Clinical Trials

Clinical trials follow standards and are highly regulated to protect participants. Every trial is closely monitored by an independent Ethics Committee (EC) or Institutional Review Board to safeguard the rights and welfare of participants. Nevertheless, clinical trials cannot be risk-free. Although safety precautions are in place to protect people who participate in clinical trials, your condition or health could remain the same, improve or get worse.

An Institutional Review Board (IRB) or an Ethics Committee (EC) is an independent group of doctors, scientists, and lay people - just like you - who are dedicated to making sure that the clinical trial participants are not exposed to unnecessary risks. The IRB or EC regularly reviews clinical trials and their results. They make sure that risks (or potential harm) to participants are as low as possible.

Clinical research is done in phases. A drug or treatment being studied in a clinical trial is considered investigational or experimental because it has not been approved for use.

• Phase I trials evaluate safety and collect information about side effects. Some phase I clinical trials only look for healthy volunteers, who may be compensated for participating. Learn more about healthy volunteer clinical trials.
• Phase II trials evaluate effectiveness (does it work?) and collect additional information about safety and side effects. Often this is the first time a drug is tested in people living with the disease.
• Phase III trials evaluate a drug or treatment in large groups of people worldwide to confirm effectiveness, monitor side effects, compare it to commonly used treatments, and collect additional information that will allow it to be used safely.
• Phase IV trials take place after a drug or treatment is approved for use. These trials provide additional information about risks, benefits, and best use of the drug or treatment.

The research team will explain the trial to you and review an informed consent document (ICD) with you. This document describes what will happen during the trial. You can take as much time as you need to ask questions and review the ICD before deciding if you want to be in the trial. If you decide to join the trial, you will be asked to sign the ICD. By signing the document, you show that you have been told all the details and want to be part of the study. You will receive a copy of the ICD to keep for your reference. You can also ask questions throughout the trial so that you continue to understand what will happen.

If you want to be in a clinical trial, you will undergo a screening process to see if you meet all the requirements for participating in the trial. As part of the screening process, you will need to answer questions about your medical history, prior and current treatments and medications, and other issues that may affect your ability to participate in the trial. You may also need to have some medical tests and procedures done as part of the screening process. The research staff and physician(s) from the trial site will go over this information with you, and it will also be outlined in the informed consent document.

While taking part in a clinical trial, you will need to:

• Follow instructions from the research team
• Attend trial-related appointments
• Complete scheduled activities, such as recording when you take your medication
• Inform the research team about any changes to your health or study medication side effects
• Comply with trial-specific requirements, as described in the informed consent document

Trial-related activities depend on the type of research being done and can vary from one appointment to the next. Activities may include (but are not limited to):

• Receive an investigational drug or treatment
• Discuss changes to your health and other medications you may be taking
• Complete questionnaires about your health
• Have medical procedures done, such as physical exams and blood draws

An investigational drug or treatment is not yet approved for the use being studied, and can only be given as part of a clinical trial.

A placebo looks like an investigational drug but contains no active medicine. A placebo is often used in a clinical trial to help evaluate an investigational drug by comparing the effects seen in participants who take the investigational drug versus those who take the placebo.

If you have questions or concerns about any aspect of the trial, you should feel comfortable discussing them with the research team at any time. You can also talk with your regular doctor about the clinical trial.

Taking part in a clinical trial is voluntary. If the research team determines that you can be in the trial, you may choose to participate or not participate. If you choose to participate, you may change your mind at any time and leave the trial for any reason. This will not affect your regular medical care or any medical benefits you had before joining the trial.