About Clinical Research
What is a clinical research study?
Clinical research studies (also called clinical trials) are scientific studies that test whether an investigational medication is safe and effective in treating people with certain diseases and conditions. Before any medication can be approved and made available to the public, it has to go through several phases of clinical research.
Research studies on people are only started after significant research has already been done on an investigational medication or device. The study medication is considered investigational until it has passed all phases of clinical research successfully and has been approved by the U.S. Food and Drug Administration (FDA).
Why participate in clinical research studies?
Many treatments used today are the result of past clinical studies. Participating in a clinical research study may help researchers learn more about a disease and potential treatments for that disease. The information gathered from clinical research studies may help patients with that disease in the future.
Participating in a study is also a way for you to learn more about your disease and how to take care of your health. As a study participant, your health will be closely monitored under the guidance of the study doctor.
All investigational medications and study-related tests and procedures will be provided at no cost to you.
Why is participating in clinical research studies for Sickle Cell Disease important?
Because there are very limited treatment options currently available for patients with Sickle Cell Disease, more clinical research studies are necessary to learn more about how Sickle Cell Disease works and whether drugs currently being researched are effective in people with Sickle Cell Disease.
What are the potential risks and benefits of study participation?
The study staff will explain all of the potential risks and benefits of participation. Before choosing to take part in the study, read all the information the study staff provides and ask questions about the study. The study staff can answer any questions you may have about study procedures or potential risks and benefits of study participation.
Are clinical studies safe?
Clinical research studies follow a specific set of standards and are closely regulated to ensure the safety of all participants. Safety precautions are put in place to protect people who participate in clinical research. In addition, studies follow a written plan that is called a protocol. The protocol is designed to make sure all study procedures are conducted correctly and safely.
What if I have questions during the study?
You can ask questions of the study team at any point before, during, and after the study. Before agreeing to participate, please make sure that you understand the responsibilities of study participation. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.
The study staff will review a written Informed Consent Form (ICF) with you that explains what will happen during the study, what is expected of a study participant, and known risks and potential benefits of the investigational medication. Talk with your doctor, family, and friends, and ask the study doctor questions about the study before you decide to sign the informed consent form and participate.
Can I leave the study once it has started?
Participation in a clinical study is completely voluntary. Volunteers can stop participating at any time, for any reason. Doing so will in no way affect the care provided to you now or in the future. If you think you would like to stop participating in the study, talk to the study doctor. If you decide you should leave the study early, the study doctor may ask that you return to the study site for a final visit.
Will my medical information remain private?
The study doctors and their staff respect your privacy. Details about your health will not be shared with anyone who is not associated with this research study unless you have given your permission or except as required by law.
Can I see other doctors during the study?
You can visit any doctor to meet your needs during the study. Please let the study doctor know that you will be seeing another doctor and if any medication is prescribed during the visit.