure that it works and is safe. Doctors need to find people to join these studies; so joining a research study is one way to (possibly) try a new medication. In principle, these studies offer the option of being among the first to try a new medication, which could be a good thing if you've already tried most of the new medications and aren't completely satisfied with your current meds. You do need to know that research studies may have some drawbacks. Ill go over these possible drawbacks so you can ask about them when you talk to your doctor about joining a research study.

Why do they do research studies with these medications? The most common reason these medication studies are done is to show the FDA that the medication is safe and that it works for your condition. For a medication to be approved as an antipsychotic for the treatment of schizophrenia, it has to work well for positive and negative symptoms. To show effectiveness, the pharmaceutical companies set up large research studies that are called clinical trials. Frequently, the same study is done at many different sites throughout the country -- these are called multi-center clinical trials.

What is a clinical trial? In a clinical trial, the medication being tested is compared to either a placebo (an inactive sugar pill) or another medication that is already known to work. Unlike most situations where doctors prescribe a medication, the decision about who gets what medication isn't up to you or the doctor. The decision is made by a process similar to flipping a coin -- heads you get one drug, tails the other. This process is called random-assignment. This means that you might not get the new treatment that you hope to get. Most of the time, you and your doctor wont know your assignment. Its kept secret, and the medication is packaged in a way that you wont be able to figure out your assignment by how the medication looks. This is called double-blind, meaning that both you and your doctors are blind to your treatment.

What does all this mean for me? Most important, you need to know that the main goal of a clinical trial is the information it gives the pharmaceutical company or the researcher. Your own treatment is not the main goal of the research study. This is not to say that you wont get good care. In fact, my experience is that many people get better care when they participate in clinical trials than they would otherwise get.

Why do doctors (investigators) do clinical trials? Doctors do clinical trials for two main reasons. One reason is that they really want to be part of finding better and more effective medications, or want to learn more about the pros and cons of the medications being studied. This means that many investigators are experts in the treatment of your condition. By joining a clinical trial, you may get an evaluation from a top specialist in your condition. Another reason that doctors do clinical trials is that they are paid to do the research. The investigator usually receives a payment from the sponsor of the study if you join the study. This payment system has its pros and cons. The advantage for you is that you probably wont be charged for your evaluation and treatment. The disadvantage is that you may be concerned that the investigator has a financial conflict of interest, and is trying to pressure you to participate in the study for his or her own financial reasons.

Why should you consider participating in research? In my experience, the three most common reasons are:

To find a medication that works better for you
To get care that is free of charge from a research staff that is very knowledgeable about your condition
To help other people who suffer from the same illness
Lets look at these reasons and review what questions you need to consider before joining a study.
Can I get on a better medication? You should ask the doctor about what's known about the new medication. One tip I can give you is also to ask which phase of development the medication is in. Generally speaking, doctors tend to know a lot more about medications that are further along in the development process. The key word here is which phase the medication is in. Phase II is pretty early in testing, and Phase III means that the medication is pretty far along in development and has already been tried on lots of people. You'll be more likely to get on a medication that works better for you in a Phase III study. That doesn't mean that you shouldn't enter a Phase II study. It just means that if your major reason for joining is to get a better medication, you've got better chances with a Phase III study than a Phase II study.

Here are some questions you might want to ask before agreeing to the study:

What does the comparison group get? Is it a placebo? Is it a medication I've already tried? What are the chances Ill be in the comparison group?
If I do well on the study medication, can I stay on it after the study ends?
If I start out in the group that didn't get the new drug, will I later have the opportunity to try the new medication?
Getting better care: One possible advantage of a research study is that you'll get care that is free of charge from clinicians who are experts in your conditions. In running my own clinical trials service, I've found that we are able to help many patients simply by doing a careful reassessment of their medical and psychiatric problems. Often these kinds of advantages are even more helpful than the research medication! Of course, there may be some drawbacks. Sometimes people have to change doctors to join a study, and that can be very hard when you have a good working relationship with your current doctor. Another problem is what happens at the end of the study. The research team may refer you to another treatment system, and you have your treatment disrupted again. Here are some questions you might want to ask:
Have you spoken to my current doctor? Does he or she agree with this study?
Will I change doctors? Will I be able to stay in contact with my old doctor during the study? Can I go back to my old doctor at the end of the study?
Who will be taking care of me during the study?
What happens at the end of the study? Will I continue to get care here, or will I be referred elsewhere?
Who will pay for the medications once the study ends?
Helping others: Another very important reason to join a research study is to help others. People who participate in clinical trials are helping others. Even if a new medication or treatment doesn't work for you, the information that is obtained from your participation always helps others. Remember, others in the past took part in the studies that helped the medication you are now on be available for YOU!
To summarize Dr. Weiden's answer: Joining a clinical research study isn't for everyone, but it is becoming one of the best ways to get access to new medications and care from experts in your condition. If you do join a study, remember that the goals of the study may not be the same as your own goals. If so, you'll need to review the pros and cons of the study to see if it is worth the chance.

Neither he nor I can be objective, but I think people often get excellent care when they join research studies. One word of advice: spend time beforehand asking these questions, and take your time deciding. But, if you do decide to join the study, then you should do your best to stay with the program. Often it takes time and patience to figure out whether the treatment is good for you. - Stephen Goldfinger, M.D.
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