Things to Consider Before Participating in a Clinical Trial:
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Many factors enter into the decision to participate in a clinical drug study. Please read the information below if you are interested in participating in a study.
- Explore whether it is in your best interest to enroll. You may want to contact your doctor. If your doctor agrees that enrolling would be beneficial, contact Four Rivers Clinical Research to learn more about our enrolling studies.
- Be prepared to answer questions about your condition. When you contact a study center, your initial conversation with researchers will usually include a phone interview to determine your eligibility for the study. You may need to provide information about when a diagnosis was made if you are in generally good health. For dementia studies, the researchers also will want to know if a caregiver will be available to assist you throughout the duration of the study, and if you live at home.
- Additional testing may be needed to determine eligibility. Your first visit to the study center may include an assessment of medical and/or psychiatric history, physical and sometimes neurological examinations, an imaging study (X-Rays, a CT scan, or MRI), and usually blood and urine tests. All study-related examinations, assessments, and study medications are provided to the participant at no cost.
- Be aware of the responsibility involved in participating. Volunteering requires a time commitment from individuals with the condition as well as their caregivers if they are required by the study. Researchers conducting the study rely on participants and caregivers to administer the drug according to schedule, return to the study site for regular follow-up visits, and report any changes in the participant’s condition or behavior.
- Understand that clinical studies determine the effectiveness and safety of a drug. Volunteering may involve some risk, since the treatments being tested are still considered experimental.
- Understand that not all participants are given the medication being tested. In almost every study, participants are divided into two groups — an experimental group (which receives the active drug) and a control group (which receives a placebo, or “sugar pill”). Neither the participants nor the researchers know who is taking the active drug and who is in the placebo group. A third party involved in collecting data for the study records this information and releases it to the researchers and participants once the study is completed. This type of study design — a double-blind, placebo-controlled study — lets researchers compare the effects of the actual drug to those of a placebo without allowing their personal opinions about the drug to influence observations being made during the study.
- Realize that individuals receiving the placebo are just as important as those receiving the experimental drug. They also may benefit from the increased medical attention. Often placebo-controlled studies are followed by extension studies. In the extension study, all participants recieve the experimental drug.
It is important to ask questions when considering participation in a clinical trial. Ask for clarification about the study, what will be involved as it progresses, and discuss anything that makes you feel uncomfortable about participating. The researcher should be able to answer any questions you may have throughout the duration of the study. If you are not satisfied with the answers at any time, then it may be best to discontinue your involvement with the study.
Remember, not everyone will be willing or eligible to become a research participant. For those who do participate, there is the satisfaction of being involved in the development of a potential treatment for your condition as well as the possibility that the experimental drug may benefit the individual with the condition.
Adapted from the Alzheimer's Disease Association