Frequently Asked Questions

Anyone can join a clinical trial, and you don't need to have a terminal illness. 

Before joining, it's important to check if the study is right for you based on the disease or condition being studied. This helps ensure that the trial is a good match for your health needs and the research goals.

If you don’t qualify for a specific clinical trial, it means that you don’t meet certain criteria set by the study protocol. These criteria can include age, health condition, medical history, and medications you currently use. You can still discuss other options with your doctor, including standard-of-care or a different clinical trial that might be a better fit for you.

Clinical trials have safety measures, and participants can leave at any time. There are strict guidelines to make sure that all participants in a clinical trial are treated fairly and ethically.

The ethical and legal codes for medical practice also apply to clinical trials. Clinical research is regulated by government regulatory agencies with safeguards to protect participants. Every clinical trial must have a detailed study plan, called a protocol, that explains what the clinical trial doctors and staff will do. The protocol must be approved by an independent group called an ethics committee (EC) or Institutional review board (IRB) before the clinical trial can start. Clinical trials are also required to follow strict regulations to protect participants' privacy and confidentiality. Your personal information will be kept secure and used only for research purposes. It is your decision to join a clinical trial, and you can leave it at any time.

An Independent Ethics Committee (IEC) or Institutional Review Board (IRB) monitors the clinical trial to ensure participant protection rules are closely followed. The group can include doctors, statisticians, community advocates, and others. They review and approve the clinical trial plan, called a protocol, and the materials that might be given to the participants to protect their rights and safety before and during the research. In many clinical trials, an independent Data and Safety Monitoring Board (DSMB) also reviews data to ensure participant safety and sometimes efficacy.

Yes. Most clinical trials offer short-term treatments related to a specific disease or condition, but do not provide long-term or complete primary health care. By working with the clinical trial staff, your healthcare provider can ensure that other medications or treatments will not conflict with the protocol.

Yes. As the patient, you are always in full control of your treatment plan. If you decide that you no longer wish to be in a trial, you can leave at any time. There is no financial penalty, and you can still get medical care at the institution hosting the trial.

When leaving the clinical trial, you should let the clinical trial staff know when and why you are leaving.

When you join a clinical trial, you should expect to get at least the same level of care as you would from your regular doctor. Participants in a clinical trial get access to the investigational treatment being studied, which has not yet been approved, and the best currently approved and recommended care. Clinical trials may also offer more comprehensive monitoring as required by the clinical trial protocol.

Your treatment history will be considered as part of the trial enrollment process. Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, participants may need to stop their current treatments for a while. It's important to discuss your current treatment and the trial's requirements with your healthcare team to understand the best course of action for your individual situation. If the investigational treatment doesn't work, you can usually go back to your original treatment plan. The trial staff will discuss next steps with you when you finish or leave the trial.

Participating in a clinical trial can require a significant time commitment. The amount of time varies by the trial DESIGN and trial phase. Most clinical trials involve regular visits to the clinical trial site for tests, health monitoring, procedures, and even scans. But some trials do not need much more time than what is needed during a standard doctor visit. Talk to the trial staff about the time commitment when thinking about participating in a clinical trial.

Most clinical trial participants are not paid, but some participants are compensated for their expenses, such as travel. Healthy volunteers might be paid to take part in clinical trials that are testing the safety of an investigational treatment for the first time.

No, you do not need to have insurance to take part in a clinical trial. Usually, most of the costs in a trial are covered by the sponsor. If you have insurance, some costs may be covered by your health insurance. Coverage can vary depending on the trial and your insurance plan. It’s advisable to check with your insurance provider and the trial organizers to understand what costs may be covered.

• Access to investigational treatments or procedures before they are widely available
• More comprehensive health monitoring and high-quality medical care
• Play an important part in medical research

Learn more about the benefits and risks of clinical trial participation

• The investigational treatment may not work for you
• The investigational treatment may have expected and unexpected side effects
• In a randomized clinical trial, you can’t choose which treatment you get, so you may get standard of care for your condition or a placebo
• Clinical trial visits and requirements affect your daily life, and there may be some costs that are not covered by the clinical trial

Learn more about the benefits and risks of clinical trial participation