How to Join a Clinical Trial
There are several ways to find out about clinical trials. Your doctor may suggest one, if you are a good candidate. A friend, relative, or member of a support group may mention it. You can search our database of trials. Or you can do research to find a clinical trial that is appropriate.
Once you find out about a clinical trial, you’ll need to find out if you are eligible to participate. All clinical trials have a set of standards to ensure that there is a consistent group of volunteers. We call these standards Eligibility Criteria. Consistency makes it easier to analyze the study results. Criteria might include age, gender, type and stage of disease, previous medical history, and other medical conditions. Some clinical studies need volunteers with a particular condition or illness. Others need healthy participants.
The first step is called Informed Consent. At this stage, you meet with the researchers (also called principal investigators or PIs) and discuss the purpose and requirements of the study as well as the potential risks and benefits of volunteering. If you do not speak English, we can provide a translator.
After you have this discussion, the research team will give you an Informed Consent Form that outlines the purpose, duration, procedures, and key contacts for the study. It will also explain the risks and potential benefits. You decide whether you want to participate in the study, and whether you want to sign the form. We will give you a copy of the signed form. You can withdraw from a clinical trial at any time.
Questions to Ask
As with any other medical appointment, you can make a list of questions in advance. You can also ask a friend or relative to come along for support and to hear what the researchers have to say, or bring a tape recorder to record the conversation so you can replay it later. Some questions you might consider asking are:
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the new treatment being tested may be effective? Has it been tested before?
- What kinds of tests and treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
Risks and Benefits
As with any other health care decision, there are risks and benefits. Some of the benefits of participating in a clinical trial are:
- You get to play an active role in your own health care.
- You gain access to new research treatments before they are widely available.
- Medical experts provide close monitoring, advice, and care at leading health care facilities during the clinical trial.
- You help others current and future patients by contributing to medical research.
Some of the risks associated with volunteering in a clinical trial are:
- You may have unpleasant, serious, or even life-threatening side effects.
- Clinical trials might include more doctor visits, treatment sessions, and hospital stays than traditional treatment.
- The clinical trial might not be as effective as the traditional treatment.
You should have no out-of-pocket expenses for participating in a clinical trial. Either your insurance company or the research group will cover all of your health care expenses.
Your medical team works with the research team to ensure that the study does not interfere with your health care. The research team provides instructions, including follow-up visits. A clinical trial can be as short as a single visit, as long as several years, or anywhere in between.
All clinical trials follow a protocol designed to protect your health and answer specific research questions. The protocol outlines who can participate; the schedule of tests, procedures, medications, and dosages; and the length of the study. While you are in a clinical trial, our research staff will see you periodically to monitor your health and determine the safety and effectiveness of the treatment.
We protect our clinical trial volunteers in several ways:
- Federally regulated safeguards, including oversight by the U.S Department of Health and Human Services (HHS) Office for Human Research Protections and the U.S. Food and Drug Association (FDA)
- Use of a carefully controlled protocol or study plan
- Approval and monitoring by an Institutional Review Board (IRB)