If you are thinking about participating in clinical trials, you may have questions about what they are, how they work, and how they might benefit you. Below are some answers. Keep in mind, the trial research team and your doctor are your best sources for medical advice.
A clinical trial is medical research involving human volunteers, a lead investigator, and a research team made up of doctors, nurses, social workers, and/or other healthcare professionals. Trial participants receive medicines, medical devices, medical procedures, or behavioral help according to a research plan known as a protocol. The goal is to find out if a new treatment is tolerated and effective in people. Clinical trials can compare a new treatment to a standard existing one, to a placebo (a medicine with no active ingredients), or to nothing at all. Some clinical trials compare available treatments to each other.
Clinical trials are designed to add to our medical knowledge and can help us develop additional treatments. Some trials evaluate medicines, devices, or procedures that treat conditions. Other trials evaluate treatments that prevent conditions, yet other trials evaluate approaches for diagnosing conditions. But all clinical trials aim to help people lead healthier lives.
Clinical trials have eligibility criteria that determine who can take part in them. Your age, disease stage, sex, genetic profile, and family history can make you eligible for a clinical trial. Health conditions or medicines that could interfere with the trial treatment can keep you from being in one. Keep in mind, different trials have different eligibility criteria, so being excluded from one trial does not mean you will not be eligible for another.
While you learn more about clinical trials and consider ones that may be right for you, know there are several reasons to participate in a trial:
- It may provide you a new treatment option.
- It helps advance medical research and may help improve the health of future generations.
Clinical trials used to develop medicines are sometimes described by phase. Trials may advance through four phases to test the effectiveness of a treatment and discover side effects.
focuses on the safety of a treatment. Researchers are looking for the treatment’s most common and serious side effects. Usually, a small group of 20-80 healthy people is involved in a Phase I trial.
focuses on the effectiveness of a treatment. This phase aims to find out whether the treatment works in people who have a certain condition, though side effects are also studied. Phase II trials usually involve 100-300 people.
gathers more information about the safety and effectiveness of a treatment. In this phase, researchers study how the treatment works in different age groups, genders, ethnicities, and races, and how it works in different doses. Phase III trials usually involve several hundred to several thousand people.
occurs after a treatment is approved for use. A treatment’s effectiveness and safety is studied in thousands of people over a long period of time so more can be learned.
Clinical trials can last as little as one week and as long as four years or more. It depends on what is being studied. Participants are told how long the clinical trial will last before they enroll.
The research team will collect and analyze the trial data to determine what’s next. There could be a new trial or no further study of the treatment. When the trial ends, participants should be told whether they will keep receiving the trial treatment and how they will be informed about trial results.
Informed consent is a process that provides those participating in or considering a clinical trial information about that trial. The information helps people understand the risks, potential benefits, alternatives, and requirements of the trial. It helps people decide whether they want to enroll or remain in a trial.
Usually, people must sign an informed consent document before joining a trial to show that they were given the above information and that they understand it. Participants may withdraw from a trial at any time, even if it is not over. If you have any questions about a clinical trial, talk to members of the research team or your healthcare provider.
You will likely get the placebo (a medicine with no active ingredients).
Some clinical trials use a placebo, but usually participants are given the study treatment or an available standard treatment. The research team will let you know which treatments will be used before you enroll in a trial. In oncology trials such as DESTINY, you will receive a standard-of-care treatment, not a placebo.
Your insurance provider will not cover the costs.
In a study, 86% of clinical trial participants said their treatment was covered by insurance. Before participating in a clinical trial, ask your insurance provider about your coverage.
You will be treated like a “guinea pig.”
In a study of clinical trial participants, 97% said they were treated with dignity and respect during their trials and that the quality of care they received was “excellent” or “good.” Clinical trials are conducted by a team of doctors, nurses, social workers, and/or other healthcare professionals. Promising experimental treatments and available standard ones are studied. If you participate in a clinical trial, you can expect compassionate, quality medical care.