- You may get a new treatment for a disease before it is FDA-approved and available widely for use.
- You play a more active role in your own health care.
- You may have the chance to help others get a better treatment option for their health problems in the future.
- The new treatment may cause serious side effects or be uncomfortable.
- The new treatment may not work, or it may not be better than the standard treatment.
- What is the purpose of the study?
- Why do researchers think the approach may be effective?
- Who will fund the study?
- Who has reviewed and approved the study?
- How are study results and safety of participants being checked?
- How long will the study last?
- What will my responsibilities be if I participate?
- What are my possible short-term benefits?
- What are my possible long-term benefits?
- What are my possible short-term risks, such as side effects?
- What are my possible long-term risks?
- What other options do people with my disease have?
- How do the possible risks and benefits of this trial compare with those options?
- What kinds of therapies, procedures, and/or tests will I have during the trial?
- Will they hurt, and if so, for how long?
- How do the tests in the study compare with those I would have outside of the trial?
- Will I be able to take my regular medications while participating in the clinical trial?
- Where will I have my medical care?
- Who will be in charge of my care?
- How could being in this study affect my daily life?
- Can I talk to other people in the study?
- Will I have to pay for any part of the trial, such as tests or the study drug?
- If so, what will the charges likely be?
- What is my health insurance likely to cover?
- Who can help answer any questions from my insurance company or health plan?
- Will there be any travel or child care costs that I need to consider while I am in the trial?
- Will I be asked to keep any diaries or records at home?
- How often will I visit the clinical trial site?
- Will I have to travel far to take part in the trial?
- Will I be able to bring a caregiver with me?
You may want to print a copy of these questions to take with you when meeting with your doctor or the trial doctor and staff. For more information on questions to ask about clinical trials, please visit the NIH website.
- Help your loved one maintain routines as much as possible.
- Encourage your loved one to express emotions.
- Remember that people communicate in different ways.
- Be realistic and flexible about what you hope to talk about.
- Respect your loved one's need to be alone. We all need time alone occasionally—even you.
- Talk with the clinical trial doctor and staff about support for caregivers.
The process of taking part in a clinical trial depends on the research being conducted. Generally, the trial doctor and staff will:
- Check your health at the beginning of the clinical trial to see if you are eligible to participate.
- Provide specific instructions and guidance for what to do during the trial.
- Monitor your health throughout the trial.
- Administer the investigational drug (or placebo).
- Ensure that the guidelines for the clinical trial are followed.
If you choose to join a clinical trial, you will need to:
- Follow instructions from the trial doctor and staff.
- Go to the clinical trial site to complete trial-related activities, such as receiving the study drug, having medical tests, and answering questionnaires.
- Complete some trial-related activities at home (for example, taking your study drug between visits, talking with the trial doctor and staff by phone, and answering questionnaires).
- Communicate openly and honestly with the trial doctor and staff.
- Follow requirements related to lifestyle issues, such as diet, exercise, and contraception.
- NOT take part in another trial at the same time.
Every clinical trial has strict eligibility criteria to help determine who can take part. If you are interested in taking part in a clinical trial, the trial doctor and staff will check to see if you meet the criteria during a screening period. This may involve certain assessments and questionnaires. Ultimately, the trial doctor is the one who determines whether someone is eligible to participate, not the sponsor of the trial.
Common eligibility criteria for joining our clinical trials include:
- Having a certain type or stage of cancer or disease
- Having received (or not having received) a certain kind of therapy in the past
- Having specific genetic changes in your medical condition
- Being in a certain age group
- Being healthy enough to receive an investigational drug
- Additional eligibility criteria may apply. Your trial doctor will discuss this with you
All clinical trials follow a plan called a protocol. A protocol is a written document that describes the rationale, objectives, design, and organization of the trial. For example, a protocol describes the type of people who are eligible to participate, the length of the trial, and the required procedures.
Yes. A clinical trial does not replace your regular medical care. You should let other doctors you see know that you are in a clinical trial. You should also let the trial doctor and staff know about care you receive outside of the trial.
Eligibility criteria help trial doctors to determine if an individual is right for a trial, but it’s just as important that the individual determines if the trial is right for them. That’s why every clinical trial has an informed consent process that potential participants must go through before they take part. This process involves providing individuals with enough information about the trial and enough time to allow for an informed decision about participation. This information is outlined in an informed consent form (ICF) that potential participants must read and sign before they can take part in the trial. This form includes key facts about the trial, like why it is being conducted and what the risks and benefits are of taking part. By signing this form, participants are showing that they understand what taking part involves. This form is not a contract – participants may leave the trial at any time.
Yes. Your participation in a clinical trial is voluntary. You can choose to stop participating in a trial at any time. Your decision to leave a clinical trial will not affect medical care you receive outside the trial. Leaving will not result in any penalty or loss of benefits to which you are otherwise entitled. If you choose to leave a clinical trial, please contact your trial doctor.
Every trial is different, but usually participation is free. The trial sponsor often covers the cost of the trial drug and the necessary physician visits and tests performed for the trial. Sometimes, a participant’s insurance will be billed for care not related to the trial. Support for travel to clinic visits may also be provided. Please discuss this with your trial doctor.
Once a trial has been completed and researchers have appropriately analyzed the results, data from the trial are typically announced by the trial sponsor. Research participants can learn more about trial results from their physician.
ClinicalTrials.gov is a database that is independently operated by the U.S. National Institutes of Health to help patients and researchers locate and learn more about clinical trials. It lists privately and publicly supported clinical trials of human participants conducted around the world. Patients may also reach out to the trial physician directly.