CTSI Clinical Research Champions

A clinical trial is a study where people volunteer to test new medicines or tools to find out what treatments work best to keep people healthy. Every trial follows a protocol that explains who can join, what tests or medicines will be used, how long the study will last, and what the researcher is looking for.

Clinical trials can focus on a specific condition or illness, or they can observe how certain interventions affect healthy volunteers.

There are many reasons to participate in trials! Some main ones include:

• Helping science & others! – Clinical trials are how we discover new things about how our bodies work and how they respond to different medicines.
• Financial benefit! – A lot of clinical trials provide some compensation for people who participate in them.
• Health screening! – Clinical trials will notify you of abnormal results on any tests they run, which is a great added benefit!
• Innovative treatment! – Some trials offer drugs that might not be on the market yet but could be beneficial to some patients.

Participation in clinical trials can be different for each study. Depending on the trial, patient volunteers may need more tests or visits to the doctor than they normally do, while others require fewer check-ins.

The schedule, length of study, and specific instructions participants should follow will all be explained and laid out during a visit if you sign up for a trial.

Coming to multiple visits during a clinical trial is important because it helps researchers collect information on how a treatment affects a person over time. For trials with healthy volunteers, these visits help researchers see how people progress over time. For trials developing therapies or drugs, the visits help researchers understand if the treatment is safe and if it is working well.

Meeting with participants over time also helps researchers see how a disease changes and how people respond to a treatment.

Your time participating in a clinical trial varies – some consist of 1 visit, but others consist of several across a few months. In total, clinical trials can take several years to finish as researchers need to recruit many participants. People join the study at different times, and researchers need time to collect information from everyone. After the study ends, the researchers also need time to look at the results before they share what they learned.

Before you join a study, the research team will explain it to you. This is called informed consent. They will tell you why the study is being done, what you will do, the possible risks and benefits, and answer your questions. You can choose to leave the study at any time

There are also groups that help keep people safe. They check that the study follows the rules and protects everyone who takes part.

Before your information is shared, your personal details are removed. This includes your name, phone number, email, and Social Security number. This helps protect your privacy.

If your information is used in another research study, there are laws about who can use it and how it can be used that keep your identity private.

An Institutional Review Board (IRB) is a group that checks if a study is safe before it starts. They make sure the study follows the rules and treats people fairly. The IRB checks the study every year. If there is a safety or privacy problem, they can ask the researchers to make changes or even stop the study.

There are many types of clinical trials – some want to look at new medications, others want to look at general health metrics. For many clinical trials, you will not need to take any additional medication. You will hear about the full requirements for a specific trial during the informed consent process, a visit during which you will hear all about the trial, ask questions, and sign a document giving your consent.

You can look up your study by using its NCT number, which is a unique study ID provided during the informed consent process. This can help you find updates and see the study results. You can also check your informed consent form. It may explain how and when the study team will share the final results with you.