What are clinical research studies?
Clinical research studies are designed to test the safety and effectiveness of investigational study drugs. Before any drug can be available to the general public, it has to go through multiple phases of research.
All clinical research studies follow strict guidelines to help make sure that the rights and health of participants are protected during the study while allowing researchers to collect valuable information about the investigational study drug.
What is informed consent?
Informed consent is the process that allows you to learn the facts about participating in a clinical research study.
The study team will take you through a written Informed Consent Form (ICF) that describes the information you should consider before considering joining the study. They will review your medical history with you to see if your profile matches the requirements for participation in the study. The study team will also answer any questions you may have about the study.
The informed consent form provides details of the study, like the duration of the study, study expectations, and what you will need to do. All known possible risks and potential benefits are also explained in the ICF. After you have read and talked about all of the information with the study team, you can decide whether or not to sign the consent form. Even after you sign the consent form, you are always free to leave the study at any time and for any reason.
During your participation in the study, the study team will keep you up to date with any information that may change your mind about participating.
What is a placebo?
If there’s no approved treatment for an illness or condition, some people in the study may be given a placebo, while others get the investigational study drug being tested. A placebo is a substance that looks just like a regular active treatment or medicine, but is actually an inactive “look-alike” treatment or substance. A placebo is not intended to have any effect on the body. This means it’s not a medicine.
Typically, the person getting a placebo doesn’t know for sure that it is not the real medicine. The main reason to have a placebo group in a clinical research study is to be sure that any effects that happen are actually caused by the treatment and not some other factor.
The placebo being used in the RESET clinical research study is a saline (salt water) solution given as an intravenous infusion.
What to consider before participating in a clinical research study?
There could be risks when participating in a clinical research study. Some of these risks are known, and some may not yet be known. The investigational study drug may possibly cause side effects and may provide no medical benefit.
Participation in a clinical research study is an important decision and should be carefully thought out. You should never feel forced to participate in a clinical research study. Even if you join the study, you can cancel your participation at any time and for any reason. You will have the right to receive the same standard of treatment as you did before joining. A study doctor will discuss other treatment options that may be available to you.
Why should I participate in a clinical research study?
Every prescription, pill or drug you have taken for any sickness would not be available without clinical research. New treatments can only be approved and available to the public for use after they have passed through a program of clinical studies.
The research community relies on people being willing to participate in clinical research to help provide treatment alternatives for sickle cell disease.
Your participation would help to find out if an investigational drug might possibly reduce the amount of time a person in a serious pain episode has to spend in the hospital—and whether they might not have to use so much opioid pain medicine.
- Access to investigational study drugs
By participating in a clinical research study, you may gain access to investigational study drugs that would otherwise not be available, and contribute to medical research, which may also help people in the future.
- Hospital care and related treatment
Your hospital care will be undertaken by a clinical research study team comprised of doctors, nurses and other medical professionals who are committed to your well-being and to research that may lead to future treatment options for sickle cell disease.
- An open door
Remember, there is no guarantee that you will benefit by participating in this clinical research study, and if you choose to participate, you are free to withdraw at any time, and for any reason. If you decide to withdraw from the study, you will have the right to receive the same standard of treatment as you did before joining, and a study doctor will discuss other treatment options that may be available to you.