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What is a clinical research study?
Clinical research studies are carefully designed to test the effects of a medication or other psychiatric treatment approaches on volunteer participants.This research is an important step in developing new medications, therapeutic interventions or understanding the effects of current medications. They measure the drug's or treatment's ability to treat a condition, its safety, and its possible side effects.
Why do patients participant in research on mental disorders?
- Most people who agree to take part in research studies of mental illness hope the research will produce greater knowledge about the disease itself, about treatment that will benefit them directly or others who suffer from similar ailments.
- Participating may allow you to try a new treatment before it is widely available to the public.
- You may receive a higher level of diagnostic accuracy and better monitoring of treatment effects and side effects that you might not receive otherwise.
- Some people suffering from psychiatric illness do not have access to medications on the market because they have no insurance, no doctor, or cannot afford to pay for doctor visits and medications. Clinical research studies provide psychiatric and some medical evaluations, monitoring of the illness and treatment response, and study medication, at no cost to participants.
What is informed consent?
Informed consent is the process for giving research study participants the information they need to decide whether to volunteer for the study. The clinical investigator reviews the information with potential volunteers, discussing all known risks and answering questions. An informed consent must be obtained from each research volunteer before that person can participate in the study. Informed consent is a continuing process. Throughout a study, the research team must continue to answer any questions and inform participants if any new risks are identified. Participants may at any time review their decision to take part in the study and can withdraw form a study at any time.
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How does treatment in a clinical research study differ from treatment by a personal physician?
In a treatment research project, patient safety and care remains the primary objective. The research team insures that the risk associated with participating is as small as possible. In doing so, the process of diagnosis and follow-up treatment is lengthy and offers the highest possible standard of precision and accuracy. In some cases, you may receive an inactive pill, called a placebo, rather than the investigational drug being studied. If you do not benefit from participating in a research study, the Rogers Center can help you find other avenues of treatment.
Do volunteers have access to the study's investigational drugs after the study is completed?
Medications that are being investigated in research studies may have been approved by the Food and Drug Administration (FDA) for other uses. If participants find that they benefit from a certain mediation, their personal physician can prescribe it. Also, the company developing a new drug may try to see that these participants can continue to obtain it even before the FDA approved it for sale through what is call a compassionate program. This means that because the new drug has been helpful to certain participants, the manufacturer can give it to those paritcipants' physicians, who may then prescribe the drug for continued use. If the mediation being researched has not yet been FDA approved and there are no compassionate programs available, the mediation will not be available for further use. However, often medications with similar benefits can be substituted.
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What are the risks involved?
A drug or treatment that is being studied has been evaluation for safety and proven to the Food and Drug Administration (FDA) to be reasonably safe for further study. Treatments that reach this phase of evaluation have been studied for three to ten years on animals and healthy human subjects before the drug or treatment is tested with volunteers. Yet, for research to be absolutely "risk-free," every possible outcome would have to be known- and if this were the case, research would not be necessary.
Each research study is reviewed and monitored by the Institutional Review Board (IRB), a group of health care professionals and members of the local community that must approve the study before it begins. The IRB's primary responsibility is to protect the safety and rights to study participants. All clinical research must adhere to strict study protocols and good clinical practice guidelines under the code of federal regulations, and are watched closely by the IRB and FDA. In addition, the study must adhere to the protocols of Rogers Memorial Hospital's Human Subject Committee.
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How can volunteers obtain care after a research study has ended?
Volunteers who decide to take part in a research study, especially inpatient studies which require a hospital stay, may have to stop or interrupt the care they were receiving for a mental health disorder. The staff at the Rogers Center for Research and Training can help participants re-join a treatment program or assist in arranging follow-up care once the study is finished.
How can I learn more about current trials at the Rogers Center for Research and Training?
For more information, please call the Rogers Center for Research and Training at
414-328-3706, toll-free at 1-877-676-6600, or call our informational 24/7 hotline at 414-328-3740. You may also email us at: trials@rogershospital.org.
Rogers Memorial Hospital - Milwaukee
11101 West Lincoln Avenue
Milwaukee, WI 53227
1-877-676-6600
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