Because clinical studies affect your health, it’s smart to ask questions about them before you join. Here are straight answers to the questions we’re most often asked.
It’s one of the final steps in a long and careful process every new medical treatment goes through before gaining FDA approval. Clinical studies and all of the people who took part in them are behind every medication in your pharmacy today.
Studies answer scientific questions that lead to new and better medical treatments. Without clinical studies, there would be no new medicines and improvements in healthcare would not be possible.
Clinical studies follow rules designed to protect participants’ safety. An Institutional Review Board (IRB) monitors all studies to make sure the rules are followed. IRB members include doctors and people from other professions, such as teachers and religious leaders. The ethical and legal codes that govern medical practice also apply to studies.
Some studies evaluate promising new drugs. Before these new drugs are used on people they’ve been through approximately 10 years of careful scientific research. Other studies evaluate new ways to use existing medications or new combinations of FDA approved medications.
Before deciding to participate in a clinical research study, you should learn as much as possible about the study. The Encompass staff will answer all of these questions in a way that you can easily understand.
1. What is the main purpose of this study?
2. Does the study involve a new investigational medication or one that is already on the market?
3. Is a placebo used in the study?
4. How will the study medication be administered?
5. How long does the study last and how many study appointments will I have?
6. What will I be asked to do as a participant?
7. What kinds of lab tests, scans, and other procedures will I have during the study?
8. Will I be able to take my regular medications during the study?
9. What medications, procedures, or treatments must I avoid during the study?
10. What are the possible benefits of participating in this study?
11. What are the possible risks of participating in this study?
12. Who do I contact if I experience side effects or problems during the study?
13. Will I be able to see my own doctor during the study?
14. If the study medication works for me, can I keep using it after the study?
15. Will I receive any follow-up care after the study has ended?