Benefits and Risks of Taking Part in a Clinical Trial

Potential Benefits

Clinical trial participants have access to investigational treatments.

People in clinical trials have the chance to get potential new treatments or procedures that are not available to the public yet. These include:

• Investigational treatments for cancers that do not respond to other treatment options
• Investigational gene therapy for rare diseases that have no other treatment options
• Investigational vaccines to help prevent disease

Clinical trial participants get high-quality medical care.

The care that trial participants get is held to a high standard. Clinical trial researchers monitor participants carefully to see how they respond to the investigational treatment and if they have any side effects. Some clinical trials use tools – such as surveys – to check how the treatment affects the participant’s quality of life. These tools can help guide better treatment decisions.

Clinical trial participants help others by advancing medical research

Taking part in a clinical trial helps sponsors gather important information about how the investigational treatment works and helps increase their understanding of the condition or disease. Sponsors may also learn of new ways to treat or monitor the condition or disease.

By joining a clinical trial, you also help sponsors learn if the investigational treatment works for someone like you. Many factors can affect how well a treatment works, including a patient’s age, sex, and racial and ethnic background. Diversity and representation in clinical trials help ensure that a treatment – once approved – will benefit all patients.

Potential Risks of Clinical Trials

While clinical trials try to reduce risks, side effects can still happen. Sponsors take steps to predict and watch for side effects closely, but the investigational treatment is still being tested.

If you do have any side effects, tell the clinical trial staff right away. You should also tell them about any changes in how you feel, even if you do not think the change is caused by the clinical trial or the investigational treatment. The study team must help with any trial complications and minimize lasting effects on your health. So, always speak up about any discomforts, as small reactions could signal new risks.

A clinical trial cannot guarantee a positive outcome

When an investigational treatment is first tested in a clinical trial, it starts with a small group of people. Sponsors watch the safety of the investigational treatment closely before giving it to more people. If the investigational treatment meets certain standards for safety and efficacy in smaller trials, it is tested in larger trials. This step-by-step method helps protect participants from investigational treatments that might have more risks than benefits.

Even so, investigational treatments studied in clinical trials are not approved for the disease or condition being studied. The treatment might not work, or it might not be better than what is already available. It might also have side effects that currently available treatments do not.

Before you decide to join a clinical trial, someone from the clinical trial site will explain these risks to you. That way you can make an informed decision through a process known as informed consent.

You may have unpleasant, serious, or unknown side effects

Each phase of clinical research aims to understand more about the potential benefits and risks of the investigational treatment. However, not all possibilities are known, so there may be unexpected risks.

You might be assigned to a control group

Another uncertainty in clinical trials might be the treatment you get. You might be assigned to get the investigational treatment, or you might be assigned to a control group. Many trials use a control group. That allows researchers to compare the effects of the investigational treatment to those of a currently available treatment, or to those of no treatment at all.

Sometimes, the control group in a clinical trial will be offered the investigational treatment after a period of time.

Before you decide to join a clinical trial, someone from the clinical trial site will talk to you about:

• The investigational treatments available in the clinical trial
• Your chances of getting the investigational treatment
• The medical care you will get during the clinical trial, regardless of your treatment assignment

Taking part in a clinical trial takes time and effort

One of the benefits of taking part in a clinical trial is that trial sites must watch your health and safety closely. This often means you get high-quality medical care. But it also might mean that you have to go to longer medical appointments or do medical tests more often. You might also need to do some activities at home, such as filling out surveys or keeping a diary.

Benefit-Risk Balance

While there are risks in joining a clinical trial, clinical trials are designed to minimize these risks. Clinical trial staff follow strict research protocols about your care. Before a clinical trial can begin, these protocols must be approved by Institutional Review Boards and Ethics Committees. These are independent groups that make sure that you are not at unnecessary risk. Once a clinical trial is under way, it is monitored by government regulatory agencies and the sponsor. Some trials also have safety boards that regularly review the trial data. They weigh the benefits to participants against the potential risks.

Because of this care and oversight, the benefits of joining a modern-day clinical trial may be greater than the risks or burden. In a 2019 survey by the Center for Information and Study on Clinical Research Participation (CISCRP), of more than 3,000 clinical trial participants, 78% said their clinical trial met, exceeded, or greatly exceeded their expectations. And 71% said they would be very willing to take part in another clinical trial in the future.

However, the decision to take part in a clinical trial (or not to take part) is personal. The important thing is to make an informed decision – considering all of the benefits and risks for that particular trial. You can get help from the clinical trial staff, a trusted health care provider and people you trust or rely on for support, such as a family member or friend.

Even after careful consideration, you might not qualify for the clinical trial

Before you can join a clinical trial, you and the clinical trial staff need to make sure the clinical trial is right for you. It’s not just a matter of having the disease or condition that the clinical trial drug is being developed to treat. For example, a clinical trial for an investigational cancer treatment might only include patients with an advanced form of cancer. Or it might include only those who have already tried certain other treatments with little or no success. Another person might meet the disease requirements, but they might also have another condition that makes it unsafe for them to join.

The clinical trial’s criteria for who can join exists for a good reason. The goal of any clinical trial is to study investigational treatments for people who are likely to benefit, while reducing risks.

If you decide that you want to join a clinical trial, the clinical trial site staff will help check if you meet the criteria. If that trial is not right for you, there may be another one that’s a better fit. The clinical trial site might be able to give you some resources to find another trial. But if not, you can search websites such as ClinicalTrials.gov as well as this website to see if there are other options for you.

Find an Astellas Clinical Trial Near You

Search Astellas Clinical Trials to see if any might be a match for you or for someone you care about.