People of all ages, races and ethnicities, healthy and with pre-existing conditions, participate in clinical trial research all over the world. And so can you. Clinical trials bring the hope of new medicines and medical devices to reality for many of today’s challenging conditions. Explore whether a clinical trial might be right for you.
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Clinical trials help determine if medications, vaccines, medical devices, and medical procedures are safe and effective for treating or preventing diseases and health conditions. Without clinical trials, we have no new treatments. So, by joining a clinical trial you contribute to meaningful change in our world.
Although there are no promises of direct benefits, people choose to take part in clinical trials for a variety of reasons, such as:
Research comes with risks, and a clinical trial is no exception. Potential risks from being in a clinical trial include (but are not limited to):
You should learn as much as possible about a clinical trial before deciding if you want to join the trial. Here are some questions you may want to ask.
Some people need help from loved ones or care partners to participate in a clinical trial. A child, an elderly person, or someone whose health condition makes certain activities more difficult all deserve the same clinical trial opportunities that others have. Your loved one or care partner may be asked to:
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.
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:
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):
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.
