A clinical trial is a research study that may help find new ways to prevent, diagnose, and treat disease.
Clinical trials are conducted to test whether a new drug, new combination of drugs, new medical device, or new way to use an existing treatment works and is safe.
Before a doctor can write a prescription for a new medication, the United States Food & Drug Administration (FDA) requires that clinical trials be conducted to determine if a medication is safe and if it works in the disease or condition it is intended to treat.
Clinical research is medical research that involves volunteers like you. Every clinical trial is conducted according to a research plan, also called a “protocol”, that describes the clinical trial, including:
A clinical study is led by a principal investigator (PI), who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness.
The protocol helps to ensure the safety of study participants while also answering specific research questions. Most clinical trials in the U.S. are evaluated and monitored by an independent group of people, called an Institutional Review Board (IRB), who will approve the protocol and ensure it is ethical and the rights of study participants are protected.
If you decide to take part in a clinical trial, a member of the study staff will discuss the protocol with you, and you will have to give your “informed consent” in order to participate.
Each clinical trial carries its own specific risks. These are described in detail in the informed consent form that you will be asked to sign if you decide to participate in the trial. Before deciding to participate in a clinical trial, be sure to ask the study staff about any potential risks.
All medications and most medical procedures carry some risks. Participating in a clinical trial can involve some risks. Possible risks may include:
Benefits of participating in a specific clinical trial are described in detail in the informed consent form that you will be asked to sign if you decide to participate in the trial.
Your participation in a clinical trial may help other people in the future. Clinical trials may also provide other benefits, including:
Informed consent is when you are given key facts about the clinical trial and the investigational drug(s) or device(s), including possible risks and benefits, so that you can decide if you want to participate in the trial. Members of the research team will explain details about the study and answer questions to help you decide whether or not to participate.
Before any study related procedures, you will need to sign an informed consent form, which is a document that shows you understand certain details about the clinical trial, such as its purpose, duration, required and optional procedures, possible risks and benefits, and your obligations as a study participant.
The informed consent form is sometimes a lengthy document. You should take your time to review it, and to ask the study staff and study doctor questions. You may also review it with friends or family. Be sure to ask the study staff or study doctor for more information if there is something in the informed consent form that you do not understand.
Remember: signing the informed consent form does not mean that you have to stay in the clinical trial. It is your right to stop participating in the trial at any time, for any reason.
People who choose to participate in a clinical trial do so for very different reasons. Healthy volunteers say they participate to help others and help advance science. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff. Clinical trials provide an opportunity to help researchers find better treatments for others in the future.
Everyone who participates in a clinical trial must qualify for the study. Every protocol has specific guidelines, called eligibility criteria, that determine who can participate in the trial. Eligibility criteria may be based on factors such as age, gender, type of disease, medications you are currently taking, and other medical conditions you may have.
Eligibility criteria are designed to help keep study participants safe and also help researchers get the information they need from the clinical trial.