Learn About Clinical Trials
What is medical research?
Clinical research studies (also known as “clinical trials”) test investigational medications or medical devices. These trials must include human participants before it can be approved and prescribed to patients.
The goal of a clinical trial is to learn if an investigational medication or medical device (the “investigational product”) is safe and how well it works. If an investigational product has been successful in clinical trials, pharmaceutical and biotechnology companies submit the trial results to regulatory agencies, to seek approval for their product to be prescribed to patients.
Clinical trials can also be conducted to learn more about medications after they have been approved. This helps doctors and researcher to understand how the approved product works in the “real world”. They can also learn if the approved medication can be used in a different way or can treat a different condition.
It is important to continue research even after approval so we can learn as much as possible about any medication.
Researchers must follow very strict rules to ensure the safety and well-being of everyone taking part in a clinical trial.
Clinical trials are carefully monitored by various regulatory agencies, such as: • US Food and Drug Administration (FDA) in the United States • European Medicines Agency (EMA) in Europe • Other Ministries of Health or regulatory authorities in countries around the world. These government agencies are responsible for the rules and regulations on the conduct of clinical trials.
Are clinical trials safe?
Institutional Review Boards and Ethics Committees
Institutional Review Boards (IRBs) and Ethics Committees (ECs) are responsible for reviewing proposed and ongoing clinical trials to make sure there are appropriate steps in place to protect the rights and welfare of participants. They are made up of scientists, doctors, and other experts, as well as lay members of the community.
What is it like to take part in a clinical trial?
The first step is finding out all about the trial before deciding whether you want to take part. This process is called informed consent. If you agree to take part, researchers will see if you are eligible to participate during a process called “screening”. Screening may involve some medical tests and assessments. Different trials have different requirements.
Why do people take part in clinical trials?
Some people participate in clinical trials to contribute to medical research and to help doctors find new ways to help patients. Others take part because their condition is not responding to standard treatment. However, there is no guarantee that an investigational product will work.
It is important that all kinds of people are represented in clinical trials. This is because certain conditions and medications may affect people differently based on their age, sex, race/ethnicity, and their genes. Without clinical trials, improvements to current treatments and medical technologies would not be possible.
What are the risks?
Side effects of an investigational product are not always known. In clinical trials of a product that is approved for use in people already, some of the side effects may be known but not all of them. Researchers must tell you about any known risks and also discuss the potential for unknown risks before you decide whether to take part in a clinical trial.
Most side effects are minor and merely unpleasant. However, sometimes side effects can be more serious or even life-threatening. The risks vary, depending on the product being tested.
Clinical trial participants can stop taking part in a trial at any time and for any reason.
As a trial participant, how am I protected?
Informed consent
Researchers are required to provide you with complete information about the trial before you decide whether to participate. This process is called getting informed consent. You should not agree to participate in a trial unless you understand all the details in the Informed Consent Form (ICF). You can ask questions if you are not sure about anything.
All potential trial participants must be given information about:
• purpose of the trial
• amount of time they will be in the trial
• possible risks and benefits of taking part
• other procedures or treatments that are available
• privacy of their medical records (although researchers, IRBs/ECs, and regulators may review them)
• treatments that are available if they become sick or hurt because of taking part, and who will provide payment for any needed treatment
• contact information for the person who can answer questions about the trial.
If you agree to take part after reading and understanding all the information, you will need to sign the ICF. Even after signing, you can leave the trial at any time and for any reason without penalty.