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Clinical Trials |
Clinical TrialsFrequently Asked Questions Why should I participate? Participating in a clinical trial allows you to play an active role in your own health care. It may allow you to try a new treatment before it is widely available. You will also usually receive free medication and medical care related to the condition being studied. It is also a way to help others, as the information obtained through clinical trials contributes to medical knowledge about the disease. In turn this information improves treatment for future individuals. Who can participate? All clinical trials have guidelines about who can participate, based on the questions the research is seeking to answer. Some trials seek participants with certain conditions, while others need healthy participants. There are also criteria such as age, gender, other medical conditions and previous treatment history that may be looked at. What is mental health clinical research? Researchers perform studies in human volunteers to answer specific questions about mental health. Clinical trials are the fastest and safest way to find treatments that work in people and ways to improve mental health. Some clinical research evaluates how well a treatment works; while some clinical trials test new treatments and others look at ways to improve quality of life. A clinical study might also study factors that affect mental illness. Will I get paid? Usually you will receive free study medication and free visits to the doctor/nurse in relation to the condition being studied. Sometimes there is financial compensation for an expense that you incur, such as travel to participate in the clinical trial. How much time will this take? The amount of time that you will be required to dedicate to a clinical trial varies with each trial. Trial lengths range from a few weeks to a few months and the number of visits varies as well. How will treatment in a clinical research study be different from regular doctor visits? When you visit your regular doctor, you expect him to provide the treatment that is best for you. In clinical research, the doctor's goal is to learn about your condition, not only treat you. In research there are standardized procedures that the researcher may not be able to tailor to fit your immediate needs. How am I protected? Each proposed study has to be approved by an institutional review board (also known as an ethical review board), made up of scientists, non-scientists and public advocates. They ensure that the rights of study participants are protected, through examination of the scientific plan and study procedures. Federal regulations have also been created to protect the rights of volunteers in biomedical research. The research physician has to get your informed consent before doing any study related procedures. There is a document called The Informed Consent, that contains a description of the study, possible risks, and benefits from the research. It is not a contract; you may withdraw from the trial at any time. What if I want to drop out? Participating in a clinical trial is voluntary. If you change your mind and decide that you want to drop out, you will not be penalized. You can withdraw at any time with no negative consequence. As a courtesy, please let the research team know why you no longer want to participate in the clinical trial. Will I have access to the drugs that worked after the trial is complete? In some cases, if the medication you are taking has been approved by the Food and Drug Administration your doctor may prescribe it to you. In other instances, the medication may not be available if the manufacturer of the drug wants to further test the drug. What are the risks in clinical trials? The treatment may not be effective for you and your condition could worsen. If this happens, you will be withdrawn from the study and given immediate care. There may also be side effects associated with the treatment. Where do I get treatment after the clinical trial has ended? We will provide follow up care and help you transition back into a program of care suitable for you. Who sponsors clinical trials? Clinical trials are funded by a variety of organizations or individuals such as medical institutions and pharmaceutical companies. They are also funded by Federal agencies such as the National Institute of Mental Health. |
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