Benefits and Risks of Participating in a Clinical Trial

People join clinical trials for a variety of reasons. While there can be many benefits to joining a trial, there are also possible risks. It’s important to understand both before deciding whether or not to participate.

Potential Benefits

Clinical trial participants have access to experimental treatments.

Trial participants have the chance to receive potential treatments or procedures that are not yet available to the general public. These include potential treatments for cancers that have not responded to other treatment options, potential treatments for rare diseases that currently have no other treatment options, and new vaccines to help prevent disease.

Clinical trial participants receive high-quality medical care.

The care that trial participants receive is held to a high standard. Trial doctors monitor participants carefully to see how they are responding to the experimental treatment and if they are having any side effects. Some clinical trials use tools – such as surveys – that directly measure the impact of the experimental treatment on the participant’s overall quality of life. These tools can be used to help guide better treatment decisions.

Clinical trials might offer a close-to-home experimental treatment option.

Many clinical trials are “multicenter studies,” which means there are multiple trial sites available to participants. A clinical trial might offer someone the chance to get the care they need by participating at an office or a hospital that is close to home rather than requiring them to travel to see a specialist. If you are interested in joining a clinical trial, websites such as ClinicalTrials.gov , as well Astellas Clinical Trials can help you learn about trials happening in your area. A trial site that is close to home can make access a lot more convenient. Alternatively, if travel is required to reach a trial site, the trial sponsor might be able to assist with travel costs and arrangements.

Potential Risks

A clinical trial cannot guarantee a positive outcome.

When an experimental treatment is first tested in a clinical trial, it is studied in a small number of participants. Researchers carefully monitor the safety of the experimental treatment before it is given to a larger group of people. If the experimental therapy meets certain standards for safety and efficacy in smaller trials, it is tested in larger trials. This incremental approach helps limit trial participant exposure to experimental treatments for which the risks of side effects outweigh the likelihood of benefit. Even so, experimental treatment studied in clinical trials are not approved for the disease or condition under study. The experimental treatment might not work, or it might not offer advantages over what is already available to the public. It might have side effects that currently available treatments do not. Before you decide to join a trial, someone from the trial site will explain these risks to you so you can make an informed decision.

You might be assigned to a control group.

Another uncertainty in clinical trials might be the treatment you receive. You might be assigned to receive the experimental treatment, or you might be assigned to a control group. Many trials use a control group so that the effects of the experimental treatment can be compared to the effects of a currently available treatment, or to the effects of no treatment at all. Before you decide to join a trial, someone from the trial site will talk to you about the experimental treatments available in the trial, your chances of receiving the experimental treatment, and the medical care you will receive during the trial, regardless of your treatment assignment.

Clinical trial participation involves time and effort.

One of the benefits of participating in a clinical trial is that trial sites are required to closely monitor participant health and safety. This often leads to high-quality medical care, but it also might require participants to commit to longer medical appointments and/or more frequent medical tests. Participants may also be asked to complete certain activities, such as surveys or diaries, at home.

You might not qualify for the trial.

Before you can join a clinical trial, you and the trial doctors need to make sure the trial is right for you. It’s not just a matter of having the disease or condition that the trial drug is being developed to treat. For example, a trial evaluating a new treatment for cancer might be limited to enrolling patients with advanced or metastatic breast cancer, or to patients who have already tried certain other treatments with little or no success. Alternatively, a potential participant in the same breast cancer trial might meet the requirements for the disease under study guidelines, but they might also have another medical condition – such as heart disease - that might make it unsafe for them to receive an investigational treatment. The trial’s eligibility criteria exist for a good reason – the goal of any clinical trial is to test treatments for patients who are likely to benefit, while minimizing the risk of negative outcomes. If you decide that you want to join a trial, the trial site staff will help determine if you meet the trial’s eligibility criteria. If that trial is not right for you, there may be another one that’s a better fit. The trial site might be able to give you some resources you need to find another trial, but if not, you can search websites such as ClinicalTrials.gov as well as Astellas Clinical Trials to see if there are other options for you.

Benefit-Risk Balance

While there are risks associated with trial participation, clinical trials are designed to minimize these risks and prioritize each participant’s health, safety, and well-being. Clinical trial staff follow strict research protocols that describe the care participants will receive. Before a clinical trial can begin, these protocols must be approved by Institutional Review Boards and Ethics Committees – groups that are dedicated to making sure that clinical trial participants are not exposed to unnecessary risk. Once a clinical trial is under way, it is monitored by health authorities and the trial sponsor. Some trials also have dedicated safety monitoring boards that periodically review the trial data to weigh the benefits to patients against the potential risks. As a result of the care and oversight that are built into modern-day clinical trials, the benefits of participation may outweigh the risks or burden of participation. In a 2019 survey of more than 3,000 clinical trial participants conducted by the Center for Information and Study on Clinical Research Participation (CISCRP), 78% of respondents said their clinical trial met, exceeded, or greatly exceeded their expectations, and 71% said they would be very willing to participate in another clinical trial in the future. However, the decision to participate in a clinical trial (or not participate) is a personal one. The important thing is to make an informed decision – considering all of the benefits and risks for that particular trial - with the help of the trial site staff, a trusted health care provider and others you trust or may rely on for support - such as a family member or friend.