|
How Are Clinical Studies of Mental Disorders Designed?
Clinical researchers call the standard scientific approach for trying out treatments a double-blind, randomized, controlled clinical trial. Understanding this term, and knowing how and why this approach is used, should help you to decide whether to become a research volunteer.
Why Do Patients Participate in Research on Mental Disorders?
Although remarkable progress has been made in defining and treating mental illnesses, some treatments are not effective for all persons or may have significant side effects. Thus, most people who agree to take part in studies of mental illness hope the research will produce knowledge about the disease itself — for example, the role of genetics in illness — or about treatments that will benefit them directly.
Will You Have Access to Those Drugs That Work After a Trial Is Complete?
Often, the company developing a new drug may try to see that you can continue to get it, even before the FDA has approved it for sale. You may be able to do this under what is termed a compassionate plea basis. This means that because the new drug has been so helpful, the manufacturer can give it to a physician, who may then prescribe it for you.
Checklist of Questions
So, you're considering taking part in a clinical trial...This can be a very satisfying experience, allowing you to help yourself now and to help others in the future. But what questions should you ask to help you make sure you really want to take part, and, if you do decide to go ahead, what should you expect along the way?
What Is a "Placebo Control" in a Medication Trial?
Studies of new drugs often compare the effects of an investigational drug with the effects of a placebo. If you are considering whether to take part in a drug trial, the director of the study must tell you if the study will use a placebo control. The informed consent form that you will sign if you agree to join the study must also explain any plans to use a placebo control
Learning About the Results of Research
In most informed consent forms, the researcher promises to share what is learned from the study with you. These results will sum up the responses of everyone who took part in the study. In addition, the researcher will discuss with you any results that relate to your diagnosis or that may be useful in deciding on the best treatment for your disorder.
|
