A clinical trial, or clinical research study, is a scientific investigation designed to find new ways to treat diseases and improve care. Before the general public can use new drugs and devices, they have to be tested in smaller groups of people to make sure they are both safe and effective. Clinical trials are a vital part of the medical treatment development and approval process.

Participating in a clinical trial gives you a chance to play an active part in your own care. Your participation helps others, too. When you participate in a clinical trial at Baptist Health, you benefit from:

• Active participation in advancing the future of medicine. When you participate in a clinical trial, you plan an active role not only in your own care, but in developing care for future patients. Your participation contributes to medical research, even if you don’t receive any direct benefit from the research.
• Early access to new therapies. Clinical trials often test new therapies not yet available to other patients. These promising new therapies may be more effective than standard treatments. By participating in a clinical trial, you may get access to an investigational drug or procedure you would not otherwise be able to receive at that time.
• Expert care and monitoring. Every patient at Baptist Health receives expert medical cancer and close monitoring. This includes patients participating in clinical trials.

Before you can take part in a clinical trial, you must first be screened to be sure you are right for the study and that the study is right for you. All studies will follow established guidelines describing who should be included in or excluded from the study. Sometimes, a study will be looking for people with a particular medical condition, and sometimes a study will want healthy volunteers.

If our doctors or nurses think you are a good candidate for one of our trials or studies, they will contact you with more details.

If you want to learn more about clinical trial opportunities at Baptist Health Brain & Spine Care, talk with your doctor or view a list of current clinical trials.

We do everything we can to keep you safe during a clinical trial. Still, there are risks to participating in clinical research. These risks include:

• Unknown side effects. Many clinical trials test multiple therapies or combinations of therapies. Because clinical trials often test new treatments, side effects may not be known or well understood.
• Lack of control. Most clinical trials are designed as randomized studies. This means participants cannot choose the therapy they receive. Instead, they are randomly assigned to a specific therapy or therapy combination being tested.
• Ineffective treatments. Not all therapies studied in clinical trials are found to be better than therapies available today. This means you may be part of a study testing a treatment that isn’t better than the current standard of care. Doctors will monitor you closely during a clinical trial to be sure you receive the best available care.

Talk to your doctor if you have concerns about participating in a clinical trial.

Below are some questions to consider before agreeing to participate in a clinical trial.

• What is the purpose of this study?
• Who will be in the study?
• How will it help me or other patients?
• Why do the investigators think the drug or procedure being tested may be effective? Has it been tested before?
• What side effects might I experience?
• What other treatment options are available?
• How do the possible risks and benefits compare with the treatment I am getting now?
• Are there possible long-term risks?
• How will participating in this study affect my daily life?
• What are the treatments, medical tests or procedures I will undergo during the study?
• Will hospitalization be required?
• Who will oversee my care?
• How long will the study last?
• Am I willing to be assigned (randomized) to either study group? Will I be satisfied with this decision while I am participating in this study?
• Who will pay for the study drug and procedures?
• Will I or my insurance carrier be billed for medical expenses relating to, or arising from, this study?
• Will my health insurance cover treatments and tests I receive as part of this study?
• Will I be reimbursed for any expenses?
• What kind of follow-up care will I receive after the study?
• How will I know if the study drug or procedure is working? Will the results of the study be provided to me?
• Who should I contact if I have any questions?

The same ethical and legal requirements that govern the practice of medicine apply to clinical studies. Clinical research studies are closely controlled and have built-in safeguards. Investigators are required by law to follow specific procedures. You will be monitored frequently to check your health and progress.

All clinical studies must be preapproved by an Institutional Review Board (IRB) before participants can be enrolled. The IRB is an independent group made up of both medical experts and someone from the community. It is the IRB’s job to make sure the study is as safe as possible and worth the risks involved. In addition to reviewing and approving the study, the IRB will also periodically review its progress. If you choose to participate in a study, you will be asked to sign a consent form that explains the study. However, even if you sign the consent form, you may stop participating in the study at any time.