Curious About Clinical Studies? Here’s What You Can Expect as a Participant

If you’ve ever wondered what a clinical study is, or what it would be like to participate in one, you’re not alone. You probably have a lot of questions about what the process involves and what to expect.

In this blog, we’ll break down what a clinical study is, explain what it means to be a participant, and give you a clear idea of what to expect if you decide to join a clinical study.

What is a Clinical Study?

Before treatments become available to the public, they need to be tested to make sure they work as expected and are safe for patients. A clinical study is a type of research study that investigates treatments, medicines, or therapies to see if they are safe and effective. This could include anything from an investigational medication to a device or a different approach to therapy. The goal is to find out what works for treating certain health conditions and make more options available to patients. 

Clinical studies happen in different phases. In the early phases, the focus is on making sure the investigational treatment is safe for people to use. In the later phases, researchers test whether it works well and how it compares to the treatments that may already be available or to receiving no treatment.

What Does It Mean to Be a Clinical Study Participant?

Being a study participant means you are volunteering to be part of a study where researchers test an investigational drug, or medical device. The goal is to help doctors and scientists understand whether the investigational treatment works and if it is safe for patients.

Clinical studies are carefully planned and are closely monitored by a team of doctors, nurses, and other healthcare professionals who are there to support you every step of the way.

Before you may join, you’ll go through a process called informed consent. This means you’ll get detailed information about what the study involves—what investigational treatments you might get, any risks involved, and your rights as a participant. You’ll also be told that you can leave the study at any time if you choose to.

What Can You Expect as a Clinical Study Participant?

Each clinical study is different, but there are some common things you can expect as a participant.

1. Informed Consent Process - Understanding Your Role
   The first step is a detailed conversation between you and the research team. They will explain the purpose of the study and what will happen during it, as well as any possible risks or side effects. 

You’ll be given a document called an Informed Consent Form to read, and you’ll have the chance to ask any questions. This is your time to make sure you fully understand what you’re agreeing to before you participate. If you have any concerns, you can take your time and talk to the research team. 

1. Screening to See if You Qualify
   Once you agree to participate and give your consent, you’ll go through a screening process to see if you meet the criteria to join the study. You may be asked about your health history, medications, and may need to undergo a physical exam and/or some lab tests. Not everyone qualifies for every study, and that is okay.
2. Receiving the Investigational Treatment
   In many studies, participants are randomly assigned to one of two or more groups. One group may receive the investigational treatment being tested, while the other group may receive a placebo (a placebo looks the same as the investigational medicine but contains no actual medicine). This helps the researchers compare how the investigational treatment works against no treatment at all. 
3. Regular Check-Ups and Monitoring
   Throughout the study, you will likely need to visit the clinic or research center regularly. Some studies allow for some of these visits to be done virtually or over the phone. These visits help the site staff monitor how you’re doing, check for side effects, and see how the investigational treatment is affecting your health. You may have physical exams, lab tests, or imaging done as well.

In addition to medical tests, you might be asked to fill out surveys, diaries, or questionnaires. These may ask about how you’re feeling, your symptoms, or how the investigational treatment is affecting your day-to-day life. Depending on the type of study, they may also ask you to track certain activities that you complete. This feedback helps doctors evaluate how well the study treatment is working.

1. Reporting Side Effects
   All investigational treatments come with some risk of side effects. During the study, you’ll be asked to report any symptoms or changes in your health. The study doctor and site staff will monitor for any problems and make sure you’re getting the medical attention you need. You should feel comfortable discussing any side effects or concerns with the site staff at any time.
2. Length of the Clinical Study
   Clinical studies can last anywhere from a few weeks to several months or even years. The exact duration depends on the study’s goals and the investigational treatment being tested. You’ll be told up front how long the study will last, and you should make sure you’re comfortable with the timeline before you decide to participate.
3. Privacy and Confidentiality
   Your privacy is very important. Any personal information you share during the study is kept confidential, and your health data will be protected. Clinical studies follow strict rules to ensure your information stays private.

Is a Clinical Study Right for You?

Participating in a clinical study is a personal decision. It can be a way to contribute to the advancement of medical research. While there are risks, the site staff will work closely with you to monitor your health throughout the process.

If you’re considering joining a clinical study, talk to your doctor. They can help you understand whether a particular study might be a good fit for you based on your health history and current treatment plan. Remember, your participation is completely voluntary, and you can withdraw at any time without any impact on your regular care.

Final Thoughts

Clinical studies are a key part of discovering more treatments, and your involvement may make a difference in contributing to scientific knowledge about your condition and future treatment options. As a participant, you would be contributing to research that allows for a better understanding of how investigational treatments work that may benefit people in the future. 

If you’re considering participating, take your time to learn more, ask questions, and make the decision that feels right for you.